[House Hearing, 111 Congress]
[From the U.S. Government Publishing Office]
DRUG SAFETY: AN UPDATE FROM THE FOOD AND DRUG ADMINISTRATION
=======================================================================
HEARING
BEFORE THE
SUBCOMMITTEE ON HEALTH
OF THE
COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED ELEVENTH CONGRESS
SECOND SESSION
__________
MARCH 10, 2010
__________
Serial No. 111-103
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Printed for the use of the Committee on Energy and Commerce
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COMMITTEE ON ENERGY AND COMMERCE
HENRY A. WAXMAN, California, Chairman
JOHN D. DINGELL, Michigan JOE BARTON, Texas
Chairman Emeritus Ranking Member
EDWARD J. MARKEY, Massachusetts RALPH M. HALL, Texas
RICK BOUCHER, Virginia FRED UPTON, Michigan
FRANK PALLONE, Jr., New Jersey CLIFF STEARNS, Florida
BART GORDON, Tennessee NATHAN DEAL, Georgia
BOBBY L. RUSH, Illinois ED WHITFIELD, Kentucky
ANNA G. ESHOO, California JOHN SHIMKUS, Illinois
BART STUPAK, Michigan JOHN B. SHADEGG, Arizona
ELIOT L. ENGEL, New York ROY BLUNT, Missouri
GENE GREEN, Texas STEVE BUYER, Indiana
DIANA DeGETTE, Colorado GEORGE RADANOVICH, California
Vice Chairman JOSEPH R. PITTS, Pennsylvania
LOIS CAPPS, California MARY BONO MACK, California
MICHAEL F. DOYLE, Pennsylvania GREG WALDEN, Oregon
JANE HARMAN, California LEE TERRY, Nebraska
TOM ALLEN, Maine MIKE ROGERS, Michigan
JANICE D. SCHAKOWSKY, Illinois SUE WILKINS MYRICK, North Carolina
CHARLES A. GONZALEZ, Texas JOHN SULLIVAN, Oklahoma
JAY INSLEE, Washington TIM MURPHY, Pennsylvania
TAMMY BALDWIN, Wisconsin MICHAEL C. BURGESS, Texas
MIKE ROSS, Arkansas MARSHA BLACKBURN, Tennessee
ANTHONY D. WEINER, New York PHIL GINGREY, Georgia
JIM MATHESON, Utah STEVE SCALISE, Louisiana
G.K. BUTTERFIELD, North Carolina
CHARLIE MELANCON, Louisiana
JOHN BARROW, Georgia
BARON P. HILL, Indiana
DORIS O. MATSUI, California
DONNA M. CHRISTENSEN, Virgin
Islands
KATHY CASTOR, Florida
JOHN P. SARBANES, Maryland
CHRISTOPHER S. MURPHY, Connecticut
ZACHARY T. SPACE, Ohio
JERRY McNERNEY, California
BETTY SUTTON, Ohio
BRUCE L. BRALEY, Iowa
PETER WELCH, Vermont
Subcommittee on Health
FRANK PALLONE, Jr., New Jersey, Chairman
JOHN D. DINGELL, Michigan NATHAN DEAL, Georgia,
BART GORDON, Tennessee Ranking Member
ANNA G. ESHOO, California RALPH M. HALL, Texas
ELIOT L. ENGEL, New York BARBARA CUBIN, Wyoming
GENE GREEN, Texas JOHN B. SHADEGG, Arizona
DIANA DeGETTE, Colorado STEVE BUYER, Indiana
LOIS CAPPS, California JOSEPH R. PITTS, Pennsylvania
JANICE D. SCHAKOWSKY, Illinois MARY BONO MACK, California
TAMMY BALDWIN, Wisconsin MIKE FERGUSON, New Jersey
MIKE ROSS, Arkansas MIKE ROGERS, Michigan
ANTHONY D. WEINER, New York SUE WILKINS MYRICK, North Carolina
JIM MATHESON, Utah JOHN SULLIVAN, Oklahoma
JANE HARMAN, California TIM MURPHY, Pennsylvania
CHARLES A. GONZALEZ, Texas MICHAEL C. BURGESS, Texas
JOHN BARROW, Georgia
DONNA M. CHRISTENSEN, Virgin
Islands
KATHY CASTOR, Florida
JOHN P. SARBANES, Maryland
CHRISTOPHER S. MURPHY, Connecticut
ZACHARY T. SPACE, Ohio
BETTY SUTTON, Ohio
BRUCE L. BRALEY, Iowa
C O N T E N T S
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Page
Hon. Frank Pallone, Jr., a Representative in Congress from the
State of New Jersey, opening statement......................... 2
Hon. John Shimkus, a Representative in Congress from the State of
Illinois, opening statement.................................... 3
Hon. Henry A. Waxman, a Representative in Congress from the State
of California, opening statement............................... 4
Prepared statement........................................... 6
Hon. Joe Barton, a Representative in Congress from the State of
Texas, opening statement....................................... 10
Prepared statement........................................... 12
Hon. John D. Dingell, a Representative in Congress from the State
of Michigan, opening statement................................. 18
Hon. Steve Buyer, a Representative in Congress from the State of
Indiana, opening statement..................................... 19
Hon. Phil Gingrey, a Representative in Congress from the State of
Georgia, opening statement..................................... 20
Hon. Bruce L. Braley, a Representative in Congress from the State
of Iowa, opening statement..................................... 21
Hon. Marsha Blackburn, a Representative in Congress from the
State of Tennessee, opening statement.......................... 22
Hon. Anna G. Eshoo, a Representative in Congress from the State
of California, opening statement............................... 23
Hon. Gene Green, a Representative in Congress from the State of
Texas, opening statement....................................... 24
Prepared statement........................................... 26
Hon. Tim Murphy, a Representative in Congress from the
Commonwealth of Pennsylvania, opening statement................ 28
Hon. Jim Matheson, a Representative in Congress from the State of
Utah, opening statement........................................ 29
Witnesses
Joshua M. Sharfstein, M.D., Principal Deputy Commissioner, Food
and Drug Administration........................................ 30
Prepared statement........................................... 33
Answers to submitted questions............................... 66
DRUG SAFETY: AN UPDATE FROM THE FOOD AND DRUG ADMINISTRATION
----------
WEDNESDAY, MARCH 10, 2010
House of Representatives,
Subcommittee on Health,
Committee on Energy and Commerce,
Washington, DC.
