[House Hearing, 111 Congress]
[From the U.S. Government Publishing Office]
JOHNSON & JOHNSON'S RECALL OF CHILDREN'S TYLENOL AND OTHER CHILDREN'S
MEDICINES
=======================================================================
HEARING
before the
COMMITTEE ON OVERSIGHT
AND GOVERNMENT REFORM
HOUSE OF REPRESENTATIVES
ONE HUNDRED ELEVENTH CONGRESS
SECOND SESSION
__________
MAY 27, 2010
__________
Serial No. 111-104
__________
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COMMITTEE ON OVERSIGHT AND GOVERNMENT REFORM
EDOLPHUS TOWNS, New York, Chairman
PAUL E. KANJORSKI, Pennsylvania DARRELL E. ISSA, California
CAROLYN B. MALONEY, New York DAN BURTON, Indiana
ELIJAH E. CUMMINGS, Maryland JOHN L. MICA, Florida
DENNIS J. KUCINICH, Ohio JOHN J. DUNCAN, Jr., Tennessee
JOHN F. TIERNEY, Massachusetts MICHAEL R. TURNER, Ohio
WM. LACY CLAY, Missouri LYNN A. WESTMORELAND, Georgia
DIANE E. WATSON, California PATRICK T. McHENRY, North Carolina
STEPHEN F. LYNCH, Massachusetts BRIAN P. BILBRAY, California
JIM COOPER, Tennessee JIM JORDAN, Ohio
GERALD E. CONNOLLY, Virginia JEFF FLAKE, Arizona
MIKE QUIGLEY, Illinois JEFF FORTENBERRY, Nebraska
MARCY KAPTUR, Ohio JASON CHAFFETZ, Utah
ELEANOR HOLMES NORTON, District of AARON SCHOCK, Illinois
Columbia BLAINE LUETKEMEYER, Missouri
PATRICK J. KENNEDY, Rhode Island ANH ``JOSEPH'' CAO, Louisiana
DANNY K. DAVIS, Illinois ------ ------
CHRIS VAN HOLLEN, Maryland
HENRY CUELLAR, Texas
PAUL W. HODES, New Hampshire
CHRISTOPHER S. MURPHY, Connecticut
PETER WELCH, Vermont
BILL FOSTER, Illinois
JACKIE SPEIER, California
STEVE DRIEHAUS, Ohio
JUDY CHU, California
Ron Stroman, Staff Director
Michael McCarthy, Deputy Staff Director
Carla Hultberg, Chief Clerk
Larry Brady, Minority Staff Director
C O N T E N T S
----------
Page
Hearing held on May 27, 2010..................................... 1
Statement of:
Goggins, Colleen, worldwide chairman, Consumer Group, Johnson
& Johnson.................................................. 61
Sharfstein, Dr. Joshua M., Principal Deputy Commissioner,
Food and Drug Administration, accompanied by Deborah M.
Autor, Director of the Office of Compliance, Center for
Drug Evaluation and Research, Food and Drug Administration,
and Michael A. Chappell, Acting Associate Commissioner for
Regulatory Affairs, Food and Drug Administration........... 12
Letters, statements, etc., submitted for the record by:
Connolly, Hon. Gerald E., a Representative in Congress from
the State of Virginia, prepared statement of............... 46
Goggins, Colleen, worldwide chairman, Consumer Group, Johnson
& Johnson, prepared statement of........................... 64
Issa, Hon. Darrell E., a Representative in Congress from the
State of California:
Letter from McNeil Consumer Healthcare................... 56
Prepared statement of.................................... 10
Kucinich, Hon. Dennis J., a Representative in Congress from
the State of Ohio:
FDA inspection report.................................... 77
Inspection report........................................ 81
Memo dated May 10, 2010.................................. 79
Sharfstein, Dr. Joshua M., Principal Deputy Commissioner,
Food and Drug Administration, prepared statement of........ 17
Towns, Chairman Edolphus, a Representative in Congress from
the State of New York, prepared statement of............... 3
JOHNSON & JOHNSON'S RECALL OF CHILDREN'S TYLENOL AND OTHER CHILDREN'S
MEDICINES
----------
THURSDAY, MAY 27, 2010
House of Representatives,
Committee on Oversight and Government Reform,
Washington, DC.
The committee met, pursuant to notice, at 10:04 a.m., in
room 2154, Rayburn House Office Building, Hon. Edolphus Towns
(chairman of the committee) presiding.
Present: Representatives Towns, Cummings, Kucinich,
Tierney, Clay, Watson, Connolly, Quigley, Norton, Davis,
Speier, Issa, Westmoreland, Bilbray, Jordan, Chaffetz,
Luetkemeyer, and Cao.
Staff present: John Arlington, chief counsel--
investigations; Kevin Barstow, investigative counsel; Adam
Hodge, deputy press secretary; Carla Hultberg, chief clerk;
Marc Johnson and Ophelia Rivas, assistant clerks; Jenny
Rosenberg, director of communications; Leneal Scott, IT
specialist; Christopher Staszak, senior investigative counsel;
Ron Stroman, staff director; Gerri Willis, special assistant;
Alex Wolf, professional staff member; Lawrence Brady, minority
staff director; John Cuaderes, minority deputy staff director;
Rob Borden, minority general counsel; Adam Fromm, minority
chief clerk and Member liaison; Kurt Bardella, minority press
secretary; Stephen Castor, minority senior counsel; and Ashley
Callen, minority counsel.
Chairman Towns. The committee will come to order.
Good morning and thank you for being here.
Any time we give our children or grandchildren medicine,
like this bottle of Children's Tylenol that was included in the
recall, we expect it to be safe and we expect it to help the
children get better, not create problems for them.
When questions are raised about whether children's medicine
is safe, parents need immediate answers. Almost every household
in this country has these children's products in their medicine
cabinets. And everyone has the same question this morning: Are
these products safe, and what are we doing to ensure safety and
to make certain that this does not happen again?
While we do not want to cause unnecessary alarm, we also
cannot ignore the troubling facts before us.
Less than a month ago, a Johnson & Johnson company known as
McNeil Consumer Healthcare recalled over 40 variations of
children's medicine, including such widely used products as
Children's Tylenol, Children's Motrin, Children's Benadryl and
Tylenol Infants' Drops.
This recall was carried out because of production problems
at McNeil that affected the quality, purity and potency of the
medicine. McNeil received dozens of consumer complaints about
foreign particles in children's medicine, which were later
confirmed by McNeil.
In addition, tests at the plant show that three batches of
Infant's Tylenol were found to be ``super potent,'' meaning
that they contained an overdose of the active ingredient.
McNeil's production of children's medicine was shut down by
the company and a month later it still is shut down. The FDA is
currently investigating any possible links between the recalled
medicine and adverse health effects on children who took that
medicine.
The FDA is also currently reviewing reports of children who
died to determine if there is any connection between those
deaths and this recall. At this point, the FDA is not aware of
any connection between the recalled medicine and the death of
any child.
One document the committee received from the FDA refers to
the case of a 1\1/2\-year-old girl who died. That document
reads, ``coroner's office called to report the death of a 1\1/
2\-year-old female that is suspected to be related to a Tylenol
product.''
Just last night, the committee obtained from the FDA even
more disturbing information. According to an FDA document,
McNeil knew there was a potential problem with one of its
Motrin products that was on the market in 2008, but rather than
issue a public recall, McNeil allegedly sent contractors out to
stores to buy the product back and told the stores ``not to
mention'' a recall.
After the FDA confronted McNeil about this, McNeil
officially enacted a recall on the affected products.
If true, this ``phantom recall'' attempt by McNeil could
have endangered the public and warrants further investigation
by this committee.
We need to know what health risks are associated with this
recall. We need to know whether this is an isolated issue, or
part of a widespread problem with the safety and production of
children's medicine at McNeil. We need to know what Johnson &
Johnson is doing to get to the bottom of this. And we need to
know what the FDA is doing to ensure the safety of children's
medicine and whether the FDA has the resources it needs to
carry out its mission.
Both Johnson & Johnson and the FDA will be asked very
difficult questions today and I hope they are prepared to give
us the answers that will assure safety of these medications.
This is our first hearing on this issue, but there may be
more. We will follow this road until we have all the answers
and the questions raised by the American people are answered.
There is nothing this committee will investigate that is
more serious than the health of our children. I can assure you
that, as chairman of this committee, and I know on this matter
I also speak for the ranking member when I say this, we will
use all of our authority to find out what went wrong and do
everything that we can to ensure that it does not happen again.
[The prepared statement of Chairman Edolphus Towns
follows:]
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Chairman Towns. On this note, I yield 5 minutes to the
ranking member of the committee, Congressman Issa, from the
great State of California. Mr. Issa.
Mr. Issa. Thank you, Mr. Chairman. And you are right, you
speak for both of us when you say we will use all efforts of
this committee and all power of this committee to ensure this
does not happen again.
Johnson & Johnson has owned the McNeil Consumer Healthcare
Division since 1959, so for, one, from this day forward, I will
say Johnson & Johnson and not talk about a subsidiary that has
been owned by a company for so long.
Before I came to the Congress, I was a manufacturer. I
understand ISO 9001; certainly a good, but lesser standard than
what we expect medical items and food items to be held to. But
there is no question that my manufacturing techniques were less
than I would have expected if I were going to put a product in
my mouth.
Producing electronics, you want it to work and you want it
to work reliably. You want it to work consistently and you want
it to never hurt anyone. But my company knew that we would
produce a product that from time to time would be installed
poorly. We knew that from time to time we would have a bad
transistor, resistor, or diode. We did not produce to aviation
specs because, to be honest, an alarm going off because of a
malfunction was less of a problem.
But today we are talking about a market leader, a leader
who had so much confidence of the American people that we never
question their products or their services; whose creed was all
about safety and reliability. And they have disappointed us.
We are not the committee of manufacturing. We are not the
committee of jurisdiction directly over healthcare products or,
for that matter, any of the manufacturing sector in this
country. That is for other committees. What we are is the
committee that oversees Government's overseeing of its
responsibility.
Today we have before us the FDA. And much like the National
Transportation Safety and other parts of the Department of
Transportation, we have an agency who has done their job. They
have delivered report after report of problems and they have
come to a final conclusion before coming to this committee of a
massive recall.
So like Akio Toyoda, we would hope that Johnson & Johnson
comes ready to say this is a mistake that will not happen
again; that the company will in fact change how it does
business so significantly as to never be before us again.
But as to the FDA, I am encouraged that they have done
their job, but I am disappointed that it took so long. As with
the national transportation questions that we had before
Secretary LaHood, today I will be interested to know what
changes at FDA would allow for, if you will, shortcuts to this
conclusion. How do we find that a manufacturing technique that
is below standard is corrected more quickly? How do we ensure
that there are no backdoor or, if you will, unannounced
recalls? And how do we ensure that the FDA has all of the
authority and financing that it needs to ensure the American
people that not just a 120-year-old company, well regarded and
able to pay for all the cost of their mistakes, but that every
piece of over-the-counter or prescription medicine or, for that
matter, food, whether domestic or foreign import, as so much is
today, is safe?
I am deeply concerned, Mr. Chairman, that Johnson & Johnson
is the tip of the iceberg. If one of the most reliable and
responsible organizations in America and a company with great
connections to the community can fail us, then what about those
aspirins and other products that are more and more being
imported from outside our country, from factories that are
harder to reach and people who do not even speak our language
when we go to inspect them?
So although today is about Johnson & Johnson, and I hope
the second panel does their job of explaining why they will not
be in front of us again, I am most interested in the first
panel. What do we need to do, as the Committee on Oversight and
Government Reform, to ensure that you are able to do your job
worldwide, safely, so the American people can sleep knowing
that these kinds of medicines, no matter where they are made in
the world, will be absolutely safe from this day forward?
I thank the chairman and yield back.
[The prepared statement of Hon. Darrell E. Issa follows:]
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Chairman Towns. I would like to thank the gentleman from
California for his statement and, of course, I want you to know
that I agree with you.
I would like to just recognize the Brooklyn Friends School
who is here. Thank you very much for joining us this morning.
Mr. Issa. Could you please stand up? You can't be
recognized when you are--there we go.
Chairman Towns. Brooklyn Friends School. Thank you so much
for joining us this morning.
We turn now to our first witness. Dr. Joshua Sharfstein is
the Principal Deputy Commissioner of the Food and Drug
Administration. He is our witness today from the FDA, but he is
accompanied by Deborah Autor and Michael Chappell, who will not
be making opening statements, but are here to provide any
additional expertise that may be helpful to the committee.
Deborah Autor is the Director of the Office of Compliance at
the Center for Drug Evaluation and Research at the Food and
Drug Administration and Michael Chappell is the Acting
Associate Commissioner for Regulatory Affairs at the FDA.
It is committee policy that all witnesses are sworn in, so
if you would stand and raise your right hands while I
administer the oath.
[Witnesses sworn.]
Chairman Towns. You may be seated.
Let the record reflect that the witnesses answered in the
affirmative.
Dr. Sharfstein, being the only person making opening
statements, let me start with you.
STATEMENT OF DR. JOSHUA M. SHARFSTEIN, PRINCIPAL DEPUTY
COMMISSIONER, FOOD AND DRUG ADMINISTRATION, ACCOMPANIED BY
DEBORAH M. AUTOR, DIRECTOR OF THE OFFICE OF COMPLIANCE, CENTER
FOR DRUG EVALUATION AND RESEARCH, FOOD AND DRUG ADMINISTRATION,
AND MICHAEL A. CHAPPELL, ACTING ASSOCIATE COMMISSIONER FOR
REGULATORY AFFAIRS, FOOD AND DRUG ADMINISTRATION
Dr. Sharfstein. Great. Mr. Chairman and members of the
committee, thank you for having this hearing. I am Joshua
Sharfstein, the Principal Deputy Commissioner of the U.S. Food
and Drug Administration. I am a pediatrician and I am the
former Health Commissioner of Baltimore, MD.
I want to talk to you about what happened at McNeil, what
FDA has done, and I want to answer your questions.
I am joined, as you mentioned, by Deb Autor, who is also a
former prosecutor at the Department of Justice and a finalist
for the Service to America medal; and by Mike Chappell, who is
a 38-year veteran of FDA.
The FDA has authority over drug manufacturing both to
enforce general good manufacturing practice requirements and to
require companies to comply with their own rules.
McNeil Consumer Healthcare makes a variety of over-the-
counter products for the U.S. market from four manufacturing
facilities in the United States and Canada. Over the last
several years, FDA has had growing concerns about the quality
of the company's manufacturing process, reflected in
unsatisfactory inspections and recalls. FDA inspected the
company's facilities with an increased frequency and, in
February 2010, the agency convened the management of its parent
company, Johnson & Johnson, to express concern about a pattern
of noncompliance. This is a story of an agency that identified
a problem, confronted a company, and eventually forced major
changes to protect the public.
I would now like to walk you through some of the key
events.
Prior to 2009, FDA investigators identified several
problems with good manufacturing practices at facilities run by
McNeil. These problems included laboratory controls, equipment
cleaning processes, and a failure to investigate identified
problems. The company generally fixed these problems and the
agency inspected the firm regularly.
At its Fort Washington facility, McNeil makes a wide
variety of over-the-counter products, including a large number
of over-the-counter liquid products for children.
In May and June 2009, FDA identified several violations,
including McNeil's failure to meet its own standard for quality
in one of its ingredients in over-the-counter liquids. McNeil's
standard for this ingredient, known as microcrystalline
cellulose, required that there be no gram negative bacteria.
McNeil purchased the cellulose in partial lots that had not
tested positive for this objectionable bacteria, but the vendor
had tested other partial lots from the same master lot and had
found a certain bacteria called Burkholderia cepacia. According
to its standards, McNeil should not have used any of the
partial lots from this master lot.
In reviewing the situation, FDA scientists at the time
concluded that the risk to the public was remote. All of the
drugs that were used had tested negative for the bacteria, all
the final product had tested negative, and FDA agreed with the
company's assessment that this bacteria would be very unlikely
to grow in the final product.
Yet, because the company had not kept to its standard, it
represented a significant violation of manufacturing processes
and the company initiated a recall of almost 8 million bottles
of finished product.
A few months later, in Puerto Rico, where McNeil makes a
large number of over-the-counter pills for the U.S. market, FDA
became aware that the company had received reports of products
from this facility having a musty odor. Yet, McNeil had not
fully investigated these reports for about a year and did not
notify FDA, despite the requirements that such reports be
referred to the agency within 3 days.
FDA inspectors urged McNeil to conduct a complete
investigation, which eventually identified the source of the
odor to be a chemical called TBA, which was in the air because
of a pesticide used on the wood of the pallets to store empty
medication bottles. McNeil initiated a series of recalls as the
scope of the problem became clear.