The Subcommittee met, pursuant to call, at 2:17 p.m., in
room 2123 of the Rayburn House Office Building, Hon. Frank
Pallone, Jr. (Chairman of the Subcommittee) presiding.
Members present: Representatives Pallone, Dingell, Eshoo,
Green, DeGette, Matheson, Barrow, Christensen, Sarbanes, Murphy
of Connecticut, Braley, Waxman (ex officio), Whitfield,
Shimkus, Buyer, Pitts, Myrick, Murphy of Pennsylvania, Burgess,
Blackburn, Gingrey and Barton (ex officio).
Staff present: Phil Barnett, Staff Director; Bruce Wolpe,
Senior Advisor; Ruth Katz, Chief Public Health Counsel; Sarah
Despres, Counsel; Rachel Sher, Counsel; Elana Stair, Policy
Advisor; Katie Campbell, Professional Staff Member; Stephen
Cha, Professional Staff Member; Virgil Miller, Professional
Staff Member; Allison Corr, Special Assistant; Eric Flamm, FDA
Detailee; Greg Dotson, Chief Counsel, Energy and Environment;
Dave Leviss, Chief Oversight Counsel; Karen Lightfoot,
Communications Director, Senior Policy Advisor; Lindsay Vidal,
Special Assistant; Mitchell Smiley, Special Assistant; Clay
Alspach, Minority Counsel, Health; and Ryan Long, Chief
Counsel, Health.
Mr. Pallone. The meeting of the subcommittee is called to
order, and today we are having a hearing on ``Drug Safety: An
Update from the FDA.''
I think before I give my opening statement, I am going to
recognize my colleague, the ranking member of the full
committee, the gentleman from Texas, Mr. Barton.
Mr. Barton. Thank you, Chairman Pallone. I just need to
make an announcement to the subcommittee. The ranking
Republican on the subcommittee is Congressman Nathan Deal of
Georgia. As we all know, he announced several weeks ago his
intention to resign effective last week. He has since withdrawn
the effective date of his resignation until after the vote or
votes on the House Floor concerning the comprehensive health
care bill. But during that time, Congressman Deal is not
planning on attending Congress or at least the subcommittee of
which he is the ranking member. Therefore, today I am
nominating Congressman Shimkus of Illinois to be the temporary
ranking member. That is unofficial obviously because there is
no such thing as temporary anything, but he will assume the
duties of Congressman Deal until such time as Mr. Deal does
effectively resign. When that happens, I will inform Mr. Waxman
that it is my intention to make Mr. Shimkus the ranking member
of the subcommittee subject to committee approval of such
designation. So for today's hearing and any subsequent hearings
that this subcommittee has, until Mr. Deal actually resigns,
Mr. Shimkus will assume the duties of the ranking member of
this subcommittee.
Mr. Pallone. Well, thank you, and let me congratulate Mr.
Shimkus. He has always been very helpful and tried to work in
many cases on a bipartisan basis, so I am very happy to welcome
him as the new or acting ranking member. I was going to ask,
though, the way you described that, Mr. Barton, it sounded like
Mr. Deal might still be here for a while, depending on the
circumstances.
Mr. Barton. It is up to you.
OPENING STATEMENT OF HON. FRANK PALLONE, JR., A REPRESENTATIVE
IN CONGRESS FROM THE STATE OF NEW JERSEY
Mr. Pallone. All right. We will have to see. I shouldn't
say that actually. He probably won't be here for very long
based on what I believe, but we will see. In any case,
congratulations.
Let me recognize myself for an opening statement. As I
mentioned, today the subcommittee is meeting to discuss drug
safety. It has been at least a year since our last hearing on
this issue and we are here to get an update and overview from
the FDA on current challenges and successes with respect to
drug safety. Recently there have been a number of drug-related
incidents that have shaken public confidence in the FDA's
ability to ensure that consumers are using safe and effective
drugs. In addition, reports from the Institute of Medicine and
the Government Accountability Office highlight the shortcomings
of our current system and provide guidance on how to strengthen
the drug safety laws to better protect the American public.
In response to the incidents, Congress passed the FDA
Amendment Acts of 2007, or FDAAA, I guess it is pronounced.
This bill was aimed to provide the FDA with additional
authorities, specifically post-approval authorities that would
help the agency keep drugs safe for consumers to use. For
example, the bill provided the FDA with the authority to
require drug manufacturers to conduct post-approval studies
that would monitor drugs for safety as they are used in the
broader population. The bill directed the FDA to establish a
post-market surveillance system to improve the agency's ability
to detect and act upon drug safety problems and gave the FDA
the authority to require drug label changes for safety reasons.
It also provided the FDA with the authority to impose Risk
Evaluation Mitigation Strategies, or REMS, for drugs and
biologics when necessary, and these REMS are designed to manage
known or potential serious risks with a drug or biologic to
ensure that the benefits of the product outweigh the risks it
poses to the patient.
Now, the FDA is here today to talk about how effective this
law is in protecting the American people from unsafe drugs, and
I am particularly curious to hear about the progress on the
implementation of some of the post-approval authorities and to
learn from the agency of potential stumbling blocks or
challenges that will require further Congressional action.
Outside of the FDAAA realm, however, we already know that
we need to do more to ensure the safety of our drugs. We all
remember that horrible incident in early 2008 that again
intensified this committee's focus on drug safety. Baxter
Health Care Corporation, one of the manufacturers of the blood
thinner heparin, which is used to prevent blood clots, began
noticing an increase in the number of adverse effects
associated with their product. After further investigation, it
was determined that the Baxter heparin contained a counterfeit
ingredient that mimics an ingredient normally used in heparin
production but that is highly toxic and dangerous to humans.
Baxter had received this ingredient from a manufacturer in
China, and upon further investigation by the FDA, it was
determined that due to a processing error at the agency, this
Chinese manufacturer had never been inspected by the agency.
Tragically, 81 individuals lost their lives as a result of the
contamination. Obviously this should not and cannot happen
again and we must do everything we can to ensure that it does
not happen again. And I am curious to hear the FDA's thoughts
and plans for improving import and supply chain safety,
especially since the GAO found that roughly 80 percent of the
active ingredients used in drugs are actually manufactured
abroad.