The risk to the public by this problem included potential
temporary non-serious reactions, including nausea, stomach
pain, vomiting, and possibly diarrhea. Very little is known
about this chemical called TBA, but in the small quantities
transferred to the products, it was not thought to pose a
serious risk for long-term health problems.
On January 15, 2010, FDA issued a warning letter expressing
serious concerns about the company's control over the quality
of its products and the company's failure to aggressively
investigate and correct quality problems. FDA noted in this
public warning letter that neither upper management at Johnson
& Johnson nor McNeil had assured timely investigation and
resolution of the issues.
On February 19, 2010, in the wake of that warning letter,
senior compliance staff from FDA's Center for Drug Evaluation
Research and the field organization called a meeting with
senior officials from McNeil and its parent company, Johnson &
Johnson. Attendees included the president of McNeil, the
company group chairman for over-the-counter drugs at Johnson &
Johnson, as well as a number of quality assurance executives
from both companies.
This was an extraordinary meeting. FDA requested that
senior officials from Johnson & Johnson attend the meeting over
the heads of the McNeil executives so that they would be on
notice regarding FDA's rising concerns about whether McNeil's
corporate culture supported a robust quality system to ensure
the purity, potency, and safety of its products. FDA raised
concerns about multiple recalls based on the recent inspections
and expressed concern that there was a pattern of failure to
report material information to FDA in a timely manner. FDA told
the company that significant immediate steps were needed to
address issues of compliance and quality.
We learned that the company was taking major steps to
address these issues, but we told them we would not take their
word for it; they would expect close oversight ongoing.
In April, FDA returned to McNeil's facility in Fort
Washington. This was an inspection that was scheduled sooner
than usual because of the history of compliance problems.
Days before the inspectors arrived, McNeil shut down
manufacturing because of particulates found in a number of
liquid medications, including acetaminophen, cellulose, nickel,
and chromium. We identified a range of violations, including
failure to meet its own specifications for bacteria and
particulates and, for one Tylenol product, the possibility of
higher than expected concentrations of Tylenol.
In reviewing the situation, FDA scientists concluded the
risk posed to the public by these problems was remote. We did
not find evidence that McNeil used raw materials that its tests
found to be positive for bacterial contamination and that all
finished lots tested negative. The particulates would be
expected to pass through the gastrointestinal tract. And while
there was a potential for higher concentrations of Tylenol per
dropper, none of the final products tested with high levels.
Although the public health risk from these quality problems
is low, these problems should never have occurred, and the
manufacturing failures at the facility that caused them were
unacceptable. Following requirements assures that products are
consistent in their safety and effectiveness, and failure to
follow these procedures risks more serious problems and
undermines consumer confidence.
On April 30th, McNeil announced a voluntary recall of over
136 million bottles of liquid infants' and children's products.
The agency is now closely monitoring the implementation of
a corrective action plan that includes changes to McNeil's
quality system, organizational changes, and senior management
oversight.
FDA will take steps to ensure that when this facility
begins to manufacture again, it will be able to produce safe
products. We are also considering additional enforcement
actions against the company, which may include seizure,
injunction, and criminal penalties.
I wanted just to say one word about adverse events. It is
understandable that many Americans, hearing about these large
recalls, are wondering whether or not their children were put
at risk. In assessing this question, FDA considers two sources
of information: first, our assessment of the manufacturing
problems themselves and, second, adverse event reports to the
agency.
As I discussed earlier, FDA analyzed the various
manufacturing problems. Based on the circumstances in each
case, our experts believed the risk for any child in the United
States was remote.
We also looked and are looking at adverse event reports
reported to the agency. We receive these reports and often
request and review medical records, coroner's reports, and
other supplementary data sources.
In one case we had a report of a 6-year-old child where the
child died as a result of an infection from Burkholderia
cepacia, the same bacteria that was found in the lot of the
ingredient. FDA actually got hold of the medications used by
this child and tested them, and we conducted extra inspections
to see whether there was a connection between this death and
the product. In fact, all the samples tested negative and FDA
believes that there was not a connection in that particular
case.
When we have adequate information, we review the reports to
determine what role, if any, the medication played in the
development of an adverse event. We can find the medication had
no role in the adverse event, that the activity as a drug could
cause a serious side effect, or that a quality problem may have
contributed to the outcome.
So far, FDA does recognize that some of the reports may
reflect the side effects of the medications, but we have no
cases with evidence that a product quality problem contributed
to a significant adverse health outcome for children. We are
continuing to receive information about certain cases and we
will update the public and the committee should our assessment
change.
Let me close by noting that every investigation presents an
opportunity for FDA to improve our effectiveness in protecting
public health. In this case, we have learned more about the
importance of corporate structure for compliance. When we do
not get a response that we are comfortable with from a
subsidiary, FDA will not hesitate, as we did not in this case,
to go over their heads to the corporate parent. FDA will be
developing new procedures to use what we learned at one
facility in guiding our inspections of other facilities run by
the same company.
We have also gained experience with two issues that we are
working on at the agency: how to improve our recall process and
how to strengthen enforcement. FDA Commissioner Dr. Margaret
Hamburg has called for FDA's enforcement to be vigilant,
strategic, quick, and visible. A range of activities are
underway at the agency to bring this vision to reality,
including strengthening our criminal enforcement of FDA's laws.
We will continue to work with Congress to secure additional
authority to assist us.
Let me just mention in this regard we believe that
transparency in our enforcement activities is very important,
both so people can see what we are doing and to make sure that
we are accountable. As part of our new program performance
effort at FDA, called FDA-TRACK, we are going to be posting
monthly the numbers of different kinds of enforcement actions
that FDA is taking, and as part of our transparency task force
we have proposed making public every inspection, when it is
happening and what the outcome of that inspection is, and we
are getting public comment on that.
I would end by saying that this episode reminds us that a
vigilant FDA is essential to drug safety in the United States.
FDA inspectors identified serious problems at McNeil, called
the company to account, and forced major changes to protect the
public. On behalf of the many FDA staff who worked on and are
continuing to work on this issue, I appreciate the opportunity
to make this statement and I look forward to your questions.
[The prepared statement of Dr. Sharfstein follows:]
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Chairman Towns. Thank you very much, Dr. Sharfstein, for
your statement. Let me just begin by saying this. Does the FDA
need more enforcement authority or funding to be able to
respond to issues like this recall?
Dr. Sharfstein. Thank you. I think that it is instructive
to think about the food safety bill a little bit, because in
the food safety bill there are some provisions that Congress is
looking at granting the FDA over food that we don't currently
have over drugs, and those include authority to require certain
types of quality systems and preventive controls, mandatory
recall authority, access to records by companies, and civil
money penalties.
So those are some areas where we don't have a position at
this point, it hasn't worked its way through the system. With
respect to drugs, I would point those out, that those are in
the food safety bill. The administration is supporting those
for foods.
Chairman Towns. Let me ask this. Can you say with complete
certainty that no children who took the medicines that were
recalled last month were harmed by them?
Dr. Sharfstein. No, I cannot say that with complete
certainty. I think we are continuing to get information and
there were remote risks that were potentially possible. But
from what we know, we do not have evidence at this point of
children who did have serious problems. But because there was a
remote risk, it was the right thing to do the recall.
Chairman Towns. But are you still looking to see in terms
of whether or not this occurred?
Dr. Sharfstein. That is correct, we are. And there are
certain reports that we have gotten that we are in the process
of thoroughly reviewing.
Chairman Towns. How serious were the problems at McNeil's
plant in Fort Washington that the FDA most recently discovered?
How serious were they?
Dr. Sharfstein. I think as manufacturing problems go, they
were serious. There was a range of different problems. They had
not responded to the complaints that they had gotten of
particulates in the product; they had missed the fact that some
of their ingredients came from a lot that had had
contamination, even though the previous year they knew this to
be an issue. There were a wide range of findings that indicated
to us that there were serious manufacturing quality problems at
the facility.
Chairman Towns. What went wrong that caused one of the
largest makers of children's medicine to recall millions? Was
it quality control? What do you think might have happened here?
Dr. Sharfstein. I think that is a great question and it can
be answered at different levels. I think one level you answer
it is exactly like you said, it is quality control, that there
were quality control problems. At another level you have to ask
why, why did a company with a reputation and record of McNeil
and Johnson & Johnson have those quality control problems?
And we think it is a very important question for you to be
looking at. It is something we need to understand better. We
think it may relate to the corporate compliance and corporate
structure. And we note that the company has made major changes
in that when we confronted them with the very serious
compliance problem that they were having.
Chairman Towns. Could you sort of describe to us what you
are doing now to work with Johnson & Johnson to make sure that
they correct the problems that exist?
Dr. Sharfstein. Sure. Well, this facility in Fort
Washington is now not manufacturing. There is a complete plan
for standing it back up that the company is going to be
presenting to FDA. I think it is fair to say that we have very
good cooperation from the company now; that they are really
looking for the agency's seal of approval before they get
going, and I am sure you will hear that from them on the next
panel. In addition to what we are working on there, we are also
reviewing the record and considering whether other types of
enforcement action are appropriate.
Chairman Towns. Dr. Sharfstein, tell me what the FDA
believes McNeil did as described in these FDA documents that we
received.
Dr. Sharfstein. Can you say that again? I am sorry.
Chairman Towns. On the screen there, Doctor.
Dr. Sharfstein. Oh, I see.
Chairman Towns. On the screen.
Dr. Sharfstein. What do we believe actually happened here?
Chairman Towns. Yes.
Dr. Sharfstein. This is something that is troubling to the
agency. I am not sure we know the complete full story, but
basically there was a problem with how Motrin tablets dissolve
and whether or not patients would get the right dose. The
company notified FDA that they were going to be evaluating
whether there was product on the shelves to recall.
Then we were alerted, I believe, by one of the State Boards
of Pharmacy that instead of just looking to see whether or not
there was medication to recall, the company had a contractor
that was going out and trying to buy up all the medicine when
they went into the store, and the information said you should
simply act like a regular customer while making these
purchases, there must be no mention of this being a recall of
the product. If asked, simply state your employer is checking
the distribution chain of this product and he needs to have
some of it purchased for the project.
I don't think we really fully understood exactly what was
going on. It was troubling to us and, when FDA found out about
this, we insisted that an actual recall occur. And we did think
that it reflected poorly on the company, and it was one of the
things that FDA brought to their attention during this
extraordinary meeting that happened in February.
Chairman Towns. Thank you. After the recall, FDA
recommended consumers buy drugstore alternatives for their
children. The vast majority of those drugstore products are
made by Perrigo, a company in Michigan that had ongoing quality
control problems. When was the last time FDA inspected the
plant in Michigan that makes infants' and children's problems?
Do you know when it was inspected last?
Dr. Sharfstein. I do. I may ask Deb Autor to answer that
because she oversees the compliance efforts at the Center for
Drugs. I believe there were several inspections in the last
couple years.
Ms. Autor. I don't have the exact dates here, but there
have been several inspections in the last few years. I believe
there have been two in 2010, but I would have to double-check
those facts.
Chairman Towns. But you agree with the fact there have been
some issues with quality control?
Ms. Autor. Yes, there have been some issues at Perrigo.
Chairman Towns. OK, on that note, I yield to the ranking
member for 5 minutes.
Mr. Issa. Thank you.
Ms. Autor, I would like to followup. Is it appropriate for
the FDA to recommend an alternative at all? Basically, if you
say don't do that or, baby doctor, if you prefer, isn't it
really appropriate for the FDA to simply deal with its knitting
and say don't take that, and not intervene in alternatives?
Dr. Sharfstein. Well, the challenge is----
Mr. Issa. I know there is an irresistible urge to answer
people's questions; I am in that business. But isn't it in fact
inappropriate for any government entity to make a
recommendation unless it is an authorized recommendation? It
doesn't appear as though there is any mandate for that.
Dr. Sharfstein. I think that Dr. Hamburg and I see FDA as a
public health agency that has to be responsive to the needs of
clinicians and patients, and it very frequently happens that
there is a shortage of one medication, and we have a whole
shortage team that works with manufacturers and professional
societies to give recommendations in the event of a shortage
for what can be used as an alternative. I think it is wrong to
say this brand is the right one to use, but when people don't
know what is available, for the FDA to say we want you to know
this medication is available and is a potential alternative, I
think that is information that the clinical community really
wants to hear from FDA.
Mr. Issa. And I have no problem with the clinical
community. When you speak doctors to doctors, I certainly
appreciate that. My only question was where is the line. I
think all of us want to know where is the line when it is
ultimately to the public, to the uninformed public. As you
said, a brand name would be inappropriate, but a chemical
description, I gather, is what you are saying would be
appropriate, which would cover potentially multiple brands?
Dr. Sharfstein. Right.
Mr. Issa. OK.
Ms. Autor, one that I know falls more squarely on you, in
this case, I don't want you to say you have an investigation or
you don't, but is there a potential criminal liability for some
of the acts that went on?
Ms. Autor. I think what I can say at this point is that the
Center for Drugs has referred this to FDA's criminal
investigative unit, and then they have to judge where to go
from there.
Mr. Issa. OK. I will take that as a yes, that there is at
least the potential, and that everyone who is out there
providing food and drugs should be aware that the scenario we
just saw in the future, or perhaps in this case, could lead to
criminal actions or indictments. At least not saying in this
case, but that should be fair warning to people who are
watching this hearing.
Ms. Autor. And I think, as Dr. Sharfstein said, the agency
is working to increase our enforcement on the criminal side and
to connect carefully what we do on the criminal side with what
we do on the civil side so that we can maximize the
effectiveness of those tools.
Mr. Issa. Yes, Doctor.
Dr. Sharfstein. I think that is an excellent point. We very
much want to send that message. Dr. Hamburg, the Commissioner,
gave a major address on enforcement, where she called on
companies to make sure they had excellent compliance programs,
and just this week someone sent me an email about a course and
report that is being marketed, where it says bigger, tougher,
faster, preparing for the new FDA. When the inspector comes
calling, will you be ready?
And it is all about sending a message to industry. This is
within industry they are marketing this, that FDA is
significantly strengthening its oversight and companies have to
learn how to put quality systems in place. This is the kind of
thing we like to see. We don't like to see these kinds of
recalls; we like to see compliance. That is our goal. And
seeing the industry really coming together, getting the
message, that is very important to us.
Mr. Issa. Now, Doctor, your being here today goes far
beyond the McNeil division of Johnson & Johnson, so let me ask
a slightly different question. In the ordinary course, you try
to visit facilities here in the United States once every 2
years. But, more and more, non-prescription drugs are being
produced in China and other very far away places, and those
places, in many cases, have a standard of simply lying on their
paperwork. We have had that in a number of other areas.
How do you propose that the FDA be able to ensure that a
foreign manufacturer in a country where we have a fairly opaque
ability to go beyond what the papers presented at the factory,
that we can rely on those test results and, as such, the
medicine that comes from them?
Dr. Sharfstein. It is an excellent question. The safety of
imports is extremely important to us, and Dr. Hamburg has
raised these very similar sorts of concerns in some major
speeches, and we had a hearing in the Energy and Commerce
Subcommittee on health not too long ago, where this got a fair
amount of attention. It is a concern for us and there are
certain things that we need to be able to do better. Included
among those is holding each person in the supply chain
accountable, and there are some tools that would allow us to do
that. In addition, we need to significantly expand our
coordination with other agencies.
We now have two foreign offices in China that coordinate
with other agencies. For example, if Australia does an
inspection that we have confidence in, then we can go to
another plant in Australia and can have confidence in that
inspection. We also need to strengthen and work----
Mr. Issa. So what you are saying is part of your procedure
would be to learn to inspect the inspectors, to qualify
countries or inspection techniques so that we can be somewhat
reciprocal.
Dr. Sharfstein. That is absolutely true both for our major
partners in the developed world, but also we want to strengthen
the indigenous inspecting capacity, and there is a big effort
to do that in countries like China and India. So it is a very
complex problem and there are a lot of solutions.
Mr. Issa. Let me just ask one final question. And if it
goes long, I would ask that it be answered for the record.
Every day, 45-foot, 53-foot containers of non-prescription
drugs come in the country. Currently, our import authorities
open only a fraction of those containers and, when they do,
they open them to see if it is an aspirin, and not much more.
Do you believe here today that the Congress should begin
creating both the authority and the mandate for at least sample
inspection of 100 percent of these types of imports if they
come from countries that you have not certified the certifiers?
Dr. Sharfstein. I believe that Congress and the FDA need to
work together to really address the question of import safety.
I am not sure 100 percent testing is the answer. I think we
need to have 100 percent accountability across the supply chain
and a strong import border presence, but it has to be addressed
comprehensively.