I and a few of my colleagues on the Energy and Commerce
Committee introduced a bill this Congress that aims to provide
the FDA with additional funding authorities to better regulate
the imported materials used in drugs. The bill would also place
more responsibility on the manufacturers to ensure that the
ingredients they are using are safe. As highlighted by the
heparin case, we know the devastation that can come from an
unsafe drug supply chain.
So I am looking forward to hearing from today's witnesses.
I now recognize our new ranking member, my friend, Mr.
Shimkus.
OPENING STATEMENT OF HON. JOHN SHIMKUS, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF ILLINOIS
Mr. Shimkus. Thank you, Chairman Pallone. Thank you for
your warm welcome. I want to thank Ranking Member Barton for
his trust and confidence in me, and I look forward to
continuing to work hard on behalf of the committee and really
the work we need to do here.
The FDA, with all the challenges and the inspection that we
do, it is still really the gold standard for health and safety
in the world. A lot of countries don't have to do all the
research and the testing because we in essence do it for them,
so although we will be inquisitive and we will be trying to ask
questions, I put that first on the table because they world
does rely on what we do here. And we have spent a great deal of
time on the issue of drug safety and the Food and Drug
Administration Amendments Act, and I look forward to Dr.
Sharfstein. Welcome, and I look forward to your updates. And I
want to continue to learn more about the Risk Evaluation
Mitigation Strategies, known as REMS, how that is progressing
and whether information is being disseminated in a user-
friendly manner. I am all about risk-based approach. The bills
that we passed in a bipartisan, I continuously spoke out on
risk-based programs. So I am very interested in that.
Your projections for advisory committee members in the
future and those projections, I believe it is important to
maintain credibility and expert participants. Recent stories
indicate the exception reductions provisions may be diluting
the advisory committee's ability to serve in those functions,
and we do want highly qualified and the best people to be
helpful.
But in general we know gaps remain when it comes to
ensuring the safety of drugs in the United States and I remain
committed to addressing those needs along with Chairman
Pallone. One thing I know about my colleagues on the other
side, they are tenacious in moving in that direction and we
want to be helpful in that manner. The FDA continues to make
progress in utilizing risk-based systems like PREDICT and I am
curious how this might translate in regard to targeting
facility inspections. Regardless of the end result, we know
that the FDA needs proper funding. We need to identify where we
can cut out wasteful spending and make sure funding to ensure
the safety of food and drugs in this country does not take a
backseat with our appropriators.
Lastly, echoing remarks I made in the past, I hope we can
work towards these goals using a prudent formula to get a good
bipartisan product. Chairman Waxman, Chairman Emeritus Dingell,
Chairman Pallone and Chairman Stupak working along with Ranking
Member Barton, Deal and myself came up with the food safety
bill that ultimately passed the House really in a huge
bipartisan manner, and I think we can do that if we move
forward in that direction.
I look forward to continuing our work to get legislation
signed into law and hope we can use the successes of food
safety as our motto in any drug safety-related legislation.
Thank you, Mr. Chairman. I yield back my time.
Mr. Pallone. Thank you, Mr. Shimkus.
Next is our full committee chair, Chairman Waxman.
OPENING STATEMENT OF HON. HENRY A. WAXMAN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF CALIFORNIA
Mr. Waxman. Thank you very much, Chairman Pallone, for
holding this hearing today and giving us the opportunity to
hear from the FDA on the critically important issue of drug
safety.
It has been some time since we focused on drug safety, but
we did indicate that we wanted to take up this bill after food
safety, which was the first step, and now we are going to turn
to drugs, medical devices and cosmetic safety issues.
We can't forget the lessons of the 2007 heparin
contamination catastrophe which resulted in numerous severe
allergic reactions and the deaths of at least 80 Americans. In
that case, the active ingredient was manufactured in China.
Thanks to the excellent work of the Subcommittee on Oversight
and Investigations in 2008, we know that this is not a unique
situation: the U.S. drug supply is increasingly sourced from
abroad.
In order to market a drug in the United States, FDA must
ensure that the drug meets our appropriately high safety
standards. So when ingredients or finished drug products are
manufactured abroad, FDA needs to expand its reach if the
agency is to meet its responsibilities.
As heparin illustrated, FDA clearly needs more authorities
and more resources to do a better job policing the safety of
imported products. But what heparin also demonstrated is that
we cannot expect FDA alone to do this job. We need to place a
greater onus on all manufacturers to oversee the safety of
their own products. This principle is reflected in the work
that Mr. Dingell, Mr. Pallone and Mr. Stupak did on their Food
and Drug Administration Globalization Act. For instance, the
bill would require drug manufacturers to implement Quality Risk
Management Plans to incorporate risk identification and control
into their production processes. We need that.
This is a principle that should be familiar to all of us.
The Food Safety Enhancement Act reflects this kind of approach
with respect to food manufacturers. So I am confident we can
get the same kind of bipartisan agreement to incorporate this
concept into a bill on drug safety as well.
I hope FDA will tell us today about what the agency
believes it needs to protect us from another heparin disaster.
I am also eager to hear about FDA's implementation of the
2007 FDA Amendments Act. Congress made some major strides
toward improving the safety of our drug supply in enacting this
legislation. For the first time, FDA was given the authority to
require manufacturers, among other things, to conduct post-
market studies, implement Risk Evaluation and Mitigation
Strategies, or REMS, and make safety-related drug labeling
changes. This hearing will be a great opportunity to learn
about FDA's challenges and successes with the use of these
authorities 3 years after the enactment of this landmark
legislation.
I want to thank Dr. Sharfstein for being here. He is no
stranger to me. We worked together in the past in the Oversight
and Government Reform Committee and on many of these very same
issues, and I am quite pleased that you are here and feel a
sense of confidence that you are responding to us on these
issues because I know you share our concern about them.
Thank you very much, Mr. Chairman.
[The prepared statement of Mr. Waxman follows:]
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Mr. Pallone. Thank you, Chairman Waxman.
Next is our ranking member, Mr. Barton.
OPENING STATEMENT OF HON. JOE BARTON, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF TEXAS
Mr. Barton. Thank you, Chairman Pallone. We appreciate this
hearing today. We appreciate our witness from the FDA coming.
Before I give my brief statement on the merits of the
issue, I do want to reiterate the importance I place on this
subcommittee and the importance I place on Mr. Shimkus assuming
the ranking membership. On the Republican side, we have a
bidding system for subcommittees where each member gets to rank
one, two, three their preference for subcommittees. The most
sought-after subcommittee on the Republican side of the full
committee is the Health Subcommittee, as it should be, given
the size of the health issue in our debates here in the
Congress. Congressman Deal has done an outstanding job, first
as subcommittee chairman and the last two terms as ranking
member but he is pursuing the governorship in Georgia, so I
thought long and hard about who to replace him with, and Mr.
Shimkus is somebody who has paid his dues. He has an almost 100
percent attendance record as a member of this subcommittee. He
also serves on two other subcommittees and his attendance
record there is excellent. He gets into the details of the
issues, and while any member of the subcommittee on the
Republican side I think would make an excellent ranking member,
I feel Mr. Shimkus will not have a learning curve, so I welcome
him to his new duties and I hope that he conveys to them the
same sense of excellence he has in all the other duties he has
assumed on the committee.
With regard to today's hearing, it is good to review what
we have done with the bill that we passed in the last Congress.
We are especially interested on the minority side, as has
already been outlined, the REMS issue, the Risk Evaluation
Mitigation, how that is working. We also would be interested in
hearing about the new rules that we put into statute regarding
conflict of interest and how those rules are being used. We
hear some concern that it has become difficult to get the
experts needed on these review panels because of the conflict-
of-interest rules that we have adopted, so we want to hear
about that.
As Chairman Waxman has pointed out, there is hope that we
can work in a bipartisan fashion on future FDA reform measures.
Chairman Dingell and I are working on that very issue at the
staff level, and we are hopeful that our friends on the
majority side will adopt the model of bipartisanship that they
exhibited in the last Congress and in this Congress so far with
the FDA and not the model of partisanship that they adopted on
the larger comprehensive health reform bill. I think the proof
is in the pudding. When we work together in a bipartisan
fashion, we certainly have differences but we end up with bills
that pass committee with almost unanimous support and bills
that pass the floor with over 400 votes. When the other route
is chosen, we have bills that barely pass committee and barely
pass the floor and as of now there doesn't appear to be a
compromise between the House and the Senate and the President
that can pass anywhere.
So we look forward to your testimony, and again, Chairman
Pallone and Chairman Waxman, thank you for this hearing.
[The prepared statement of Mr. Barton follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Pallone. Thank you, Mr. Barton.
Next is the chairman emeritus, and I should say that Mr.
Dingell, as many of you know, has had a long history of working
on this legislation or the issue of drug safety and food safety
and is the prime sponsor of the bill that we have been
operating on for the last couple of sessions on the topic.
Thank you, Mr. Chairman.
OPENING STATEMENT OF HON. JOHN D. DINGELL, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF MICHIGAN
Mr. Dingell. Thank you, Mr. Chairman, for those kind words
and I wish to commend you for having this hearing. It is a very
valuable event and it will provide us an opportunity not only
to receive and update information on drug safety activities at
the Food and Drug Administration but also to remind the
American people of the hazards which exist with regard to
unsafe food and drugs and the fact that this Congress needs to
move forward with legislation to address problems in both of
these areas.
As you know, Mr. Chairman, we have reported from this
committee a food safety bill which has passed the House. It
came unanimously out of this committee and it has passed the
House by an overwhelming vote. It sits, of course, safely
ensconced in the United States Senate as these things usually
do. We are hopeful that this hearing might trigger some
interest in the Senate in this matter so that they can commence
to go forward.
I want to commend my friend Mr. Barton for his comments
with regard to food safety and safety of pharmaceuticals. As
you know, Mr. Chairman, you, Mr. Stupak and I and Ms. Sutton
and Ms. DeGette sponsor H.R. 759, which is a very significant
improvement in all the things at Food and Drug including their
authorities to address drug problems, food problems and also
importation problems that deal with the importation at the
point of import and to see to it that inspections at home and
abroad and as well as that that good manufacturing practices
obtained abroad, and I want to observe that Mr. Barton worked
very well with us on that and that my Republican colleagues and
my Democratic colleagues and I will work well to get that bill
out of here and through the House.
I am hopeful that we can do something similar on the
remnants of the legislation which we have passed which was H.R.
759. We received technical comments from the Food and Drug
Administration and we believe that those are very helpful and
will be incorporated. As my colleague Mr. Barton has observed,
his staff and mine are working to see to it that we can bring
together a bill which can achieve the support of my colleagues
on the committee, and I look forward to the enthusiastic
support in this subcommittee and in the full committee, and of
course, I look forward to the help of Food and Drug and the
Department of HHS as well as the Administration.
According to a 2004 HHS report, the Nation's medicine
cabinets are still stuffed with enormous amounts of
pharmaceuticals. Almost half of all people in this country take
at least one prescription medicine and one in six has three or
more medications that they take. Americans have come to expect
that their prescription drugs will improve health and prolong
life expectancy. They do not expect their drugs to cause harm
or death. The Food and Drug Administration plays a critical
role in ensuring the Nation's drug supply meets the safety
expectations of American consumers. The role FDA plays is so
critical that it has earned that agency an American Food and
Pharmaceutical Products as the gold standard not only of
regulatory bodies but as regulatory substances.
Unfortunately, FDA approval of pharmaceuticals as a gold
standard is now called into question by an unfortunate series
of facts. Drug safety incidents have occurred and have created
a confidence crisis in FDA. During the past 8 years, Food and
Drug was led by leadership specialized at best in gross
incompetence or at worst severe deception, and as a result,
American lives have been placed in jeopardy under all the
products that are marketed under the regulation of that agency,
and of course, the confidence of the American people in that
agency has been severely compromised.
Now under a new Administration, Food and Drug has been
taking steps to rebuild, and through Congressional and
administrative action, the agency has gained additional
resources, not sufficient but to begin enabling it to move
towards doing its job properly though many including myself
still believe that the resources and authorities of Food and
Drug are still lacking in the wake of years of inattention and
starvation.
In 2007, the Congress made substantial progress in the way
of drug safety with the passage of FDA Amendments Act of 2007.