Mr. Issa. OK. I would like you to answer for the record,
then, the key question of if it comes from a country in which
you have not achieved that level of confidence, no part of the
supply chain can change the fact that if any one of those
bottles is bad and there has been no sampling, you will not
have that public confidence.
So I would like you to tell us how you are going to get
that confidence if you didn't get it in the country of origin
and now it is sitting in a container in the United States or
going through the supply chain. And I ask you to answer that
for the record.
Dr. Sharfstein. Happy to do that.
Mr. Issa. Thank you.
Thank you, Mr. Chairman.
Chairman Towns. The gentleman's time has expired.
I now yield 5 minutes to the gentleman from Maryland, Mr.
Cummings.
Mr. Cummings. Thank you very much, Mr. Chairman.
Dr. Sharfstein, it is very good to see you again. And I say
this without reservation: When you served as the Health
Commissioner for Baltimore, where I live, you did an
outstanding job. You did it with excellence and integrity. And
I have full faith and confidence in you. So I wanted to say
that before I got into these questions.
Dr. Sharfstein. OK. Thank you.
Mr. Cummings. There appears, Dr. Sharfstein, as I listen to
your testimony, that McNeil was involved in a culture of
mediocrity. It seems that the FDA had one standard and McNeil
had another, and I am trying to figure out where the two meet.
In other words, it sounds like the standard at McNeil, they
said, OK, we got a little taint here, a little problem there,
but we will still mix it up, it will be all right. FDA says,
no, that is not good enough. And then you said something that
was very interesting. You said there might be a need to take
further action. You said further action may be required.
I am trying to figure out how that all comes together. When
you have a company that seems to be, over and over again, be it
by negligence, intent, greed, or whatever, skirting the system,
but you have the FDA saying we have this standard, how does
that work? How does that come together? You follow what I am
saying?
Dr. Sharfstein. Sure. Absolutely. And there is a real
parallel to Baltimore because in Baltimore we inspected
restaurants at the Health Department, and we would sometimes
find problems, and there is always a balance between
cooperation, working cooperatively with the business, and
taking action; and most of the time we would find a problem and
the business would jump and fix it, and then we were done.
But every so often there was a restaurant that we would
have a significant problem with and we eventually got to the
point where, for some people, we took away their license to run
a restaurant in Baltimore, their ability to do that. It is a
balance.
And I think if you look at this experience with McNeil, you
see that. FDA is pointing things out, McNeil is sort of
correcting them, waiting a little bit of time in some cases to
tell us about problems, and over time FDA is ratcheting up the
oversight like we would do in Baltimore, where we would say,
wait a second, this should have been corrected in a restaurant,
and we are going to have to go back again, and eventually we
are going to have to bring them in and eventually we are going
to bring them to the administrative judge. That is basically
what FDA is doing.
And the story of this whole episode is that FDA increased
the pressure, brought in the corporate executives and wound up
forcing, I think you will hear, very major changes in the
company's approach to quality.
We are going to use this as an opportunity to see what we
can improve. But I think overall it is a tough balance that the
FDA has to strike.
Mr. Cummings. Let me ask you this. In your testimony you
state that in February 2010 FDA took the extraordinary step,
you said, of meeting with the management of Johnson & Johnson
to express your concern about a pattern of noncompliance. Why
was this meeting considered so extraordinary?
Dr. Sharfstein. What was extraordinary about it were two
things. First of all, we went over the heads of the whole
company. McNeil is a pretty big company, but we went to the
actual corporate central head of the entire major company to
express this concern. That is one reason why it is
extraordinary.
The second thing is usually we meet about specific
problems, and this was a meeting about a culture of compliance,
that we had seen so many problems at different facilities, and
problems that really concerned us, that we really were calling
them on their whole quality system, and it led to major
changes, I think you will hear, at the company. People were
moved in their positions or removed from their position. They
have a whole new layer, I believe you will hear. And I think
those were the two things that made it extraordinary, that we
went over their heads and that we talked about the culture of
compliance at the company, not just individual problems.
Mr. Cummings. Now, how did Johnson & Johnson react to what
you said? They were present at the meeting, were they not?
Dr. Sharfstein. They were, yes.
Mr. Cummings. OK. What was their reaction?
Dr. Sharfstein. My understanding is they took it quite
seriously. They heard that this was not a usual kind of meeting
for the FDA to have. They had gotten one of the fastest warning
letters ever from what happened in Puerto Rico. We issued a
warning letter and the warning letter itself mentioned the fact
that there was a failure of oversight by not just McNeil and
Johnson & Johnson. And I think, based on the changes they
committed to at that point, we got the sense that they had
heard our concern, although we made it very clear that we
weren't going to take their word for it.
Mr. Cummings. And what does all of this say about a
corporation? Apparently, you have gone pretty far with this
corporation. What does this say about this corporation? Have
you drawn a conclusion?
Dr. Sharfstein. Well, you know, most of the companies that
FDA deals with do comply, and there are some great examples out
there of terrific compliance programs. This is a company that
had a major problem with compliance, and it was a problem that
crossed different domains, different facilities, and was a
systematic problem at the company. That is something FDA needs
to be able to identify and address with the company, with its
senior leadership, and we have to be willing, and I think in
this case I think we did, really, call them to account for it.
Mr. Cummings. Thank you, Mr. Chairman.
Chairman Towns. Thank you. Thank you very much.
I now yield 5 minutes to the gentleman from Utah, Mr.
Chaffetz.
Mr. Chaffetz. Thank you.
Thank you all for being here. In a moment, Ms. Goggins,
from Johnson & Johnson, is about to testify, and in her written
testimony she says, ``The health risks due to consumers from
the recalled products were remote.'' Is that true or false,
from your opinion?
Dr. Sharfstein. I think that is also FDA's understanding
right now.
Mr. Chaffetz. Next thing she says, ``Second, McNeil has no
indication of a serious adverse medical event caused by any of
the issues referenced in the recalled announcement.'' In your
opinion, is that accurate?
Dr. Sharfstein. Well, I can't speak to what McNeil knows.
FDA does not have evidence of that kind of severe event,
although we are continuing to investigate certain cases.
Mr. Chaffetz. She says, ``Third, no raw materials that
tested positive for objectionable bacteria were ever used in
the manufacture of McNeil's pediatric products.'' Is that true?
Dr. Sharfstein. I would say that is sort of true, maybe
with an asterisk.
Mr. Chaffetz. Sort of true?
Dr. Sharfstein. Yes. I would say----
Mr. Chaffetz. What is sort of true?
Dr. Sharfstein. You know, with a footnote, the footnote
being they did use raw materials from lots that had tested
positive. There were some negative tests for the parts of those
lots that they used, but FDA does not consider that an adequate
assurance of safety.
Mr. Chaffetz. ``And, finally, McNeil rejected the products
that it found had excess active ingredient.'' Would you agree
with that statement or disagree with that statement?
Dr. Sharfstein. Again, I would say I agree with a footnote.
When they knew those particular lots had excess ingredients,
they rejected it. But I think we felt that they didn't test
other parts of that area to be sure that there wasn't a
problem, another ingredient that was shipped.
Mr. Chaffetz. Now, my understanding is----
Dr. Sharfstein. Let me just see if Deb wants to clarify
that?
Ms. Autor. Yes. Just to clarify that, with the potency
issue, what happened was that McNeil made a change in their
manufacturing process, the size of the vat they were using,
without testing whether the product would adequately mix once
that change was made. So they produced 11 batches using that
new process.
Three of them tested to be super-potent. They threw away
those three, but, from our perspective, there is no assurance
that the other eight wouldn't have the same potency issues.
They did some testing, they didn't find potency, but, because
the process hadn't been tested, there was potential that there
were potency problems in the other batches even though they
hadn't tested that way.
Mr. Chaffetz. I appreciate the efforts of the FDA and I
love the fact that they are ahead of the ball, but having found
no serious adverse reaction, is the FDA overreacting to this? I
mean, there are 775 serious side effects, so where in the
spectrum is this in what you are usually dealing with? How
severe is this problem?
Dr. Sharfstein. Well, let me answer that in a couple ways.
The side effects were reported about the medications, and we
think that some of them were linked to the actual medications
used, not the quality problems. And I think the number of
adverse events we probably have to separate a little bit from
the quality problems.
We consider these quality problems to be quite significant,
and we want to fix them before it becomes a point where we are
counting the problem in hospitalizations and injuries, instead
of in bottles recalled.
Mr. Chaffetz. What is a mom supposed to do? You have had
hundreds of millions of products recalled. How many of those
have actually made it beyond the store shelf and actually into
somebody's cupboard and they are sitting the? What is a mom
supposed to do at home?
Dr. Sharfstein. We had some in our house. I think we
recommend that people throw out the ones that they have. You
can find out which ones they are from the Web site and other
information, and that they can go to the store and get
alternatives.
Mr. Chaffetz. So if you have any of these products on your
shelf, you are supposed to actually go back to the store? When
you say the Web site, how does that work? Is there a lot number
on the bottom that they can go check on the FDA Web site?
Dr. Sharfstein. There is, yes. McNeil has actually set up a
phone number for people to call to get instructions. They may
answer better how they are handling that part of it, but there
are instructions for people to be able to turn back their
medication.
Mr. Chaffetz. And, finally, were any of you at those
meetings in February?
Dr. Sharfstein. I think that Ms. Autor was the one who
called for the meeting, but I don't think any of us were at the
meeting.
Mr. Chaffetz. OK.
All right, thank you, Mr. Chairman. Yield back.
Chairman Towns. Thank you very much.
I now yield 5 minutes to the gentleman from Ohio, Mr.
Kucinich.
Mr. Kucinich. Thank you.
Dr. Sharfstein, in your testimony you reference a 2010
report which identified a 6-year-old child who died. Now, prior
to the child's death, according to this report, the child had
been given several products manufactured at the facilities in
question. Did any of those products that the child took contain
a harmful bacteria?
Dr. Sharfstein. No, as far as we know. Those were tested,
and we did not see any of the bacteria.
Mr. Kucinich. And what was the cause of death?
Dr. Sharfstein. I want to be sure whether we have this. I
think there that is still an open coroner's investigation, so I
am not sure they have a final cause of death. It may have been
infection.
Mr. Kucinich. When was the death?
Dr. Sharfstein. January.
Mr. Kucinich. Have you seen an toxicology screens from this
autopsy report? Have you seen the autopsy report?
Dr. Sharfstein. I am not sure that we have the final
autopsy report. If the coroner's investigation is open, we
probably don't have the final report. I understand that there
was this bacteria found in multiple tissues.
Mr. Kucinich. Which bacteria was found in multiple tissues?
Dr. Sharfstein. Burkholderia cepacia.
Mr. Kucinich. And was that bacteria found in any of the
samples that the FDA picked up of the products that were
recalled?
Dr. Sharfstein. No. No. That bacteria was not found in the
products that this child apparently consumed; it was not found
in any finished product that we know of. But it was the same
bacteria that was involved in the ingredient issue that the
company had.
Mr. Kucinich. So does the FDA have a pathologist on its
staff?
Dr. Sharfstein. I couldn't tell you 100 percent.
Mr. Kucinich. Do you outsource pathology reviews?
Dr. Sharfstein. Well, we do have medical officers who would
be qualified to review pathology reports.
Mr. Kucinich. Are they certified in terms of pathology? Are
they pathologists or do they just review pathology reports?
Dr. Sharfstein. I would have to get back to you on that
exact question. But we do have people who are qualified to
review pathology and judge whether or not we are concerned
about a link between a product and a particular death.
Mr. Kucinich. Why was the report even included in testimony
if it doesn't seem to rise to the level of significance,
according to your answers here?
Dr. Sharfstein. Well, I used it as an example of how
seriously we take reports like this. I mean, we went out, we
tested the products. We actually went back and reviewed the
records again at each of the facilities that were involved,
because they had taken products from the two facilities. It is
really two lines of evidence that we use: one is our assessment
of the manufacturing problem and the other is a thorough
investigation of the adverse event reports that we get, and
that was an example of one.
Mr. Kucinich. When is something, by your consideration, the
result of an adverse event that is well understood to be a
contraindication of taking of a drug and, on the other hand, an
adulterated product? How do you make the distinction?
Dr. Sharfstein. It is a good question. It partly depends on
the specific situation. So, for example, in some of the cases
that were reported, there were toxic levels of the medicine, a
variety of medicines, and there was a history of the child
maybe getting extra doses. That is a known problem for certain
over-the-counter medicines.
Mr. Kucinich. When will you get the autopsy report on this
6-year-old child who died? Do you expect to get it?
Dr. Sharfstein. Will we? Oh, yes, I believe so.
Mr. Kucinich. Can you share it with this committee?
Dr. Sharfstein. I am sure we would do that, yes.
Mr. Kucinich. And could I ask you, to your knowledge, does
anyone who is at the FDA, have they ever gone over and worked
for Johnson & Johnson or McNeil? Is there anybody over there at
Johnson & Johnson or McNeil who used to work for the FDA?
Dr. Sharfstein. I couldn't say for sure, but I would guess
probably there are people who have.
Mr. Kucinich. And is there anyone who used to work at
Johnson & Johnson or McNeil who now works for the FDA?
Dr. Sharfstein. I don't know that for sure, but it is
possible.
Mr. Kucinich. OK.
Thank you, Mr. Chairman. No further questions.
Chairman Towns. Thank you. Thank you very much.
I now yield 5 minutes to the gentleman from Ohio, Mr.
Jordan.
Mr. Jordan. Thank you, Mr. Chairman.
I want to thank you all for being here with us today.
Just to be clear for the record and kind of picking up
where Mr. Chaffetz was, the cause and effect, has there been
any determination that any adverse event was caused by product
from McNeil or Johnson & Johnson?
Dr. Sharfstein. By the product, not the product quality
issue? Yes, I believe that there are adverse events that are
known to be caused by the product. There are a lot of adverse
events that happen in medicine, and often they are linked to
the actual pharmaceutical itself because all medicines have
risks and benefits. But not anything linked to the product
quality issues that we are talking about here.
Mr. Jordan. OK. I just wanted to be clear on that. Have you
looked at any of the recalled product? Have you tested that to
see if there is the bad stuff in there, any of the product that
has been taken off the shelf?
Dr. Sharfstein. We did in the course of some of these
investigations of individual adverse events, but generally,
other than that, we generally don't do that.
Mr. Jordan. And why not? I mean, in this situation why not?
Dr. Sharfstein. Well, we believe that if there needs to be
a recall because of the testing that has been done demonstrates
a problem, then it should just be recalled, there is no need
for us to do it.
Mr. Jordan. No need to check it out? OK. If I follow the
time line right, you did the warning letter in January, you had
the inspection of the Pennsylvania facility, I believe, in
April, and then you have had the recalls and the stoppages and
everything else. And you had the meeting where it seemed like
you indicated at that meeting, though you all weren't there,
that you felt that it was positive and productive.
I mean, I contrast what we are hearing about here and what
we have seen with, frankly, what we are hearing about in the
Gulf Coast with MMS, I guess it is, the Mineral Management
Service, and their relationship with the industry. It seems to
me this process is working much better than what we are seeing
and hearing about in another area of government. Do you think
the process is working appropriately?
Dr. Sharfstein. I think, as I testified, if you look at
what happened here, you had a team, actually both part of Mr.
Chappell's organization and Ms. Autor's organization, career
inspectors that at FDA who are very vigilant with this company,
identified the problem, called them to account, and it led to
major changes to protect the public.
Mr. Jordan. OK. OK.
Mr. Chairman, I yield back. Thank you.
Chairman Towns. I thank the gentleman for yielding back.
I now yield to the gentlewoman from Washington, DC, Ms.
Eleanor Holmes Norton, 5 minutes.
Ms. Norton. Thank you very much, Mr. Chairman.
Dr. Sharfstein, listening to your testimony and the action
taken, I want to commend you for what looks like effective
action by an administrative agency. I would like to ask you
about this notion of super-potency. I think about when my kids
were young. If I had read that something I was giving them was
found by FDA to have something called super-potency, I would
have been immediately fearful. I would like to know what it
takes for a product to be super-potent, and as a physician,
former Public Health Commissioner, whether you think such
potency could result in health effects at some later point.
What does it mean?
Dr. Sharfstein. Sure.
Ms. Norton. How did it manifest itself?
Dr. Sharfstein. It is an excellent question. There is a
range of the amount of material in a drug that we expect to be
in a particular dose, and in this case I think it was up to
about 108 percent we expect to be there. And when they tested
certain lots, they found up to 124 percent of what they were
expecting. So let's say there is supposed to be 100 milligrams
in there. Any particular lot we would say it is acceptable, it
doesn't have to be exactly milligrams, it could be up to 108.
But what they found was up to 124. Now, they threw out those
lots, but we weren't assured that some of the ones that did
ship were OK because of what Ms. Autor said about their new
process.
So what happened was, both at FDA and at the company, we
looked, we assessed whether or not this problem, if it had been
there--we don't have proof that anything shipped that was
super-potent, but if it had been there, would that have posed a
risk; and that evaluation was done by physicians within FDA and
by doctors within McNeil, and for a number of reasons the
conclusion was this would not have posed a risk.
It is a relatively small increase; it was one formulation,
actually, of the dropper for little babies. And Tylenol and
acetaminophen is actually something that, particularly in
adults, you can get into trouble and people get liver problems
if they get overdoses on. But there are a number of reasons
why, for babies, actually, babies are much less likely to get
that problem, and it turns out it has to do with the way that
the chemicals metabolize in children's livers.
So that gives you one margin of safety, and then you have a
whole other margin of safety because 20 percent isn't a real
big increase in the scheme of toxicology that you are looking
for two or three times the dose to start to get into trouble.
So, for all those reasons we felt that the risk was very, very
low of a problem.
Ms. Norton. That is comforting, particularly since we know
adults get in trouble with these medicines in adult doses, and
we know these effects can be different. I have to ask you,
though, as a physician, these medicines for children and
infants are very controversial. I am looking at an ad for one
of them, and it says infant's, pediatricians' choice. Are these
effective enough to take the risk? Every time a child has a
sniffle, we ought to run for one of these infant doses of
medicines that weren't even available until fairly recently?
Dr. Sharfstein. Well, I think for particularly small babies
it is important for patients to talk with their doctors about
the use of medications. Congressman Cummings knows that I
personally have a history with some of these products of
concern, about whether they should be used for young children,
and I petitioned the agency, as the Health Commissioner of
Baltimore, about them, and I am recused from that issue at FDA
now. But I do think that it is important for patients to talk
to a doctor about the use of medicines. I certainly use Tylenol
and ibuprofen, acetaminophen for children.
Ms. Norton. For infants?
Dr. Sharfstein. For infants under certain circumstances.
But it really is something that, as a doctor, I would say,
particularly to parents of small babies, that it is very
important that we be in touch. If you are giving medicine
because you are worried about your child, I would say I want to
know about it so we can decide whether that was the right
response.
Ms. Norton. Dr. Sharfstein, let me ask you about a
statement in your statement. I am looking at page 10. You say
FDA is considering additional enforcement actions against the
company for its pattern of noncompliance, which may include
seizure, injunction, and criminal penalties. These are nuclear
penalties. Does FDA need more effective penalties? I don't
think you are going to go around seizing companies, or even
seizing large batches, and I don't think you are going to be
quick to run to court to get injunctions. And we have not seen
criminal penalties yet. Do you have the graduation of penalties
necessary to be effective here beyond the effectiveness you
have already shown?
Dr. Sharfstein. I think that is a very fair question to
ask. I will point out that in the food safety bill Congress is
looking at giving FDA the ability to assess civil money
penalties, which would be one of those graduated steps.
Ms. Norton. So you have no such authority now?
Dr. Sharfstein. I believe not.
Ms. Autor. Not for drugs, no.
Ms. Norton. That is authority you would like to have?
Dr. Sharfstein. You know, that position is sort of working
its way through the process, but the administration supports
that for food.
Chairman Towns. The gentlewoman's time has expired.
Before I go on, I just want to clear up something, Dr.
Sharfstein. When my staff and the ranking member's staff,
earlier this week, they were told that the recall consisted of
6 million bottles. I believe you said 136 million bottles? What
number are we using here?
Dr. Sharfstein. I understand that there was a recall of
about 6 to 8 million bottles last year, in 2009. That was the
2009 recall. But this recall was much bigger, over 100 million
bottles. That is my understanding.
Ms. Autor. This recall was over 136 million bottles. The
recall last year relating to the chemical contamination that
Dr. Sharfstein mentioned, by our numbers, was over 60 million;
and then the year before, the recall relating to the
potentially contaminated raw material was 8 million bottles.
Dr. Sharfstein. That wasn't the year before, it was a
couple months before.
Ms. Autor. Yes, I am sorry, a couple months before, in
August 2009.
Chairman Towns. Thank you very much for correcting the
record.
I now yield 5 minutes to Mr. Luetkemeyer of Missouri.
Mr. Luetkemeyer. Thank you, Mr. Chairman.
As I have been listening to the discussion this morning, it
seems to me that we have a situation where we have gone through
this and we had a 6-year-old that passed away, but it wasn't
necessarily due to the drugs that were in question here today.
Your own FDA report indicates that the recalled drugs pose a
remote potential problem for serious health problems, but yet
McNeil found their own problems. One of your comments a while
ago, Doctor, indicated that the operations were not up to
McNeil's standards. Can you elaborate on that just a little
bit? They have their own set of standards and you have FDA
standards?
Dr. Sharfstein. That is correct.
Mr. Luetkemeyer. Are their standards higher than your
standards or lower than your standards?
Dr. Sharfstein. Well, part of what good manufacturing
practices are is that a company has to set its own standards.
So that is something every company has to do.
Mr. Luetkemeyer. Are they higher than FDA standards or
lower than FDA standards?
Dr. Sharfstein. Well, part of FDA's standards is for the
company to sort of work together. So part of FDA's standards
are for the company to set standards for its product.
Mr. Luetkemeyer. OK. So it seems as though we have a
problem here. McNeil, correct me if I am wrong, they did the
recall on their own, is that correct?
Dr. Sharfstein. That is correct. We do not have mandatory
recall authority.
Mr. Luetkemeyer. So they found the problem, they realized
they had a problem, and they went out and did the recall on
their own. So it would appear to me that we have a situation
where it looks like we have a sloppy shop that found they were
doing poor work, and they are going to try to correct it
themselves, and you are working with them to do that, is that
correct? Is that pretty well framing it?
Dr. Sharfstein. I think that is basically true. I think
that what was particularly troubling in this story to FDA is
that there was a pattern of FDA finding out about things late.
People were complaining that the products smelled bad for a
year before they told FDA about it, and it turned out there was
a chemical coming in through the pallet. And it should not have
taken a year, it should have taken 3 days for us to hear about
it.
And the recall in 2010, part of that recall was related to
something that happened in 2009 that the company should have
been able to figure out. So I do think that, particularly over
this period, I believe that the company has gotten the message
from FDA and I believe that they are really improving, and I
think you will hear about that. But I do believe FDA's
oversight was very important to that.
Mr. Luetkemeyer. Have you found any problem with co-dosing
or taking more than the prescribed amount with the people that
you have had complaints with? Has that been a problem at all
with regards to some of the drugs you looked into with this
group?
Dr. Sharfstein. Well, these are over-the-counter, so they
are generally not prescribed. I do think, in general, for these
types of medicines, you know, overdosages are just generally an
issue, but nothing that I know for this that would make it a
particular issue.
Mr. Luetkemeyer. OK. But my question is, as you are looking
at some of the adverse events that you were describing here,
are in those events any instances of co-dosing? Are there
instances of over----
Dr. Sharfstein. Oh, absolutely. Yes.
Mr. Luetkemeyer. OK. Are those things, then, that are part
of whenever you get your little labeling and you get your
little pamphlet that goes along with your drugs, is that
information in there? Because these are over-the-counter drugs,
an individual has to read it themselves to be able to see that
they are not going to interact with something inappropriately.
Is that information there? Were these drugs something that were
not part of the prescription that was released along with the
drug itself?
Dr. Sharfstein. No, I think that, in general, the drugs are
labeled with their ingredients, and people should be able to
see those. It is complicated for some of these products because
they may have multiple ingredients and people may not
immediately realize that if they are giving one medication and
another, that they actually have the same underlying
ingredients; and that kind of confusion has been one of the
issues in this field, and I think it is something that FDA is
working with the industry on.
Mr. Luetkemeyer. So you are looking at further labeling or
further advertisement about this?
Dr. Sharfstein. You know, I probably shouldn't go further,
because this is the area that I am recused from, in part,
because of the petition that I wrote when I was the Baltimore
City Health Commissioner. But FDA is looking at the labeling
and the appropriate handling of this class of medicines in the
cough and cold arena.
Mr. Luetkemeyer. OK, with these adverse events, were any of
them with regards to taking more than the prescribed amount of
this medication?
Dr. Sharfstein. More than the labeled amount? I believe
yes.
Mr. Luetkemeyer. OK. So between the two of them, co-dosing
and taking more than suggested, what percentage of the total
number of adverse events would you apply to those different
groups?
Dr. Sharfstein. I would have to get back to you on that, I
couldn't answer that.
Mr. Luetkemeyer. I see my time has expired. Thank you, Mr.
Chairman.
Chairman Towns. Thank you very much.
I now yield 5 minutes to the gentleman from Virginia, Mr.
Connolly.
Mr. Connolly. I thank the Chair and I certainly welcome all
of the concerns of members of the committee about this tragedy.
It is too bad not everybody on the committee could find their
way to voting to give FDA mandatory recall authority, and that
is, I think, the crux of what we are talking about here today.
Mr. Chairman, this committee has held many important and
groundbreaking hearings in its history, none more important
than this. Why? Because 37 children are dead due to a tainted
product, a product that parents relied on; a product they
trusted to be safe both because of the brand name and the
expectation that the FDA ensured its safety through Federal
regulatory and oversight statutes. Whoever is responsible,
everyone involved failed those 37 families in a profound and
tragic way, including us.
This story is part of a much broader and equally tragic
pattern characterized by anti-government rhetoric, laissez-
faire laws and policies, and deliberate non or lax enforcement
of existing laws and regulations, especially during the Bush
administration.
In the last 6 weeks we have witnessed the unfolding drama
of multiple examples of the effects and consequences of this
laissez-faire philosophy of government:
A mine tragedy in West Virginia, with a number of deaths,
and one prominent advocate of the laissez-faire approach
actually reacting by stating sometimes accidents happen, even
though there is strong evidence lax mine safety enforcement had
something to do with that tragedy.
The BP oil well, which has spilled at least four times the
oil leaked in Exxon Valdez, was exempted from regulation by the
Minerals Management Service from the normal National
Environmental Policy Act regulations. Result: an oil slick the
size of Rhode Island and Delaware combined, threatening the
single largest fishery and source of seafood in the United
States.
No need for health insurance reform? Tell that to the
breast cancer victims who were systematically targeted by the
largest insurer in the United States for recision of all
coverage.
And what could go wrong with lax enforcement of oversight
on Wall Street? The steepest recession in 80 years, 8.5 million
Americans losing their jobs, the largest Government bailout in
American history, and the loss of $17.5 trillion, that is
trillion with a T, worth of aggregate worth in the United
States.
And now 37 children dead because a contaminated product
could not be detected and mandatorily recalled by the
regulatory agency in question in a timely fashion.
There is certainly a difference between these two
philosophies of government. One offers protections to the
public through reasonable regulation and strict oversight
enforcement, and the other leads us tragically, as we have seen
in these last few weeks, to nothing short of the law of the
jungle.
I yield back.
[The prepared statement of Hon. Gerald E. Connolly
follows:]
[GRAPHIC] [TIFF OMITTED] T3140.021
[GRAPHIC] [TIFF OMITTED] T3140.022
Chairman Towns. I thank the gentleman for his statement.
I now yield to the gentleman from Georgia, Mr.
Westmoreland.
Mr. Westmoreland. Thank you, Mr. Chairman.
Dr. Sharfstein, I have seven grandchildren and they spend
the night with us on a regular basis, so we have a cabinet full
of children's medicine; and my wife and I, after the recall,
went and looked and saw that some of it needed to be taken out.
Could you tell me who manufactures the CVS brand infant similar
medicine or maybe the Wal-Mart equivalent brand?
Dr. Sharfstein. I don't know if I can tell you off the top
of my head. I think that there may be a number of manufacturers
there. One of them was mentioned earlier that does supply for
that market, but there may be more than one.
Mr. Westmoreland. Because I know that a lot of times
certain companies make all the products and just put different
labels on them or have different specs. So you don't know who
actually? Since McNeil manufactures or at least has about a 70
percent market share, would we be safe going to buy a CVS or a
Wal-Mart, not actually knowing who manufactured it? I mean, do
you know that?
Dr. Sharfstein. Well, FDA knows who manufactured it, I just
don't know off the top of my head. But I think one of the
things we were talking about is that FDA does inspect those
facilities too, and FDA has not identified the kinds of
problems at those facilities, and that is why they are on the
market.
Mr. Westmoreland. OK. Do you know how many labels McNeil
manufactures for?
Dr. Sharfstein. Yes, we do know that, and we know that all
the products of concern have been recalled.
Mr. Westmoreland. There has been some question, I guess,
about the availability of these products for this, and that is
one of the concerns that my wife had was, well, where are we
going to get it from; what is it? Is there sufficient amount of
product on the market right now to where people can feel
comfortable that they would have the medication for the young
children?
Dr. Sharfstein. Yes. The drug shortage team at FDA looked
at that around the time of this recall and felt like there
would be adequate alternatives for the medications that had
been recalled.
Mr. Westmoreland. And have you put out a list of what those
might be or is it anything but?
Dr. Sharfstein. I think that, you know, it is what is
available in the stores, because the other ones have been
pulled off. We do have a shortage team that is looking to see
and even though it looks like there is enough across the
country, if there a spot shortage in a particular location, our
team can help direct the supplies and work with the companies
to direct the supplies to alleviate a spot shortage. That is
something that we were concerned about given the fact that the
facility is such a large supplier to the market.
Mr. Westmoreland. OK.
With that, Mr. Chairman, I----
Mr. Issa. Would the gentleman yield?
Mr. Westmoreland. I will. I yield.
Mr. Issa. I thank the gentleman.
Doctor, Mr. Connolly seemed to imply that the previous 8
years before you came to this job, that the FDA wasn't doing
their job. Do you know of any of that?
Dr. Sharfstein. Well, I think that, as I testified before,
we have not identified a case of a serious adverse event linked
to these quality problems.
Mr. Issa. No, that wasn't my question. Mr. Connolly implied
that the Bush administration didn't care about safety, that
somehow those 8 years were not good. You are heading as a
political appointee, but you are heading an organization that,
if I understand correctly, is almost all non-political
appointees, isn't that correct?
Dr. Sharfstein. That is correct.
Mr. Issa. So how would you rate the agency, the FDA, at the
time you came from a standpoint of professionalism and
consistency of inspecting with the intent of food safety, food
and drug safety?
Dr. Sharfstein. Well, personally, I have been incredibly
impressed with the people at the FDA. There are thousands of
professionals with backgrounds in medicine, law, there are
inspectors, there are chemists; and the work they do is because
they really care about the mission of the agency. I do think
that one of the messages that Dr. Hamburg has sent as the
Commissioner in the major speeches that she is going to place
an emphasis on enforcement and compliance that she believes is
very important, and she has really made the pitch to industry
that it supports industry when that happens, and that has been
something that she has focused on.
Mr. Issa. Sure. And that probably is very similar to what
her predecessor said when they came in. But I just want
everyone to understand for the record this is an organization
that the vast majority of it is controlled by career
professionals, scientists, physicians who do their job and
within the limits of the laws and the funding we give them, in
fact do the same job whether it is a Republican or a Democratic
administration. Isn't that true?
Dr. Sharfstein. You know, I am sitting here with two
terrific professionals from the agency who have worked across
multiple administrations----
Mr. Issa. Well, then why don't we go to those two and just
answer. Do you see this as a dramatic change in the last 2
years, or is this essentially the same organization it was 2
years ago?
Chairman Towns. The gentleman's time has expired. I will
yield him an additional minute.
Mr. Issa. Basically, because the statement was made, I just
would like the career professionals to answer if in fact this
is substantially the same organization with the same mission
and the same level of care.
Ms. Autor. I would say that FDA, as you said, has thousands
of very hardworking career professionals who did very hard work
and do regardless of the administration. I think that we
welcome this administration's focus on enforcement and
compliance and are glad to see that, and we will continue to do
everything we can to ensure the safety, quality, and integrity
of the drug supply.
Mr. Chappell. Thank you. I concur in that and also say, as
Dr. Sharfstein has said, when Dr. Hamburg arrived and
reinforced the fact that enforcement was one of our major
tools, obviously, that was an issue that we have always dealt
with and also were encouraged by that.
Mr. Issa. Thank you.
Thank you, Mr. Chairman.
Chairman Towns. The gentleman's time from Georgia has
expired.
I now yield to the gentlewoman from California,
Congresswoman Watson.
Ms. Watson. Thank you so much Mr. Chairman. I think this is
a very crucial and essential hearing that you are having today,
and we all are concerned about the 775 adverse effects that
have been reported through Dr. Sharfstein's office and the
deaths that have occurred because of some of the products that
can be purchased over the counter. And this is directed to you,
Doctor.