This law strengthened FDA's post-market safety oversight. No
longer is it ok for the oversight to end at the mere approval
of a drug. This is a significant step forward. However, it did
not take long before we were aware of enormous gaps in FDA's
ability to protect consumers from an increasingly global drug
supply. In 2008, in one instance alone, 81 deaths of Americans
were linked to recalled heparin that contained Chinese tainted
API. The safety of imported pharmaceuticals and supplies as
well as the raw materials from which these are made is a matter
of safety and great concern that must be addressed in this
Congress. Last year the Congress unanimously passed the
bipartisan bill I mentioned with regard to our food safety
supply. I believe that we can and should and will pass similar
legislation during this Congress.
I look forward to the deputy commissioner's testimony. I
hope he is able to give us better testimony than the
predecessor of the current head of FDA gave us when he came up
to tell us that all was well and to leave a patch of skin
behind in this committee because of the unfortunate character
of his testimony and his lack of information.
Mr. Chairman, I thank you again and I yield the balance of
my time.
Mr. Pallone. Thank you, Chairman Dingell.
The gentleman from Indiana, Mr. Buyer.
OPENING STATEMENT OF HON. STEVE BUYER, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF INDIANA
Mr. Buyer. Thank you very much.
For the past several years, I have been studying the
problem of counterfeit drugs entering our Nation through our 12
international mail facilities and express carrier facilities.
In 2008, Congress Matheson and I introduced the Safeguarding
America's Pharmaceuticals Act to combat the flow of unapproved
drugs into our country and to strengthen and safeguard the
domestic pharmaceutical supply by creating also this system of
electronic pedigree. At the beginning of last year when we
introduced the legislation, we then submitted to the FDA and
other stakeholders, Customers Border Protection and the
California Board of Pharmacy to improve the Safeguarding
America's Pharmaceuticals Act. I would ask you to look over
your left shoulder because there are two ladies that were a lot
of help. They put in a lot of time for the technical assistant.
Elisa Bernstein, thank you very much. We traveled to many of
these facilities with you. And Jeannie Ireland, thank you very
much for the technical assistance you have given to make this
legislation even better. Mr. Matheson and I have the commitment
of Mr. Dingell and we want to make sure that this legislation
becomes a reality.
Last June, Dr. Hamburg testified before this subcommittee
and stated that the problem of counterfeit drugs is a
significant concern and gave her commitment to working with me
to address the issue, so I turn ask for the very same
commitment.
The FDA then followed up in its response to many questions
for the record and confirmed that the agency supports a single
national uniform standard for a drug track and trade system.
Additionally, the agency addressed an issue of great importance
to me when it stated that it supports streamlining the
destruction of these unapproved FDA drugs that constantly come
into the market. And let us stop enabling these counterfeiters
by this policy of return to sender. It is just awful, and I
hope that you can address that to us. The worldwide counterfeit
drug market is expected to grow to $75 billion, so we have to
aggressively address this, and I look forward to working with
Mr. Dingell to do that.
So I know this is a great concern to you, and I look
forward to working with you and your comments. I yield back.
Mr. Pallone. Thank you, Mr. Buyer.
Next is the gentlewoman from the Virgin Islands, Mrs.
Christensen.
Mrs. Christensen. Thank you, Mr. Chairman. I am waiving my
opening statement.
Mr. Pallone. Thank you.
The gentleman from Georgia, Mr. Gingrey.
OPENING STATEMENT OF HON. PHIL GINGREY, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF GEORGIA
Mr. Gingrey. Mr. Chairman, before I start, let me join with
my ranking member on congratulating Mr. Shimkus as ranking
member of this Health Subcommittee.
Mr. Chairman, first I would like to thank you for calling
this hearing today. Ensuring that medications are both safe and
effective for our Nation's patients is a goal that I believe we
can all support. Whether our inquiries include pre-market and
post-market testing of products, domestic and foreign facility
inspections or even the authority and resources of the FDA,
this committee and its chairman should be commended for their
efforts today.
However, I want to focus for a moment on some troubling
news that just came out of Britain. As some of you may have
read earlier this week, the U.K.'s National Health Service
received four independent audits on the overall state of their
health care system. All four reports found a system that put
the politics of the government above the health of the patient.
One report based on the evidence of almost 200 top managers and
doctors in the British system found that hospitals ignored
basic hygiene so they could cram patients into beds to meet
waiting time targets, thereby losing sight of fundamental
hygiene requirements for infection prevention. This neglect of
the most basic hygienic standards was credited with causing the
deaths of 265 patients in 2005. All four reports in fact hit
the same note: the British system placed little emphasis on
patient care. Even more shocking, these reports are suppressed
by the British government and only came to light recently. To
quote the Times of London, ``These reports diagnose a blind
pursuit of political and managerial targets as the root cause
of a string of hospital scandals that have cost thousands of
lives.''
I see the same blind pursuit of political targets in our
current health care reform debate. For the past week, I have
seen the demonization of the insurance industry. Sure, the
industry needs reform. We all agree with that. But insurance
reforms alone should not be the reason for turning health care
over to our government lock, stock and barrel, and if the
Senate bill passes, what then? Who is going to monitor our
government when it controls all health care decisions? If the
British are our example, will politics supersede the needs of
patients here like they did in the U.K.? I fear that Washington
politics have already trumped their needs. Our constituents are
telling us that they want reform but not this reform. They
don't want a bill bought with political payoffs and backroom
deals. Every day they echo these sentiments, yet their elected
officials ignore them. They voted for a Republican to represent
Massachusetts in the United States Senate and still Washington
refuses to listen. If we cannot trust our government to put its
citizens first when debating a health care reform bill, how can
we expect it to safeguard their citizens' interests when it
controls health care? If Britain continues to be our example, I
fear for the safety of patients if our government controls our
health care choices.
Mr. Chairman, with that I yield back.
Mr. Pallone. Thank you.
Next is the gentleman from Iowa, Mr. Braley.
OPENING STATEMENT OF HON. BRUCE L. BRALEY, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF IOWA
Mr. Braley. Thank you, Mr. Chairman. I am very pleased that
we are holding this important hearing and I am very pleased
with the scope of the testimony that Dr. Sharfstein has laid
out in his written materials.