According to McNeil, no raw material that tested positive
for objectionable bacteria were ever used in the manufacture of
their products. However, according to the Form 483 filed after
the FDA's April inspection of the Fort Washington facility, the
raw material samples pulled from testing are not statistically
significant enough to be a representative sample of that total.
So here is the question: What does McNeil need to do to
improve their sampling methods and what kinds of bacteria were
discovered in the raw materials, and what are the health
implications for children and for infants who might have
consumed the contaminated products?
Dr. Sharfstein. Sure. I am happy to address that. What
McNeil needed to do, and what they eventually did, is have a
process where if the bacteria was found in any part of a lot of
this substance, that they not use the whole lot. What they
started to do is they would use part of the lot that tested OK,
but the sampling wasn't good enough to assure that. So they
have now a new policy they don't take any of the lot, and that
is the right policy to have.
Ms. Watson. Did we pull those products off the shelves, or
did they pull them off the shelves?
Dr. Sharfstein. Yes, they did.
Ms. Watson. OK. And representatives from Johnson & Johnson
have stated that McNeil is committed to not restarting
operations until it has taken the necessary corrective actions
to ensure the safety and quality of their products. What do you
think are the most critical changes that McNeil needs to make
before the American people can trust the integrity of their
medicines again?
Dr. Sharfstein. That is an excellent question. I think
there is a broad answer to that question, which is that McNeil
needs to put in a very strong quality system that has some very
important basic components to it, where not only will things be
done correctly, but they have a strong way of catching if there
is a problem, investigating what that problem is, and
immediately solving that. And that approach is what FDA is
going to really insist on to be in place before the facility
starts manufacturing again.
Ms. Watson. I see. Now, do you have the authority to pull
these products off the shelves? I wasn't clear with the
testimony that preceded.
Dr. Sharfstein. FDA does not have the authority to require
recalls. Now, under certain circumstances we can go to court
and get seizures and injunctions and other things, but in terms
of a mandatory recall authority for drugs, FDA does not have
that authority.
Ms. Watson. The process of going to court is, in some
cases, time-consuming.
Dr. Sharfstein. Absolutely.
Ms. Watson. How can we help with FDA? I have another issue
and we had a hearing yesterday that deals with mercury
amalgams. I don't want to get into that; that took us 5 hours.
But I want to know what authority we can provide to you so that
we can take these questionable products off the shelves. Lives
are at stake here and you have testified to----
Dr. Sharfstein. Well, one of the things to note is that in
the food safety bill Congress is looking to give FDA mandatory
recall authority over foods; also authority to put in place,
require certain types of preventive standards to prevent
problems; access to records, easier access for FDA to records
at companies; and civil money penalties.
Ms. Watson. Let me just interject this question. You are
saying authority over foods. Can we add another line saying
anything that is ingested or digested through the mouth?
Dr. Sharfstein. I think that would be up to Congress.
Ms. Watson. That would go beyond just foods.
Dr. Sharfstein. Right. That would be up to Congress.
Ms. Watson. OK. As a doctor, would that clarify what you
need to understand we can do? I want to make it easier for you
to indicate.
Dr. Sharfstein. I appreciate the question tremendously.
Ms. Watson. And we make the policy, so----
Dr. Sharfstein. Right. No, absolutely. The administration
hasn't worked out a final position on this with respect to
drugs, but the administration does have a position with respect
to foods, and these are the types of things that the
administration is looking at with respect to foods, and there
is no question that it is relevant for drugs.
Ms. Watson. OK, I am going to have my staff write a letter
to you and we are going to suggest this language, and then you
can take it the rest of the way.
Dr. Sharfstein. Thank you very much.
Ms. Watson. Thank you very much. My time is up.
Chairman Towns. We will leave the record open for it.
I now yield 5 minutes to the gentleman from California, Mr.
Bilbray.
Mr. Bilbray. Thank you, Mr. Chairman.
Doctor, let me first thank you very much for a very
measured response, a very measured and thoughtful approach to
this issue. I think it is so quick for us to want to go from
one radical extreme to the other, and I appreciate the fact
that I think some people would say your experience here, I
think your experience in the real world, doing local health
gives you that measure of moderation and consistency, and I
think that really helps the entire process.
One of the things that I really want to focus on is that we
have talked about how do we respond to this and, as you said,
we sort of addressed the issue before it became chronic, before
it became a crisis. As we look at the way we can improve this,
I have some questions about your auditors when they go in. How
do you assign the inspectors to do these inspections for the
facilities?
Dr. Sharfstein. They come out of the district office. FDA
has a number of district offices around the country and they
have a staff of inspectors, so the firms are inspected by their
local district office professional inspectors.
Mr. Bilbray. OK. Does the same inspector go back and
inspect these facilities each time, or is there a rotation? Do
you know how they allocate personnel toward certain facilities?
Dr. Sharfstein. I am going to maybe ask Mike Chappell, who
oversees all the inspectors, to answer that question.
Mr. Chappell. Well, thank you. In response to your
question, we make sure that the individuals that conduct these
inspections have the proper level of training and experience.
Indeed, if they are at a firm where there are some significant
problems, they also are able to call upon expertise both within
the inspector group and also other places in the agency. We
don't have a policy that the same investigator can't go into
the same firm; oftentimes they do. But in many of the cases of
these large firms, there will actually be a team of inspectors
that will go in just due to the sheer size of the firm.
Mr. Bilbray. So, in other words, you have a policy that you
may have an inspector go in with a general oversight, but if he
finds specific concerns, he can then call in sort of a delta
team that specializes to help him focus on some of the concerns
and bring the level of expertise up a little bit on those
specific issues?
Mr. Chappell. Yes, exactly. That is exactly it. If there is
a specific manufacturing process or a specific issue that we
have other people with greater expertise or experience, they
are available to be called in for these inspections, yes.
Mr. Bilbray. Now, when we talk about the inspectors and
their relationships with the facility itself, what is the
policy and what is the practical application of communication
contact with the facility or individuals who operate the
facility by the inspectors other than during inspection, other
than during the official process of review and inspection of
the facilities, as we say, off-campus contacts? What is the
policy and what is the reality in what level of contacts off
campus or out of the inspection process do these inspectors
have with operators or owners of these facilities?
Dr. Sharfstein. I would say that there is quite a lot of
communication between the company and its district office, and
maybe, Mike, if you want to talk about some of the examples. If
they find problems in the facility, for example, it is not
during an inspection, there are certain types of problems, they
have to notify the district office about.
Mr. Chappell. Just to make sure I understand your question,
are you talking about an inspector or investigator that is not
conducting an inspection, that has no relationship with that
company as it relates to an inspection or investigation?
Mr. Bilbray. Yes. I am really looking at, Doctor, one side
to look through the official communications. But what I am
saying is what is the policy about unofficial contacts that may
not be directly related to the responsibility of the inspector
to the facility, but outside of official contact? What kind of
policy do you have specific to those contacts outside of
official----
Dr. Sharfstein. I see. I am sorry, I may have misunderstood
the question.
Mr. Bilbray. That is OK.
Dr. Sharfstein. You are asking about like after-hours
contacts, that sort of thing?
Mr. Bilbray. Right.
Dr. Sharfstein. I thought you meant outside of the
inspections, but not outside of the job.
Mr. Bilbray. I understand that.
Dr. Sharfstein. He means outside the job.
Mike, do you want to?
Mr. Chappell. Well, I can certainly say there is
professional integrity that we expect of our investigators, and
if they are involved in activities with company officials as it
relates to some type of relationship, such as a job seeking,
etc., we have standards for that prohibits that kind of
activity.
Mr. Bilbray. OK. I appreciate that.
You know, Doctor, I had the pleasure for a decade of
supervising an environmental health department doing this kind
of inspection and an Air Resources district doing this kind of
inspection, and there are two schools of thought, and I think
too often people take the punitive approach that my air
district was involved in for too long, rather than a
cooperative; and one thing I was very impressed with our
environmental health people was they saw their job was to help
the private sector stay within the law, stay within the safety
boundary, rather than what I ran into with a lot of my air guys
that were looking, the cop mentality of trying to catch people
crossing the line and being punitive rather than cooperative.
And I know people will attack you for trying to work with the
private sector at staying within the framework, but I think we
all remember busting people or finding fault is not the answer,
but to avoid the problem, and I appreciate your efforts.
Chairman Towns. The gentleman's time has expired.
Mr. Bilbray. Mr. Chairman, could I allow the doctor to
comment on that?
Dr. Sharfstein. Sure. I would say I absolutely agree with
that, and that was the approach we had in Baltimore. It is very
important to work cooperatively where you can, and we, in
Baltimore, actually had a Web site where we posted common
questions so that people could get information. We weren't
counting success by the number of closures, but we wanted to
have success by compliance; and that is the same thing at FDA.
Actually, one of our transparency recommendations parallels
that, that FDA should be more aggressive in telling the
regulated community about the kinds of problems that we find so
that people can correct them in advance, not whether we can
find them at every place.
Mr. Bilbray. Thank you very much, Mr. Chairman.
Chairman Towns. The gentleman's time has expired.
I now yield 5 minutes to the gentleman from Missouri, Mr.
Clay.
Mr. Clay. Thank you, Mr. Chairman. Let me thank you and the
ranking member for holding this hearing on a serious matter of
public health and public safety.
Maintaining the highest standard for manufacturing medicine
is essential to the safety of the American consumers. Let me
ask Dr. Sharfstein. I have two children, 9 and 16. Do you
advise me, as well as the rest of the people listening and
viewing this hearing, to stay away from these products, from
Johnson & Johnson, from Motrin, from Tylenol, and whatever else
you found to be problematic?
Dr. Sharfstein. We are advising that people throw out the
recalled products, yes.
Mr. Clay. What about just the brand itself?
Dr. Sharfstein. I don't think we would go that far, because
we are looking at each of the different issues at the different
facilities. But there is a pretty big list of products that we
are staying people to stay away from right now.
Mr. Clay. You know, looking at the observation from your
first report and then from your report in April 2010, it
appears that you observed many of the same deficiencies again.
Is this a correct assessment?
Dr. Sharfstein. I think that there were some similarities,
but we found some new ones in April 2010 that were extra
concerning.
Mr. Clay. In your opinion, how seriously did McNeil take
its response to your inspections?
Dr. Sharfstein. I think that what happened over this period
is FDA was intensifying its scrutiny and that really culminated
in this February meeting, which was an extraordinary meeting
with the senior leadership of the parent company, where FDA
really said there is a problem of compliance at your company;
and our sense is they took that very seriously and have made
some major changes to how they oversee quality across this
particular company. You know, we wish it hadn't come to that,
but I think it was necessary for FDA to really talk to the
company about the company's overall compliance problems.
Mr. Clay. Now, it is my understanding that reports of
suspicious odors were made as early as 2008. Is that correct?
Dr. Sharfstein. That is correct.
Mr. Clay. And how long did it take McNeil to begin a
comprehensive response to these complaints?
Dr. Sharfstein. At least a year, I think.
Mr. Clay. A year?
Dr. Sharfstein. That is correct.
Mr. Clay. OK. So they didn't take the report seriously.
They didn't take the complaint seriously.
Dr. Sharfstein. FDA's view is that they should have
reported that to the agency and that they didn't at that time,
and then, when they did report it to us, it required a lot of
oversight by FDA for them to realize the scope of the problem,
and eventually that led to a significant recall. And because of
their failures in that regard, FDA sent them a warning letter
on January 15th of this year that not only called attention to
the problems, but called attention to the failure of corporate
oversight.
Mr. Clay. So, in FDA's opinion, their response was not
timely, nor appropriate.
Dr. Sharfstein. That is correct.
Mr. Clay. Do you believe that Johnson & Johnson's
participation in recalling the contaminated product was
effective?
Dr. Sharfstein. I believe that they have gone about the
recall, particularly this most recent recall, very vigorously,
and they have made a lot of information available to the public
about it.
Mr. Clay. What new regulations do you believe should now be
enacted to protect American consumers from the contaminated
medicines we are investigating today? What else can we do?
Dr. Sharfstein. One of the things we have been talking
about are some of the authorities that are being looked at
under the food safety bill for food that relate to things like
mandatory recall authority, easier access to records to FDA,
civil money penalties. Those are things that have been
discussed.
Mr. Clay. Do you believe that contamination of this
magnitude has implications for possible terror threats?
Dr. Sharfstein. I don't know if I can answer that question
without thinking about it some more. In general, this is really
a product quality issue that we see and have seen for a while,
and FDA believes it is important, just in general, that
products be made according to the best specifications so that
they are safe and effective as possible, and it is really
product quality that is driving our strong work in this area.
Mr. Clay. And how often do you check quality with the
manufacturers?
Dr. Sharfstein. It depends on the company and it depends on
their record. And this is a company that got extra scrutiny
from FDA because of our concerns.
Mr. Clay. Thank you.
I yield back.
Chairman Towns. The gentleman's time has expired.
Before we move to the next questioner, let me yield 30
seconds to the gentleman from California.
Mr. Issa. I thank the gentleman. To clarify the record, I
would ask unanimous consent to be able to place in the record a
letter from the McNeil Consumer Healthcare Division in which
they say call 888-222-6036. I won't put this in the record, but
if you do that rather than throwing away medicine, you return
it and you are paid $15 on this check. So I would just ask that
be placed in the record and that it be clear that the recall
does cause this division to pay for healthcare products
returned to them.
Chairman Towns. Without objection, so ordered.
[The information referred to follows:]
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Chairman Towns. I now yield 5 minutes to the gentlewoman
from California, Congresswoman Speier.
Ms. Speier. Thank you, Mr. Chairman.
Along those same lines, let me ask FDA do you have this
telephone number on your Web site to alert the consuming public
that they can contact McNeil and get reimbursed?
Dr. Sharfstein. I believe we do. I believe that we link to
all of McNeil's materials.
Ms. Speier. Well, I am not talking about linking, but
actually having a notice on your Web site to call this number
and that you can then get a reimbursement.
Dr. Sharfstein. I would have to----
Ms. Speier. And if you don't, I think you should.
Second, I think it is very important for the consumers to
be told that they shouldn't throw away these prescription drugs
that then get into the water system; that they should properly
dispose of them in a manner that will not have it being leached
into the water system and then creating more problems down the
road.
So I want to talk about the elephant in the room. And I
think the elephant in the room is that you don't have recall
authority. This has been a voluntary recall by McNeil of 43 of
their products, correct? So if they had chosen not to recall
those products, you would have had to go to court in order to
effectuate that result. Is that correct?
Dr. Sharfstein. And it would have been challenging to do it
through court, actually.
Ms. Speier. So you probably wouldn't even have been able to
do it through the court.
Dr. Sharfstein. We would have had some ability to do some
of it through court, but I think in this case McNeil and
Johnson & Johnson agreed to do the recall. But I think that
part of the issue, if you look across this whole time period,
is that from the point of wanting to have a recall, there were
some delays, and I think that it is a fair question to ask
about mandatory recall authority.
Ms. Speier. So you don't have mandatory recall authority.
If they had chosen not to recall those products, those products
would still be on the shelves today. Is that a fair comment?
Dr. Sharfstein. I think that probably is a fair comment,
yes.
Ms. Speier. All right, so, Mr. Chairman, I think that is an
issue that really needs to be addressed.
Second, if you look at the behavior of McNeil over the
course of these 2 or 3 years, it reminds me of a kid in school
who continues to get Ds, no one basically takes an action, the
kid never goes to the principal's office until 3 years down the
road, and very little action occurs. So my question is really
about fines. Since your real power is somewhat limited, outside
of suggestions and negotiations, what kind of fines can be
imposed? Can you close them down for 10 days? What hammers do
you have to utilize in your regulatory function?
Dr. Sharfstein. I think I may ask Deb Autor to answer that
question. I can tell you we do not have civil money fines for
these kinds of violations, so there are criminal penalties that
would require going to court to get. But in terms of the
ability to assess civil money penalties, which is part of the
food safety bill, we don't have that in this area of drugs.
Ms. Speier. OK, maybe that is part of the problem, that
getting compliance is more difficult because there is no hammer
on any of these companies. There is no downside risk not to
ignore what FDA is requiring because you don't have any
financial impact.
Dr. Sharfstein. Well, I think the story here is that we got
their attention and there were major changes that were made
over the course of this process even under the existing law.
Ms. Speier. I agree.
Dr. Sharfstein. But having said that, I think you are
asking a very fair question, which is, with other tools, could
FDA have gotten their attention faster and sooner and had a
quicker result. I think those are fair questions to ask. They
are being asked in the context of food safety as well.
Ms. Speier. And especially since you don't have the power
for mandatory recall. How else do you get anyone's attention?
So if Ms. Autor.
Ms. Autor. Yes, thank you. Just to add on to what Dr.
Sharfstein said, we do not have any civil money penalty
authority for violations of good manufacturing practices or
drug labeling requirements. And to clarify my answer to Ms.
Norton earlier, the only context in which we have civil money
penalties for drugs are related to certain application
requirements.
Ms. Speier. All right.
Ms. Autor. So it would be useful to us to have that
authority.
Ms. Speier. OK, my time is running out.
Cost recovery. A lot of money has been spent investigating
inspecting over and over and over again. How much has that cost
the taxpayers of this country and are you able to recover the
costs associated with that?
Dr. Sharfstein. That is a good question We would have to
get back to you on how much money exactly has been spent on it.
I think, as we said, there are a number of things that FDA is
still considering in terms of enforcement in this situation,
and one of our potential options would be to seek to get money
back from the company if certain criteria were met, and that is
part of the assessment that is probably going on.
Ms. Speier. I thank the witnesses. My time has expired.
Chairman Towns. The gentlewoman's time has expired.
I now yield 5 minutes to the gentleman from Massachusetts,
Mr. Tierney.
Mr. Tierney. [Remarks made off mic.]
Chairman Towns. Right.
I now yield 5 minutes to the gentleman from Illinois, Mr.
Davis.
Mr. Davis. Thank you very much, Mr. Chairman. I thank you
for holding this hearing.
Dr. Sharfstein, let me ask you when troubles emerge, are
found, or concerns raised, are there any remedies that can
occur prior to recall?
Dr. Sharfstein. In terms of whether we can fix the
manufacturing process before the product gets recalled?
Mr. Davis. Yes. I mean, if you find that there is a problem
with a product or there are concerns about a product, or
allegations of concerns about a product, what happens at that
point?
Dr. Sharfstein. I think there is an assessment. In some
cases the product may not have left the facility, and you don't
have to do a recall at all; it is still there and it just never
gets sold. And then there is an assessment, if it has gotten
sold, of whether it is something that is significant enough to
require a recall. And we have a standard for that and I think
one of the things we are going to do is take a look at that.
But sometimes, you know, there is a problem and it can be
addressed. We look at it, we get more information, and we
realize that it doesn't pose any risk at all and there does not
need to be a recall, but there will be fixed going forward. So
it is kind of a case-by-case determination. But there are
sometimes when we don't do a recall.
Mr. Davis. In the event that there is just a continuation
of production activity that is out of compliance or does not
meet specifications or requirements, what can happen to a
company?
Dr. Sharfstein. If there is repeated violation, what we
have seen so far is we call in the company, we can talk to
them; we can send them warning letters; and then they can have
other enforcement actions, including court-ordered injunctions,
we can seize their products; and then eventually we can refer
to criminal investigation and people can be prosecuted
criminally.
Mr. Davis. Can you think of any instances where that has
happened?
Dr. Sharfstein. There have been examples where there has
been a quality problem so significant that it has led to that.
Recently with a company actually in Massachusetts, there was a
major agreement that we reached, that has yet to be blessed by
the court, that relates to quality problems and I think well
over $100 million is being paid by the company back to the
government because of quality problems at their facility.
I think in that case and in this case it is really
important to realize the critical role that FDA plays for drug
safety; and I think it is important to think of what would have
happened in this case had FDA investigators not been on the
job, that we could expect that a lot of these problems would
not have been caught, that changes at the company would not
have been made, and it eventually could get to a situation
where there was a very serious risk to the public.
Mr. Davis. Thank you very much.
I have no further questions, Mr. Chairman.
Chairman Towns. Thank you very much.
Let me just make a quick statement to the Members. We will
have votes in just a matter of a few minutes, and what I would
like to do is to adjourn and come back 10 minutes after the
last vote. I can't say exactly what time it will be because I
am not sure as to how long it will take us for the four votes,
but we would take a recess and then come back and then do the
second panel.
If you would like to, fine.
Mr. Issa. Thank you, Mr. Chairman.
Just a very, very quick followup. The gentlelady from
California, before she leaves, under the previous
administration there was an egregious failure by the FDA, and
you probably remember it either from your time on the Hill or
when you in Baltimore. We had a spinach problem under the FDA.
A bag of spinach coming from a specific location and a specific
farm was tainted. That led to a total recall of all spinach.
You may not have had authority for mandatory, but the FDA made
sure that spinach was dead in America for a period of time.
What are you doing today to ensure, under the food side of
food and drug, that if in fact a field of some fresh vegetable
is tainted, that only that field, if it can be identified. In
this case the bags were numbered; they could have named the
manufacturer, or at least the bagger, and they didn't. What are
you doing to change that so the next time a bit of food,
similar to when beef is tainted and agriculture controls it,
that only the actual tainted or likely tainted or possibly
tainted is recalled, rather than an entire fresh vegetable
segment being off the market for a period of time?
Dr. Sharfstein. That is a good question and that is
something that we have thought a lot about. In fact, the
transparency report that we just posted has a whole section on
the importance of FDA being as transparent as possible about
the products that are not affected by recalls. For example,
when there was a pistachio recall, FDA linked to an industry
Web site of all the brands that were not involved with the
particular farm at issue.
Recently, there was a terrible outbreak that was related to
Romaine lettuce. FDA worked very quickly with States and
localities and the CDC, and we identified a distributor, and we
quickly were able to narrow it down so that, when we did do a
recall, it was a relatively narrow recall.
There is a balance between the scale of the recall and the
timeliness, because you need to move fast because it is often
perishable foods that you don't want people to eat. I think we
realize that we want to be as absolutely as narrow as we
possibly can when we are warning the public about food, and I
think that you can look at the Romaine lettuce situation that
just happened, that I was quite involved in, as an example of
an area where we did our best to narrow it as quickly as
possible and, in fact, it was very relatively narrow in how we
did it, and we were able to get the products of concern off the
market very quickly.
Mr. Issa. Last question. Do you need any new authority in
relation to food, such as, in the case of ground beef, every
package of ground beef that is ground outside of the store in
which it is sold has a manufacturer's ID, date code, and so on,
so that the consumer can make a decision about whether they are
covered by a code. In the case of packaged vegetables, that is
also true. But in the case of unpackaged vegetables, the master
pack may or may not contain sufficient information to find out
for sure where it came from. Is that something that you could
do within your own rulemaking authority, or does Congress need
to act?
Dr. Sharfstein. It sounds like a question I am going to
want to get back to you on with a good answer, but----
Mr. Issa. I think the chairman would appreciate that for
the record.
Dr. Sharfstein. But I would say that FDA strongly supports
food safety legislation, and we think it is really critical for
our ability to establish the standards that are needed to
protect the food supply.
Mr. Issa. Thank you.
Thank you, Mr. Chairman. I yield back.
Chairman Towns. Right. Just before we recess, let me just
ask have you checked to see whether or not the quality control
staff has been decreased?
Dr. Sharfstein. At McNeil?
Chairman Towns. Yes.
Dr. Sharfstein. I believe that one of the things that we
are talking to the company about is their quality control
staff; what their qualifications are, what kind of plans they
are going to put into place. Everything related to the quality
control staff FDA is working with the company to make sure it
is satisfactory.
Chairman Towns. Just before we recess, the gentleman from
Maryland, any comments or suggestions?
Mr. Cummings. No, Mr. Chairman. Thank you very much.
Chairman Towns. Thank you very much.
We will now recess until 10 minutes after the last vote.
Cannot tell you the exact time we will come back because we do
not know how fast the votes will move, but this panel is
dismissed.
Dr. Sharfstein. Thank you.
[Recess.]
Chairman Towns. The committee will reconvene.
Our second witness today is Colleen Goggins, worldwide
chairman of the Johnson & Johnson Consumer Group.
It is committee policy that all witnesses are sworn in.
Please stand, Ms. Goggins, and raise your right hand.
[Witness sworn.]
Chairman Towns. You may be seated.
Let the record reflect that the witness answered in the
affirmative.
Ms. Goggins, please give your opening statement.
STATEMENT OF COLLEEN GOGGINS, WORLDWIDE CHAIRMAN, CONSUMER
GROUP, JOHNSON & JOHNSON
Ms. Goggins. Thank you, Chairman. Chairman Towns,
Congressman Issa, and members of the committee. My name is
Colleen Goggins, and I serve as the worldwide chairman of the
Consumer Group of Johnson & Johnson. In this position, I
oversee the products that include the pediatric Tylenol,
Motrin, Zyrtec, and Benadryl products that were recalled by
McNeil Consumer Healthcare on April 30, 2010. McNeil is a
Johnson & Johnson operating company, and I am pleased to
testify on behalf of Johnson & Johnson to present our
understanding of the events.
All of the Johnson & Johnson family of companies realize
that we have a responsibility to provide consumers with the
highest quality products possible. We are proud that our
products help millions of people around the world improve their
health and well-being. In this instance, we have not lived up
to that responsibility. The quality issues in this recall are
therefore a disappointment to our chairman, Bill Weldon, to me
personally, and to the thousands of employees in the Johnson &
Johnson family of companies.
The quality and process issues that we found at McNeil,
those that led to the recall and others, are unacceptable. On
behalf of McNeil and Johnson & Johnson, I apologize to the
mothers, the fathers, and the caregivers for the concern and
inconvenience caused by the recall. Johnson & Johnson embraces
the work of this committee and we hope that today's hearing
will be an important step in furthering public understanding of
the recall.
Unfortunately, there has been some confusion in the media
with respect to this recall. I would like to stress, therefore,
four key points that Dr. Sharfstein also reiterated this
morning. First, as the FDA noted last month, the health risk to
consumers from the recalled products are remote. Second, McNeil
has no indication of a serious adverse medical event caused by
any of the issues referenced in the recall announcement. Third,
no raw materials that tested positive for objectionable
bacteria were ever used in the manufacture of McNeil's
pediatric products. And, finally, McNeil rejected the products
that it found had excess active ingredient and these never
reached the marketplace.
Because the McNeil products are used by millions of sick
children each year, we receive many questions and reports on
possible adverse events. We take all of these very seriously,
assess all of them, and specifically investigate all serious
adverse event reports, whether or not the events may have been
caused by our products. As Dr. Sharfstein indicated, the mere
existence of these normal and expected reports does not alter
the medical conclusions of the FDA and our doctors that the
safety risk from the recalled products is remote.
The recall last month was implemented because of the
presence of minute metal particles detected in a small
percentage of products. To be clear, these quality issues,
including the minute particles, are unacceptable to us. For
that reason, McNeil implemented a broad precautionary recall of
liquid children's and infants' medicines on April 30, 2010.
Let me address the remote medical risks.
First, with respect to the minute particles, McNeil's
health assessment concluded that even if those products were
distributed and the particles were ingested, the particles were
inert, so small, and so few that they did not present a safety
or health risk.
Second, with respect to products with an excess
concentration of acetaminophen, which McNeil rejected, McNeil's
medical experts confirmed that even ingestion of the maximum
labeled dose over an extended period of time, with the highest
identified level of excess acetaminophen, would not present a
medical concern.
Third, with respect to raw materials, McNeil tested all raw
materials and rejected any containers of raw materials that
tested positive for objectionable bacteria. No raw materials
that tested positive were ever used in production.
Although the medical risks were remote, we recognize that
the quality and process deficiencies identified in McNeil's
Fort Washington plant must be remedied. My written testimony
contains additional details on these points and a summary of
the steps that McNeil undertook and is undertaking to act
quickly to implement this broad recall and the steps that
Johnson & Johnson and McNeil are taking to address quality
processes.
In particular, we have made a number of personnel changes
and embarked on a comprehensive assessment of McNeil's OTC
facilities both before the FDA inspection in April. The Johnson
& Johnson parent company is committed to providing McNeil with
all the resources and personnel needed to improve quality and
to ensure that its product and processes meet the highest
standards.
Johnson & Johnson and McNeil take these issues very
seriously, and we are committed to taking the steps necessary
to bring McNeil's operations back to the level of quality that
Johnson & Johnson demands of its companies and that the public
rightly expects of us.
Mr. Chairman, I would like to close in the same manner that
our chairman, Bill Weldon, concluded his letter to the people
who use our products: We will work hard to earn back your
confidence. I would now be happy to answer your questions.
[The prepared statement of Ms. Goggins follows:]
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Chairman Towns. Thank you very much for your statement, Ms.
Goggins. Before I begin, I want to say that Johnson & Johnson
is a family brand, and the American people have come to rely on
that for more than 100 years. Until recently, most people would
not think twice about giving their child one of your products.
In fact, most Americans have at least one or more of your
products in their home. But I have become deeply concerned
about your company. Information I have seen during the course
of your investigation raises questions about the integrity of
the company; it paints a picture of a company that is
deceptive, dishonest, and has risked the health of many of our
children.
As the ranking member, Mr. Issa, said earlier in his
opening statement, I hope that you will be forthcoming today
about your company. And on that note, let me just go to a
couple questions.
Is it true that excess amount of certain active ingredients
were found in your children's medicines?
Ms. Goggins. Chairman Towns, it is true that lots of the
product were produced with excess amounts of the medicines, but
these never reached the marketplace. In fact, as I think Ms.
Autor said earlier this morning, we produced something like 10
or 11 lots of product; 3 were rejected on that grounds, the
other 7 were tested.
And I should say we test all of our finished products
extensively; we take samples from the beginning, the middle,
and the end of manufacturing, and we make sure they are within
specification. They were. We released them to the marketplace.
When the FDA raised its concerns, we tested the last batch
which we had in our possession. We actually tested 1,200
bottles, and not one of the 1,200 bottles was over the
specified amount of active ingredient.
Chairman Towns. So was that a yes or no?
Ms. Goggins. I am sorry. That is that no product with
excess acetaminophen entered the marketplace, to the best of
our knowledge in testing.
Chairman Towns. But it was actually found in the medicine,
so that would be a yes.
Ms. Goggins. It was found, but it was rejected, sir. It
never reached the marketplace.
Chairman Towns. Would you agree that these quality control
issues are totally unacceptable?
Ms. Goggins. I would absolutely agree with that, yes, sir.
Chairman Towns. Did you have contractors go back to stores
and buy medicine, instead of recalling the medicine?
Ms. Goggins. Let me explain that, sir. I think it is very
important. There has been a lot of misinformation about the
entirety of this recall, and I am glad you raise that issue
right now, because I think there are misperceptions.
We did have a Motrin dissolution issue in 2009. It was for
a small product that was distributed in gasoline stations. We
discussed with the San Juan district of the FDA this issue. We
talked to them about hiring a third-party contractor to go to
see the breadth of the distribution of these products. So we
were in discussions with them. They knew that we had hired this
third party, and the third party did go out to make an
inventory, and we discussed that with the San Juan office of
the FDA. So there was never any intent to mislead or hide
anything from anyone.
Chairman Towns. So the San Juan office of the FDA were
aware of the fact that you were going out to purchase----
Ms. Goggins. That is correct, sir. We were in discussions
with them.
Chairman Towns. Let me make sure that I understand. Now,
you went out and you purchased them, but the FDA was aware of
the fact that you were going to do it?
Ms. Goggins. Let me see if I can explain what happened.
Chairman Towns. Yes, help me.
Ms. Goggins. We had a Motrin product where the dissolution
profile, or how it is solubilized, wasn't in specification. It
is a small product; it sold primarily in gas stations. We
discussed this issue with the San Juan office of the FDA and we
agreed or we offered to have a contract force go out and
identify how much of this was in the marketplace. The FDA was
aware that we were doing that in San Juan and we did that. I
can't tell you about the behavior of these contractors in the
market or what they said or didn't say or how they acted, but
clearly FDA was aware of this and there was no intent,
obviously, to mislead or hide anything.
Chairman Towns. In other words, for the contractors to go
in and say do not mention the fact that this is a recall? You
know nothing about any of that?
Ms. Goggins. I know nothing about that, sir. I know only
that we were in discussions with the FDA in San Juan over the
product issue and how we were planning to handle it with a
third-party contractor.
Chairman Towns. Do you have any kind of documents or
anything that might be able to confirm what you are saying?
Because the FDA is saying that they learned of this later on.
If you were in discussions with them, why wouldn't they know it
immediately?
Ms. Goggins. Chairman Towns, I can't answer that question.
What I can do is I promise you to get back to you with the kind
of documentation what we have regarding this issue. In fact, I
would welcome the opportunity.
Chairman Towns. Well, I would like for you to do that for
me because----
Ms. Goggins. I would be happy to.
Chairman Towns [continuing]. I just find this very, very
disturbing, the fact that they went in to purchase the
products. FDA is saying they had no knowledge of it and, of
course----
Ms. Goggins. No more disturbing than I do, sir.