I want to begin my brief remarks by echoing the concern
raised by my colleague from Indiana, Mr. Buyer, because one of
the things that was very obvious to me when I visited the
Custom and Border Patrol inspection facilities in Nogales,
Arizona, and Mexico, is that we have an enormous problem with
counterfeit drugs entering through ports of access and other
places that are not being controlled, which contributes
enormously to the problem you have identified with the known
points of products for non-counterfeit drugs. So we have got
two major problems in terms of enforceability of the FDA's
mandate in counterfeit and non-counterfeit production
facilities overseas. We also have enormous challenges in terms
of the accountability of the manufacturers of those non-
counterfeit and counterfeit drugs in this country, and one of
the things that I hope you are able to address in your
testimony is what the FDA is doing to promote greater
accountability with those overseas manufacturers.
I also want to compliment you on some of the progress has
been made since the passage of the FDAAA because I personally
benefited from one of the changes you identified in your
statement where you describe the changes to the prescription
information of a class of antibiotics to warn about the risk of
tendon rupture. I have experienced a ruptured Achilles tendon,
and when I was prescribed those antibiotics, as a patient I was
given informed information to make a choice about whether or
not to take that antibiotic in light of my own health history.
So I can tell you that if consumers are presented with
information that allows them to make the choices that are best
for them based upon their own unique health conditions, the FDA
is fulfilling the mandate that you set forth so succinctly at
the beginning of your written remarks.
But I also want to hear from you in your testimony about
the Sentinel Initiative that you described, which you have
identified as a national integrated electronic system for
monitoring medical product safety. The concern I want you to
address is exactly what model that Sentinel Initiative is based
upon because I am familiar with other sentinel event reporting
systems that have been adapted in this country designed to
promote patient safety that have been woefully inadequate in
reaching the level of reporting that would be required to truly
bring about changes in patient safety.
So I look forward to your comments. I appreciate your
willingness to come here today. It is a very important subject
that affects every American, and this is not a partisan issue,
it is a bipartisan issue that every American should be
concerned about, and I yield back.
Mr. Pallone. Thank you, Mr. Braley.
The gentlewoman from Tennessee, Mrs. Blackburn.
OPENING STATEMENT OF HON. MARSHA BLACKBURN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF TENNESSEE
Mrs. Blackburn. Thank you, Mr. Chairman.
I am so pleased that we are doing an oversight hearing
today. Oversight is something that we should doing a little bit
more of, and I think that after we passed the FDA Amendments
Act in 2007 that was supposed to help streamline some of those
processes and procedures that it is important that we come back
and look at what is happening with the efficiencies in this
area as well as to look at the relationship between the FDA and
industry, and some of my colleagues have mentioned some of the
conflict-of-interest questions that we will have.
I also hope that today we are going to look at whether or
not the FDA has the appropriate resources as well as the
institutional will to continue to evolve and review processes
that are in place, and I know, Dr. Sharfstein, that you are
very well aware that with the inspections process with NDA and
ANDA, we hear from constituents who may have questions or
concerns as they have gone through that process. So I think
that is something we need to jointly look at to see is this
review process working and how do we simplify it, how do we
look at time, money, the usage as well as public safety. So I
thank you for your willingness to look at that.
The other point that I hope we look to is FDA's internal
problems and see if those have improved not only with the
decision-making process but also the oversight and the post-
market drug safety issues that are out there, the counterfeit,
and then let us also touch on one of the things we have talked
about repeatedly over the last few years which is your
interagency communications and the different divisions and how
they are transferring that information. Repeatedly we have seen
this as a roadblock or being cited as well we didn't know they
were doing. So I hope that you will take a moment to address
that.
I thank you for being here with us. We welcome you.
Mr. Chairman, I yield back.
Mr. Pallone. Thank you, Mrs. Blackburn.
And next, the gentlewoman from California, Ms. Eshoo.
OPENING STATEMENT OF HON. ANNA G. ESHOO, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF CALIFORNIA
Ms. Eshoo. Thank you, Mr. Chairman. This is an important
hearing, and I thank you for having it.
Before the FDA was created about a century ago, taking
drugs was a real gamble. There were elixir potions that were
sold door to door and ``medicines'' were really taken at one's
own risk. Today, as was stated previously and we all know,
there are millions of Americans that take drugs to prevent, to
treat and to cure ailments from the common cold to cancer, and
the science and technology progresses and I see every day the
new things that surface in my Congressional district and
certainly around the country, so do the complexity of drugs as
well as our ability to regulate them and ensure their safety.
So I think that the FDA is the gold standard in the world and I
think that we all want the FDA to remain the gold standard in
the world. The recent heparin incident was a stark example of
what happens when that standard is not followed and it cost 81
American lives. Lapses in drug safety not only harm patients
but they cause the public, and I think this is really an
important outcome of this, it causes the public to doubt the
government's ability to actually ensure safety. So we have to
maintain the trust and the support of the American people who
rely on safe and effective drugs.
I am very pleased to see Dr. Sharfstein here today. I would
like to know about how the FDA is implementing two provisions
that I offered in the Food and Drug Administration Amendments
Act to renew and improve the Best Pharmaceuticals for Children
Act, the BPCA, and the Pediatric Research Equity Act, PREA. The
provisions, as you know, were designed to improve drug safety
for children in two ways. First, under the BPCA, the
legislation provided an incentive for a drug of the innovator
company agrees to undertake comprehensive pediatric studies
requested by the FDA, and second, under PREA, the FDA was
granted the authority to require studies when there is a
demonstrated need and the drug companies are required to submit
a pediatric assessment. I am telling you what you already know.
So my thanks to Dr. Sharfstein for being here today. I look
forward to your testimony. I want to thank everyone that is
part of helping to keep FDA as the gold standard in the world
and to work with you and make sure that we provide the resource
that you need in order to do that and good public policy to
back it up.
Thank you, Mr. Chairman.
Mr. Pallone. Thank you.
Next is the gentleman from Pennsylvania, Mr. Pitts.
Mr. Pitts. I will waive.
Mr. Pallone. Thank you.
The gentleman from Georgia, Mr. Barrow.
Mr. Barrow. Thank you. I will waive.
Mr. Pallone. The gentleman from Kentucky, Mr. Whitfield.