Chairman Towns. Right. How can this happen in a company of
your size and reputation? I mean, how could something like this
happen? Your company has had a longstanding reputation.
Ms. Goggins. That is a question that we have been asking
ourselves, and what I can tell you is that we think it comes
down to a number of factors. It comes down to people and
leadership and processes. And what I can tell you is that we
have made significant changes in the leadership. We have
actually changed six key executive positions: we have changed
the head of OTC manufacturing; we have changed the head of OTC
quality; we have changed the plant at Fort Washington; we have
changed the head of quality at Fort Washington; we have changed
the head of quality at our Puerto Rico plant; we have changed
the head of manufacturing; and we have reassigned people at
other levels.
Chairman Towns. So all of your quality issues have now been
solved?
Ms. Goggins. Well, I would not say that, sir. What I would
say in addition is that we have undertaken a broad assessment
of all of our OTC plants; we have engaged a third-party expert
to take a look at our plants and help us do this assessment;
and we have committed to the FDA that by July 15th we will have
a master plan regarding the remediation of all of our plants as
necessary.
Chairman Towns. Thank you.
I now yield 5 minutes to the gentleman from California,
Congressman Issa.
Mr. Issa. Thank you, Mr. Chairman.
Since you patiently sat through the first hearing, you are
aware of my line of questioning, so I am going to sort of
followup, sort of FDA you.
Ms. Goggins. Sure.
Mr. Issa. You told me, in your testimony and in the
chairman's questions, you said basically there was no safety
issue in relation to the product that got out of the plant,
period. Not the product that may have been multiple times its
advertised dosage that remained in the plant as defective
material, but the product that got out of the plant, as of
right now, the science--both at the FDA and you--consider that
there was no health risk from that product. Is that correct?
Ms. Goggins. Yes. The FDA and Johnson & Johnson and McNeil
is aligned that the risk of a serious health event is remote
and, to date, there have been no serious health events
associated with any of the reasons for the recall.
Mr. Issa. OK. So the recall was more about failure to live
up to your own standards and, therefore, a recall; and, of
course, the potential that if you didn't live up to your own
standards, something bad could happen. But the actual product
being recalled is not dangerous to the consumer.
Ms. Goggins. That is correct.
Mr. Issa. Now, ma'am, you are very good and scientific. If
I understood what you said about the Advil product, the
gasoline station----
Ms. Goggins. Motrin.
Mr. Issa. Motrin. Wrong brand. The Motrin. What you have is
paper two-packs that they sell at gas stations, and if you take
these you are not getting much use out of them because they
don't dissolve properly. Is that right?
Ms. Goggins. That is correct, yes.
Mr. Issa. So, in plain English, they simply wouldn't cure
your headache, but they wouldn't hurt you.
Ms. Goggins. It would take longer to cure your headache,
yes, but they would not hurt you, no, sir.
Mr. Issa. OK, so it is not going to hurt you, just not
going to be----
Ms. Goggins. That is correct.
Mr. Issa [continuing]. As good as advertised. And you hired
a contractor to try to do it and you have said under oath you
did inform the FDA, at least at their local level.
Ms. Goggins. Yes.
Mr. Issa. I was a manufacturer for 20 years. Under ISO
9001, if you find a defect, you do two things: you segregate
the defects and, of course, you go through a quality analysis
to try to keep that from happening again.
Ms. Goggins. Right.
Mr. Issa. In the case of the Fort Washington facility, if
that was where these products were produced that were multiple
times their normal dosage--or was it Puerto Rico?
Ms. Goggins. That was Fort Washington, sir.
Mr. Issa. Fort Washington. You segregated the product, is
that correct?
Ms. Goggins. We did.
Mr. Issa. You destroyed the product.
Ms. Goggins. I believe so.
Mr. Issa. And what steps were taken to prevent this from
reoccurring, if you know?
Ms. Goggins. Yes. I honestly don't know the answer to that.
What I can tell you is that we had a rigorous testing program
to ensure that the products were within specification before
they hit the marketplace, and we did go back and we took a look
at the last lot that we had in our possession, did extensive
testing, 1,200 bottles. I can't answer right now that we did or
didn't go back to test the root cause.
Mr. Issa. Now, some months ago we think famously, but we
are in Washington, so our image of what is famous may not be,
but we had Akio Toyoda sitting where you are sitting. He made
commitments to us that he would use dramatic resources, on a
scale not seen before, to change his company to be the leader,
not the follower, ahead of, not behind in quality. Can you make
that same commitment today on behalf of Johnson & Johnson?
Ms. Goggins. Yes, I can, and I think I can give you some
points that indicate there we are on the road to doing that.
Mr. Issa. Please.
Ms. Goggins. As I mentioned, we have changed a number of
key personnel, both in quality and in our manufacturing
organization; we have contracted with an outside expert with
pharmaceutical experience to help take a look at our plants
independently and determine what needs to be done; we have
undertaken on our own an assessment of all of our plants across
our North American OTC network; we have made some changes
already and, I think most importantly, we have committed to the
FDA that we will have a comprehensive plan that we will share
with them by July 15th.
Mr. Issa. Excellent answer. I hope you live up to it. I
expect, after 100 years of your company's good reputation, that
you have a reason to.
Let me followup with sort of a final line. Again, I said I
was a manufacturer. I am not bragging or complaining, but
before I could sell to General Motors, Ford, Chrysler, and
others, I had to pass independent QS and ISO analysis, and they
came back in regularly. So in addition to my own quality folks,
in addition to the auto companies and other companies I
supplied to over the years, we had ongoing annual and quarterly
independent evaluation. Is there a similar situation or is
there a similar capability within your industry and do you
employ it?
Ms. Goggins. I think there are two ways that we can do
that, sir. One is that we can employ the corporate quality
resources at Johnson & Johnson, and, in fact, we have brought a
lot of those to bear in the current situation; and they take an
independent look at our processes at McNeil. And the second
thing is, as I have mentioned, we have engaged a third-party
expert in manufacturing of pharmaceuticals, manufacturing
processes and sites, and we have engaged them to help us take a
look at our plants comprehensively.
Mr. Issa. In closing, I would say that public confidence
would be increased, and I hope that you will consider a level
of transparency of these independent reviews and, if at all
possible, that independent review be ongoing for a period of
time. I, for one, applauded the FDA for being diligent in this
case. As you can imagine, I am much more concerned about the
fact that you test your products three times as to potency and
what is in it, while in fact the FDA does not test even once
products coming in by the container load from countries and
facilities they have no ability to test.
So, Mr. Chairman, I hope that as we followup in this
process, that latter will be included in our question of is our
food and drug safe under the current law if they are importer.
And I yield back.
Chairman Towns. I thank the gentleman for his questions.
I now yield 5 minutes to the gentleman from Ohio, Mr.
Kucinich.
Mr. Kucinich. I would ask the staff to put the first
exhibit up.
Ms. Goggins, you have testified that no raw materials that
tested positive for objectionable bacteria were ever used in
the manufacture of McNeil's pediatric products. Now, an FDA
document, which I have a copy of here, states McNeil's lab
determined the presence of B. cepacia, an Avosil raw material
to be objectionable, placing the target population at risk if
the contaminant was in the product. The product is for use in
infants and children; however, the firm knowingly proceeded to
partially release some of the remaining raw material, Avosil,
which was used to manufacture more product.
What is your response?
Ms. Goggins. My response is that is untrue. What I would
tell you is that----
Mr. Kucinich. What is untrue, your testimony or this
document from the FDA?
Ms. Goggins. My testimony is not incorrect, sir. Let me
clarify the issue for you. This is one of the issues that has
been in the media and is simply incorrect. It is true that we
tested one incoming lot of Avosil, which is an inactive
ingredient in our children's products. It tested positive for
an objectionable bacteria. We rejected it. We test each of our
incoming raw materials; we have tested them all extensively. We
have never used a product that tests positive for objectionable
bacteria in our manufacturing process.
Further, when our products are manufactured, we test them
after manufacturing for the presence of harmful bacteria. We
have also had preservative systems and other capabilities in
our formulas which would, if a bacteria was in our product,
preclude the growth of that bacteria.
We also, then, given the FDA's concerns on this issue, went
back, retested, retained products of these products in
question. None of them tested positive for this bacteria. We
then went back and we tested the preservative systems by
inoculating them with bacteria, and the preservative systems
killed all the bacteria.
So I feel very confident in saying that we did not
knowingly use the products of bacteria and we did not release
them into the marketplace.
Mr. Kucinich. Thank you.
Mr. Chairman, this memo also states at the end of an
inspection, an FDA 483 was issued for deficiencies, including
failure to reject Avosil raw material after learning of B.
cepacia contamination of raw material, Avosil, then it gives
the lot number.
I submit this for the record.
Chairman Towns. Without objection, so ordered.
[The information referred to follows:]
[GRAPHIC] [TIFF OMITTED] T3140.031
Mr. Kucinich. Staff, put up the second exhibit.
A 6-year-old boy took medication that was manufactured at
your plants in Fort Washington and Puerto Rico. He died this
year. He tested positive for B. cepacia. I have a report here
which is a McNeil Consumer and Specialty Pharmaceuticals in-
house document dated May 10, 2010, where they state that the
child was taking medications that were manufactured at Las
Piedras plant and Fort Washington plant; that you apparently
were in touch with the coroner, who mentioned the child was
sick from nausea and vomiting, goes on to give other details;
say the child's sputum was tested positive for the B. cepacia
complex that is the subject of this.
Do you have any knowledge of that?
[The information referred to follows:]
[GRAPHIC] [TIFF OMITTED] T3140.032
Ms. Goggins. Yes, I do, sir.
Mr. Kucinich. And what is your response?
Ms. Goggins. My response is the same as Dr. Sharfstein's,
sir, in that we take every adverse medical event seriously. We
investigated this. We did discuss this with the coroner. The
products, as Dr. Sharfstein said this morning, tested negative
for the presence of B. cepacia and, in fact, the products that
the young child was administered were not in the investigation
of the B. cepacia issue.
Mr. Kucinich. Are you aware that the Food and Drug
Administration official also testified that a coroner's report
has not yet been returned on that?
Ms. Goggins. Yes.
Mr. Kucinich. No. 3, I would like the third exhibit put up.
Another 6-year-old boy with cystic fibrosis took Tylenol
and tested positive for B. cepacia. As I am sure you know,
children with cystic fibrosis are particularly susceptible to
B. cepacia, according to the CDC. And I also want to submit
this to the record without objection, an establishment
inspection report, McNeil Consumer Health Division, where it
confirms that a 6-year-old child tested positive for a form of
B. cepacia, and it says during the inspection another complaint
was received by the FDA; no details were given except there was
a death of a baby in reference to the use of concentrated
Tylenol infants' drops. This goes to the record.
[The information referred to follows:]
[GRAPHIC] [TIFF OMITTED] T3140.033
Mr. Kucinich. Ms. Goggins, can you tell the American people
what they should think when they learn that the FDA found that
McNeil knowingly let contaminated raw material into children's
medicine and that a contaminant was found in at least two
children, one of whom died?
Ms. Goggins. As I said, Congressman, we have never used
contaminated raw materials in the manufacturing of McNeil
pediatric products.
Mr. Kucinich. Mr. Chairman, that is at variance with the
document that we got from the FDA, and I think the committee
ought to take further note of that. Thank you.
Chairman Towns. Thank you very much. I would like to thank
the gentleman for his questions and, of course, we have not
made a decision as to what we are going to do from this point
on.
I now yield to the gentleman from Maryland, Mr. Cummings.
Mr. Cummings. Mr. Chairman, I would yield to the gentlelady
from Washington.
Chairman Towns. The gentlelady from Washington, DC, Ms.
Norton, is recognized for 5 minutes.
Ms. Norton. I thank the gentleman for yielding.
I am concerned, Ms. Goggins, about the delay here. I can
understand that there could be difficulties in manufacturing,
but I believe you need to clarify for the public why a delay
doesn't give the appearance of coverup. The FDA, as you know,
found, and I am using their words now, that your investigation,
or McNeil's investigation was unjustifiably delayed and
terminated prematurely.
Now, that is what concerns me, because, apparently, the
complaints began with an uncharacteristic bad odor. I can see,
given the symptoms that were reported, and we understand those
to be nausea and vomiting and diarrhea. When you are talking
about children, I can tell you, as somebody who had kids, they
all do that anyway. I can understand your thinking that could
have had any number of causes. What I don't understand is why
any manufacturer hearing, if you will forgive me, that its
product stunk wouldn't immediately see that as a justification
for investigation. Yet, I understand it took 100 complaints and
that you did not discover the contamination until September
2009, although this bad odor began in April 2008.
Why did it take you so long, particularly given the bad
odor, which seems to me should have been enough, to find what
the root cause of this contamination?
Ms. Goggins. Yes. You are referring to the recall that we
executed between November and January regarding the
contamination by products with TBA. We did receive a number of
complaints regarding these products. They were manufactured in
our Las Piedras, Puerto Rico facility. The complaints were
characterized by the consumers as a moldy and musty odor. We
did engage in an investigation of microbiology, because when we
get a complaint of musty/moldy, we assume that it is a micro
issue. There was no evidence of any kind of a micro issue.
For 6 months we then received no complaints whatsoever, and
we thought the issue had gone away. And then in April, I
believe, of 2009, the complaints came back, and that is when we
realized that we needed to deepen our investigation.
What I guess I would say about this is that this is a very
unusual compound; it is not well characterized, it is not well
known, it is has not been found in the industry----
Ms. Norton. Well, did it ever have a bad odor before? Is it
that unusual?
Ms. Goggins. Not due to this contaminant, ma'am, no. This
is a first.
So if I can just continue, please.
Ms. Norton. Yes.
Ms. Goggins. So we found that there was only one lab in the
country that we were able to locate that could identify what
this was, and there were only two experts in the world that we
would identify, one in California and one in France, to
characterize this. We finally found what the product was. When
we did, in January, we recalled quite an extensive amount of
product, about 565 lots of product; and I think we did it out
of an abundance of caution. I would add that there has been no
adverse medical events due to the trace levels of this
contaminant.
Ms. Norton. Yes, after the fact we are grateful. But, of
course, the FDA's concern was in the delay here. We don't know
what this might have done had it been something more serious,
particularly since the regulations require drug manufacturers
to submit field reports within 3 days of receipt of information
of bacteria contamination of some kind or, for that matter, of
any change or deterioration in a drug product. Apparently,
McNeil began receiving complaints in 2008, but you did not
follow this 3-day requirement and did not alert the FDA. Why
didn't you share this information immediately with the FDA?
Indeed, after you had results confirming contamination, you
didn't share those results immediately with the FDA.
Ms. Goggins. You know, I must say I am sorry, I am not
certain of the chronology of these events, but what I can tell
you is that----
Ms. Norton. You began receiving consumer complaints in
2008. And this is why FDA found unjustifiable delay and
termination prematurely: you began receiving them in 2008; the
regulations require you to report within 3 days of receipt of
any information regarding bacterial contamination. Did you
believe that you had to have that confirmed in some kind of way
before you alerted FDA?
Ms. Goggins. I can't tell you when we did or did not alert
FDA. What I can tell you is that we did undertake a micro
investigation of it, and it was found not to have any micro
contamination. Other than that, I can't tell you about the
chronology.
Ms. Norton. Again, I want you to know, Ms. Goggins, the
concern here from the point of the consumer----
Ms. Goggins. I understand.
Ms. Norton [continuing]. Is delay. Transparency helps a
great deal to ward off the notion of coverup. When FDA finds
unjustifiable delay and premature termination of complaints,
you say, yes, but we essentially waited to see if it would come
back; and when it came back we decided to do it again. That is
very troubling.
It seems to me, once you have 100 complaints about a bad
odor in something you are selling to the public, you ought to
want to tell the FDA immediately and you ought to want to do
something very quickly. It didn't happen very quickly if we are
going from April 2008 to September 2009.
Thank you, Mr. Chairman.
Chairman Towns. I thank the gentlewoman from Washington,
DC.
I now yield 5 minutes to the gentleman from Maryland, Mr.
Cummings.
Mr. Cummings. Thank you very much, Mr. Chairman.
Ms. Goggins, tell me, when did you learn that there were
serious problems at McNeil? When did you first learn that?
Ms. Goggins. I think we became aware, sir, that there were
quality issues probably in the first half of 2009.
Mr. Cummings. OK. And, according to our investigation, you
all had a major shakeup of McNeil management. I think you have
already testified to that, is that correct?
Ms. Goggins. We did replace a number of key quality and
manufacturing individuals, yes, sir.
Mr. Cummings. And can you tell me what went into that
decision? First of all, who made the decision?
Ms. Goggins. I was part of that decision, sir, and there
were other people who were involved as well. But I was part of
that decision.
Mr. Cummings. And why did you make that? What was that
decision? How did you come to the conclusion that you had to
shake up the management?
Ms. Goggins. I think the fact that we were not happy with
our quality processes based on some of the things that we saw
both in terms of recalls and in terms of some of the FDA
observations that we got in a Form 483. And I think we were
also concerned about some of the issues that have been raised
here today.
Mr. Cummings. When Dr. Sharfstein was testifying, I was
trying to get a clarification. You know, it is one thing if you
go to McDonald's and you get a sandwich and it has a worm in
it, God forbid, and then McDonald's says, you know, what? It is
no big deal; it can't do you any harm. That is one standard.
But the standard is there should never have been a worm in the
sandwich.
I know that is a little extreme for those people who
haven't eaten their lunch, but what I am saying to you is that
I am wondering if there is a different standard. First of all,
it sounds like McNeil didn't even adhere to its own standard,
let alone FDA's. Would you agree?
Ms. Goggins. I would say, sir, that we have a very high
standard, because I think consumers expect a lot of us, and I
think we did not adhere to that high standard on the quality
standpoint. That is why we enacted this broad recall.
Mr. Cummings. Can we put a pin in that right now? Where you
are right there. And should consumers expect the high standard?
Ms. Goggins. They should, sir, and our intention is to
remediate our plants to the highest possible standards.
Mr. Cummings. Now, Ms. Goggins, can Johnson & Johnson tell
the American people today with complete certainty that no
children who took these recalled medicines were harmed by them?
Ms. Goggins. What I can do is reiterate what Dr. Sharfstein
said this morning, that we believe that the risk of a serious
medical event is remote and there have been no serious medical
events associated with the reasons for the recall of these
products.
Mr. Cummings. Now, you said that you all had some concerns
and you heard Dr. Sharfstein's testimony; it sounds like he had
some concerns with regard to the way things were going along.
It is one thing if it is one incidence, but there is another
thing when there appears to be a pattern of these things. Is
that one of the things that concerns you?
Ms. Goggins. I think the number more than the pattern, sir.
There were a different number of plants and different number of
products and different number of medicines involved and
different number of issues. But the number concerned me, yes.
Mr. Cummings. And what were the top three issues that went
into your decision to bring in new management? Just curious.
Ms. Goggins. Well, as I said, I think that the----
Mr. Cummings. Give me the top three.
Ms. Goggins. Top three?
Mr. Cummings. So the public can hear what went on when you
all decided to make this change, so that hopefully they can
have some confidence when they buy these products.
Ms. Goggins. I think it was the number of quality issues we
had, the quality issues themselves, and the fact that the FDA
had made observations that we were disappointed in.
Mr. Cummings. Now, would you agree that government has a
role in making sure that products that end up in the medicine
cabinets of the public are safe?
Ms. Goggins. I would. Like most Americans, I have a great
deal of respect for the FDA. I think they have an important
mission, an important operation, and they have been very
professional in their dealings with us, so, yes, I agree with
you.
Mr. Cummings. Now, a little bit earlier there was a
statement by one of the witnesses from the FDA that this matter
had been referred for possible criminal prosecution. Did you
hear that?
Ms. Goggins. I did, yes.
Mr. Cummings. And are you concerned about that?
Ms. Goggins. Sir, my major concern right now is remediating
our plants to the highest possible level of quality and getting
products back on the marketplace for the consumers who need
them.
Mr. Cummings. And the Fort Washington plant, that is
basically closed down right now?
Ms. Goggins. It is closed down right now, yes.
Mr. Cummings. And when do you expect that to reopen?
Ms. Goggins. I don't know, sir. What I can tell you is that
we will not reopen that plant until we meet our own and the
public's and the FDA's standards for high quality and safety.
Mr. Cummings. Thank you very much.
Thank you, Mr. Chairman.
Chairman Towns. Thank you very much. I thank the gentleman
from Maryland.
I want to, Ms. Goggins, go back to this contractor
business. Now, the contractors, what were they contracted to do
and who contracted them? Explain all this to me, because it is
just not clear to me.
Ms. Goggins. I can tell you what I know, and then I promise
you I will come back to you with more information. The product
in question is sparsely distributed, as I understand it,
primarily in gas stations. So I think the idea was to go in and
identify how much product there was on the shelves. But beyond
that, I don't know, sir. We did contract them, but, as I said,
I am told that we contracted them in discussions and with the
knowledge of the San Juan office of the FDA.
Chairman Towns. So I guess what I am saying, were they
instructed to go out and buy if they found----
Ms. Goggins. I can't answer that, sir, nor can I answer the
question of what they are alleged to have said. I don't know
the answers to that.
Chairman Towns. Well, I would like for you to get back to
us on that, because these contractors, I just find this very
disturbing.
Ms. Goggins. As do I.
Chairman Towns. OK. So, in other words, you don't know who
actually contracted them or what their role and responsibility
was? You don't know any of that at this time?
Ms. Goggins. I know only that I imagine we contracted them,
sir, and we did so, as I am told, with the knowledge of the
FDA.
Chairman Towns. Were they instructed to do certain things?
Ms. Goggins. I can't tell you right now what they were
instructed to do or not, sir.
Chairman Towns. The quality control, do you have the same
amount of people in the quality control unit today as you had 4
years ago or 3 years ago or 8 years ago? What is the situation
with quality control?
Ms. Goggins. I believe that, at the Fort Washington plant,
our headcount is basically flat. I do know that between 2006
and 2009 we increased our spending 17 percent, and I know that
we have increased it again this year.
Chairman Towns. This document, that was actually just
brought to my attention, says this: You should simply act like
a regular customer while making these purchases. There must be
no mention of this being a recall of the product. If asked,
simply state that your employer is checking the distribution
chain of this product and needs to have some of it purchased
for the project. It is a demonstration project and we want to
purchase some for the demonstration project.
Is this accurate?
Ms. Goggins. As I said, sir, I have no idea. What I can
tell you is that I have no idea of whether or not that is true
or not, and I also have no idea of the context, sir. I have no
idea. All I know is that we did hire a third-party contractor,
and I do know that we did it with discussions with the FDA and
they were aware of it.
Chairman Towns. Well, let me put it this way. If this is
true, does it bother you?
Ms. Goggins. Again, I don't know the context, sir. I don't
know the context. I would have to understand the context. I
don't believe there was any intent to mislead or hide anything,
so I don't know the answer to that. So I can't answer that.
Chairman Towns. I am really trying to finish this, but, I
tell you, there are some unanswered questions here that are
very troubling.
On that note, I yield to the ranking member, Congressman
Issa.
Mr. Issa. Thank you, Mr. Chairman. First of all, I would
like to ask unanimous consent that all Members have 5
legislative days in which to ask additional questions,
supplement or provide information.
Chairman Towns. Without objection, so ordered.
Mr. Issa. Thank you.
This email I think speaks for itself. What we don't have
here is we don't have the individuals behind that. Can I ask
that you use your authority to investigate the email, we will
certainly give you a copy if you don't have it, and get back to
us in detail with either the individual and statements that
they would make for us subject to our interrogatories, if we
choose, and at least their side of the story? Because on the
face of it all, I look at this and it appears as though people
acting on your behalf, working for one of your subsidiaries,
did ask for this information, and we would appreciate knowing
for sure the individuals, assuming they are still working with
you. If they are not, then provide us the information and we
will contact them directly.
My understanding from our investigators is that there was a
cutback, not on your watch, but at this facility, in 2006, a
reshuffling of where quality personnel were located. Do you
know anything about that?
Ms. Goggins. No, I do not. What I can tell you is what I
referenced earlier, that in fact the headcount is flat from
2006 until now, and, in fact, spending was up 17 percent from
2006 to 2009 and is up again this year.
Mr. Issa. OK. I guess there were a lot of questions about
deaths of I hear a number as high as 37. To date, are you
involved in any litigation in which you are the defendant,
where someone is alleging that your products, those 37, if you
will, your Tylenol series products have led to the death or
severe injury of some child?
Ms. Goggins. Not to my knowledge. But let me just say that
I would not necessarily know that, and I would ask you if we
could get back to you after we talk to our legal group.
Mr. Issa. I would appreciate if you would respond in
writing.
I guess, last, you use imported products like all companies
at times, is that correct?
Ms. Goggins. I believe we do, yes.
Mr. Issa. My understanding is the source of the smelly
pallets could well have been imported wood. Is that correct? Or
at least not mainland United States.
Ms. Goggins. We believe that our supplier of packaging
components did use wood from Latin America that was treated
with this ingredient, yes.
Mr. Issa. OK, so I just want you to run us through. I have
dealt with import and production from all over the world and in
other parts of the world. What did you do after this extensive
research, finding only two people in the world that could do
it, but you got to the fact that you had a problem? What did
you do relative to the vendor for the future? In other words,
what corrective action was in your quality loop relative to not
having this happen again?
Ms. Goggins. One thing, the main thing we did, sir, was not
just for the McNeil organization, but for Johnson & Johnson in
total, we mandated that we would only use material that came in
on heat-treated wooden pallets, which precludes the use of this
fungicide, or plastic pallets, where you don't use it at all.
Mr. Issa. And I guess last, presently the Federal
Government has had a series of problems here in the United
States, more of them related to the vitamin industry of
imported vitamins from outside the United States, but some
related to non-prescription drugs. If you were sourcing
vitamins, ingestible products, non-prescription drugs from
completely outside of your own production, outside of the
United States and outside of factories you control, how often
would you test them and how often would you visit the
facilities, and what level of transparency would you require in
order to bring that product to the American people?
Ms. Goggins. You know, what I can do is perhaps draw an
analogy to what we do now with raw materials; and I imagine our
standards would be exactly the same. We require all of our
suppliers to give us a certificate saying that they have tested
the product and it meets the specification that is required
from them. That being said, when the products arrive at our own
facilities, we retest them for identity, for potency, for
microbial contamination. Then, when we use them in the final
goods, we do test them again.
Mr. Issa. I would appreciate that. Although we don't make
it a practice to look at any one private company when we write
legislation, this committee is very interested in the question
of drug and food safety, and as imports increase, both raw
materials that you may be checking, but finished product that
come in from overseas complete in the container, it became
apparent in the earlier FDA portion that it is not tested to
that level; that the inspection of your facilities seven times
in 5 years does not occur in an aspirin factory in China.
So I would appreciate the input you could give as we begin
looking at how we should instruct the FDA and other agencies to
inspect similar products coming in from around the world where
we have no such luxury as to send inspectors seen times in 5
years.
Ms. Goggins. We would be happy to provide that.
Mr. Issa. Thank you.
Thank you, Mr. Chairman. I yield back.
Chairman Towns. The gentleman from Maryland is recognized
for 5 minutes.
Mr. Cummings. Thank you very much, Mr. Chairman. I won't
even take 5 minutes.
I understand that you are basically retraining folks. Is
that retraining completed or is that ongoing?
Ms. Goggins. No, it is ongoing. We have already started to
undertake training programs.
Mr. Cummings. And what kind of things are you emphasizing
in this retraining?
Ms. Goggins. We are emphasizing a commitment to quality; we
are emphasizing adherence to good manufacturing practices and a
number of other things. I would say that our program definition
isn't complete yet, and one of the things we are doing with the
third-party experts we have hired, the independent experts, is
we are putting together a comprehensive plan which we will
share with the FDA on July 15th.
Mr. Cummings. Now, I am chairman of the committee on the
Coast Guard, and one of the things that they do in the Coast
Guard is whenever they have a problem, they take that problem
and they use it as a learning tool. Is that part of this
process?
Ms. Goggins. It could well be, sir. It is a good idea.
Mr. Cummings. Yes, it is helpful that way, because I
noticed that you ended your testimony saying that you all
wanted to make sure you earned the trust of the public. It
seems to me that if there is a training process, that in order
for it to be effective, not only effective with regard to
changes within the corporation, but also effective with regard
to the public having confidence, it seems as if you would have
to almost certainly show these new folks or the old folks,
whoever is there, whoever you are training, what has happened
and how those things should not happen again. So I would make
that very, very strong suggestion.
I just want to go back. I tell you, I am curious. I wish I
could have been a fly in the room when you fired all these
people. How many people did you all fire?
Ms. Goggins. You know, I can't give you the exact number of
people who are no longer in their positions.
Mr. Cummings. But you were there, weren't you?
Ms. Goggins. I was not there, no, sir.
Mr. Cummings. Oh, I thought you just told me you were in
the meeting.
Ms. Goggins. No, no. I was involved in the decision to fire
these people, I was not there myself.
Mr. Cummings. Oh. Oh. So you weren't in the room; you
helped to give the order.
Ms. Goggins. I was part of the discussion, yes, sir.
Mr. Cummings. OK. All right. I am sorry. But were a number
of people dismissed?
Ms. Goggins. Yes. We have a number of new people in the
most senior positions in both our quality and our manufacturing
organizations.
Mr. Cummings. And do you know whether a lot of these people
are from in-house or a lot of them outside?
Ms. Goggins. No, they were all our employees, sir.
Mr. Cummings. They were already employees?
Ms. Goggins. They were all our employees.
Mr. Cummings. Is that your normal procedure, when you have
a problem, you bring people from within, not anybody from
outside?
Ms. Goggins. No, we do both. We hire people both inside and
outside in different jobs, depending on the qualifications.
Then we also bring fresh pairs of eyes in, as we have done in
this case, with an independent third-party consultant.
Mr. Cummings. Just one last thing. I asked you about the
Fort Washington plant. What are you all doing now to try to
reopen it? In other words, what is the process there? First of
all, you plan to reopen it, do you not?
Ms. Goggins. We do plan to reopen it, yes, sir.
Mr. Cummings. OK. And what is the process there?
Ms. Goggins. The process right now, I guess there are two
major prongs to the process. One is we are undertaking a
massive assessment ourselves of not only the Fort Washington
plant, but all the other plants in our OTC network in North
America; and the second is we have brought in this third-party
expert who has a lot of pharmaceutical experience to help
independently tell us what we should do. Our plan is to combine
those two assessments and discuss the master plan for
remediation with the FDA by July 15th.
Mr. Cummings. And the last thing, when you all were meeting
and firing these people, making the decision to fire them, I
take it that this was embarrassing, this is an embarrassing
episode to you all, is it not?
Ms. Goggins. The entire episode is extremely embarrassing
to Johnson & Johnson. We take our commitment to our consumers
and quality and safety very seriously, and all of the people of
Johnson & Johnson and McNeil are deeply troubled by what has
been found and we are all deeply committed to remediating it.
Mr. Cummings. Well, I look forward to seeing the results of
your efforts to remediate.
With that, Mr. Chairman, I yield back.
Chairman Towns. Thank you very much. I thank the gentleman
from Maryland for his questions.
Ms. Goggins, and let me just say FDA, what we have heard
today is not too reassuring or comforting.
The initial story was bad enough: On April 30th, Johnson &
Johnson announced the largest recall of children's medicine in
history. But it turns out there wasn't just one recall. What we
have heard about today is rolling recalls, a phantom recall, a
plant shut down, and management firings.
I think there are still unanswered questions.
J&J told the committee staff that this most recent recall
involved only 6 million bottles. That is what they told staff.
That's a huge number. But today we learned from the FDA that it
was almost 20 times that, namely, 136 million bottles.
J&J testified that there was no attempt to hide anything.
But we uncovered a J&J document showing that they told their
contractor not to say this is a recall, just buy up everything.
J&J says that none of its contaminated products has had any
adverse health effects. But the FDA testified today that the
issue of whether any of these products caused deaths is still
being investigated.
This is an issue of trust. When parents and grandparents
give these medicines to their children, they want to be
confident that they are not harmful. Johnson & Johnson has the
duty to ensure their safety and the FDA has the duty to enforce
that duty.
One thing we know now is that the FDA needs mandatory
recall authority. They should not have to persuade a company to
recall suspect products. I intend to introduce legislation, Mr.
Ranking Member, to give FDA that authority, and I hope you will
join me. FDA should also have the power to order a halt in drug
production.
At this point, there are still many unanswered questions.
We intend to look further. We will hold the record open to get
additional information and to have some of the questions that
we raised answered and then, based on that, we will make a
decision as to what we will do from this point on.
On that point, I yield to the ranking member.
Mr. Issa. Thank you, Mr. Chairman. I won't have a closing
statement. I would just join with you in offering to work on
bipartisan legislation to provide FDA additional tools,
including mandatory recall capability.
I yield back.
Chairman Towns. I thank the gentleman for his statement and
his willingness to work along with me.
On that note, the committee now is adjourned.
[Whereupon, at 1:57 p.m., the committee was adjourned.]
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