Mr. Whitfield. Thank you, Chairman Pallone, and I also want
to congratulate Mr. Shimkus on his new responsibilities of this
subcommittee, and Dr. Sharfstein, we are delighted you are here
to bring us up to date on the implementation of this act of
2007.
People have already touched on a lot of these issues, the
safety of drugs coming into the country, the approval process,
whether or not there are adequate resources, and I just want to
point out one additional aspect of this, which is a little bit
different, but this committee a couple years ago passed the
National Prescription Drug Monitoring System which I think is
vitally important to health care providers. We continue to
struggle on getting sufficient funds to fully implement this
because of an unauthorized program started in the
Appropriations Committee but we have been working with both
sides of the aisle to try to address that issue and I certainly
look forward to your testimony on the other part of this
equation. Thank you.
Mr. Pallone. Thank you, Mr. Whitfield.
The gentleman from Connecticut, Mr. Murphy. Well, Mr. Green
just walked in. Do you want to go first? Mr. Green.
OPENING STATEMENT OF HON. GENE GREEN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF TEXAS
Mr. Green. I would like to put my full statement into the
record.
Following our chairman emeritus and the earlier statements,
first I want to thank you for holding the hearing and today
with new FDA folks on the current status of our drug safety
system, and a lot of our frustrated that the Senate hasn't
moved on the bill but I had the opportunity like a lot of
members on several hearings led by Chairman Pallone and
Chairman Stupak, the FDA and drug safety over the past 2 years.
All these hearings clearly show the FDA is woefully underfunded
and neglected by Congress for far too many years and that has
left the FDA without the resources, funding or technology it
needs to protect the American public from counterfeit or
tainted drugs entering our country. This committee worked over
a year on FDA drug safety legislation passed out of the
committee. The legislation is aimed at improving our drug
safety system by giving FDA increased resources for overseeing
facility inspections by the FDA, an up-to-date registry of all
foreign drug manufacturing facilities, country-of-origin
labeling, verification of drug purity and safety. It gives the
FDA the ability to issue fines and mandatory recalls, and also
the FDA's foreign drug inspection program needs to be changed
and some hurdles to overcome. The FDA currently does not have
the authority to conduct these inspections overseas and must be
invited to a plant to conduct inspections. That is almost like
me driving down the Houston freeway inviting an officer to
watch me while I speed. That just doesn't work in the real
world.
And Mr. Chairman, that is why I would hope with the new FDA
that they will not only take their job seriously, and I know
they do, but also we need to provide the resources for them,
and I appreciate the opportunity to give the opening statement
and again, I would like to have my full statement placed in the
record.
[The prepared statement of Mr. Green follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Pallone. Without objection, so ordered.
The gentleman from Texas, Mr. Burgess.
Dr. Burgess. Thank you, Mr. Chairman. I will waive opening
statement and reserve time for questions. Welcome, Dr.
Sharfstein, to our committee.
Mr. Pallone. Thank you.
The gentleman from Connecticut, Mr. Murphy.
Mr. Murphy of Connecticut. Thank you, Mr. Chairman, and
welcome, Dr. Sharfstein.
In your testimony, you recite some of the examples of
safety lapses that we have seen and you summarize by saying,
``These episodes and others are not random mistakes, they are
driven by a common feature, which is economic incentive.'' And
I guess it underscores what we have seen as a facet of our
health care system for a very long time. Too often, profit is
being put ahead of quality and safety, and everything we do,
whether it is changing the way that the FDA works or whether it
is the discussion surrounding health care reform, has to be
around reversing that phenomenon. We have to be putting safety
and quality first, profit and cash second whether it is running
the FDA, whether it is how we reimburse providers or whether it
is how we regulate insurers. I don't begrudge drug companies
from making a buck. We have got a lot of very good ones in
Connecticut. But we should never, ever be sacrificing safety
for profit. We should never, ever be sacrificing quality for
profit. That I think is the guiding principle behind health
care reform and that of course I know is the principle that you
bring to your leadership at the FDA, and I appreciate your
testimony today.
Mr. Pallone. Thank you. The other Mr. Murphy from
Pennsylvania.
OPENING STATEMENT OF HON. TIM MURPHY, A REPRESENTATIVE IN
CONGRESS FROM THE COMMONWEALTH OF PENNSYLVANIA
Mr. Murphy of Pennsylvania. Thank you, Mr. Chairman.
I would first like to mention, unfortunately I am not going
to be able to remain here, Chairman and Dr. Sharfstein,
although I would love to hear your testimony. You know what it
is like, we have other things pending.
But I would like to bring something to your attention in
this, and if it not something you are able to respond to today,
please, I hope you can get back to me. I wanted to tell you
about a couple of my constituents, Russell and Robely Rosewitz
in Mount Lebanon. They have lived a terrible tragedy. Their
daughter, Hannah, was vaccinated for DPT, as you know,
diphtheria, pertussis and tetanus, and 2 hours after she
received her shot, she began experiencing seizures. She was
once a healthy infant and now she needs 100 percent round-the-
clock care. Unfortunately, adverse reactions to complicated
vaccines do occur and years upon years of scientific evidence
have shown the public health benefits of vaccination are
greater than the isolated, unfortunate adverse action. And to
encourage families to vaccine their children and ensure vaccine
makers continue produce lifesaving medicine, Congress passed
the National Childhood Vaccine Injury Act in 1986. This law
compensates victims of vaccination adverse effects and allows
the Secretary of Health and Human Services to automatically
award damages when a victim has experienced adverse reactions.
But the DPT vaccine in this case was removed from the table of
vaccines known to cause adverse events just 1 month prior to
when Hannah's family applied for compensation. After a 10-year
legal battle to prove that the vaccine caused Hannah's
seizures, the case is now before the Supreme Court. Hannah's
parents believe there were safer alternatives to the DPT
vaccine administered to their daughter. The question before the
Supreme Court is whether or not companies are immune to civil
suits if they participate in vaccine victims' compensation
fund.
Now, I am not here to argue the merits of the case. The
Supreme Court will decide whether or not that was the
Congressional intent. But this case raises an important issue
about vaccine safety. For example, if they are imported and the
FDA is not capable of inspecting the manufacturing process,
then where does the responsibility and liability for assuring
safety lie? By the way, that particular DPT vaccine was later
removed from the market after 50 years of sales.
So I hope at some point you can get back to us and let us
know about some of these important issues. I know you are
deeply concerned as are we, and quite frankly, I believe that
contrary to what some others may say, that manufacturers also
want to ensure the safety of their products because they do not
want to see anybody harmed from these as well. so if you could
please get back to us and let us know how we keep up-to-date on
the latest scientific evidence here and how you are ensuring
vaccine makers are using the latest and safest innovation in
vaccine design.
Thank you so much for being here. Again, I apologize. I
wish I could stay because I am deeply interested in hearing
your testimony, but I look forward to hearing from you.
And with that, I yield back, Mr. Chairman.
Mr. Pallone. Thank you, Mr. Murphy.
The gentleman from Utah, Mr. Matheson.
OPENING STATEMENT OF HON. JIM MATHESON, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF UTAH
Mr. Matheson. Thank you, Mr. Chairman. I do appreciate this
hearing and look forward to the testimony.
In the coming weeks, I will be introducing a bipartisan
bill with my colleague, Representative Buyer, to develop a
system for the protection of our Nation's pharmaceutical
supplies for domestic and international counterfeiting threats.
Within the past 2 years, Representative Buyer and I have
engaged stakeholders all along the supply chain to develop a
workable and commonsense approach. As an integral part of the
stakeholder process, I also appreciate the recent helpful
comments from the Food and Drug Administration and their
suggestions of how to improve upon our approach and achieve our
shared ultimate goal.
Specifically, core elements of the bill that we plan in
introducing are the creation of a system by which we will be
able to track drugs from the time they leave the manufacturing
facility to the time they reach patients in the pharmacy,
hospital, nursing home or doctor's office. Counterfeiting of
drugs is a public health concern. By implementing these steps
now, we can go a long way towards safeguarding the medicine
people need to get well and stay healthy.
Another feature will be one uniform national pedigree
system. By having one federal standard, I believe we can ensure
our Nation's drug market is efficient, it can ensure products
flow safely and freely throughout the country. This is a
guiding principle that seems to unite a majority of the members
of the supply chain.
Third, our bill will raise the standards for drug
wholesalers while maintaining States' rights to regulate drug
wholesalers. I believe this is a necessary step to ridding the
market of bad actors and ensuring that anyone handling
America's pharmaceuticals must be held to high standards.
Counterfeit drugs are the latest and potentially the most
dangerous front in the long-running battle against
intellectual-property crimes. In 2007, pharmaceuticals made up
about 6 percent of total seizures. Last year they accounted for
10 percent to become the third largest category with an
estimated market value of $28 million. Counterfeiters are
alarmingly good at their jobs. They can create pills and drug
packages that are so close to real products that they are
indistinguishable to consumers. By strengthening current laws
and regulations, building upon the successful model signed into
law in California, and by creating a uniform national standard,
our legislation further secures the health care supply chain.
This enhances our country's and the Food and Drug
Administration's high standard for patient safety.
I look forward to the witness testimony. I will yield back
my time.
Mr. Pallone. Thank you.
The gentlewoman from Colorado, Ms. DeGette.
Ms. DeGette. I will submit my statement for the record.
[The prepared statement of Ms. DeGette was unavailable at
the time of printing.]
Mr. Pallone. Without objection, so ordered.
I think that that concludes our opening statements by
members of the subcommittee, so we will now turn to our one
witness, which we are so pleased that Joshua M. Sharfstein is
here today. He is the principal deputy commissioner from the
Food and Drug Administration, and thanks for being here, or
coming back to us, so if you would give us your statement, we
would appreciate it.
STATEMENT OF JOSHUA M. SHARFSTEIN, M.D., PRINCIPAL DEPUTY
COMMISSIONER, FOOD AND DRUG ADMINISTRATION
Dr. Sharfstein. I thank you very much. It is good to be
back here. Good afternoon, Mr. Chairman and members of the
subcommittee. I am Dr. Joshua Sharfstein, the principal deputy
commissioner at the Food and Drug Administration. Thank you for
the opportunity to discuss the safety of the U.S. drug supply.
Protecting Americans from unsafe or contaminated drugs is
not just an important responsibility of FDA, it is our core
charge. Drug safety was the primary reason for the passage of
our guiding statute. In 1937, more than 100 people, including
many children, died from ingesting Elixir Sulfanilamide, which
contained the deadly poison diethylene glycol. Congress then
passed, and President Franklin D. Roosevelt signed, the Food,
Drug, and Cosmetic Act to prevent future catastrophes. And yet
as you know, many years later, the threat of unsafe drugs
remains.
I would like to thank the subcommittee for its leadership
on this issue twice. First, thank you. There have been numerous
hearings in this chamber have helped the public understand the
challenge of regulating a global marketplace. And second,
members of this subcommittee, along with the chairman of the
full committee and the chairman emeritus, were the key
architects of the Food and Drug Administration Amendments Act
of 2007, which gave the agency significant new authorities and
resources to address the safety of drugs. In this testimony, I
will cover both of these important issues: import safety and
the implementation of the drug safety authorities in what we
call FDAAA.
Globalization has created new risks and challenges for the
safety of the drug supply. Where Americans once used drugs that
were mostly manufactured domestically, now up to 40 percent of
the drugs we take are imported, and up to 80 percent of the
active pharmaceutical ingredients in these drugs are from
foreign sources. This makes oversight significantly more
difficult and leads to weaknesses through which counterfeit,
adulterated and misbranded products can infiltrate the
legitimate supply chain. That was the case with the
contamination of heparin in 2007 and 2008 and most recently
with the counterfeit Tamiflu discovered during the H1N1
outbreak.
When the modern FDA was created in 1938, imports were a
tiny part of the products used in our country. Now that an
estimated 20 million shipments of FDA-regulated imports come
into this country ever year, FDA must adopt a new approach, one
that addresses product safety by preventing problems at every
point in the global supply chain from the raw ingredient
through production and distribution all the way to U.S.
consumers.
In the food arena, this approach to prevention is embodied
in legislation passed by this subcommittee and the full House
of Representatives, which is now awaiting action in the Senate.
In the area of drugs and other medical products, we are taking
a number of steps to begin making this shift as best we can
with our current authorities. But there is much more to be
done.
As Secretary of Health and Human Services Kathleen Sebelius
noted when she appeared before this committee, FDA needs
additional tools to move our oversight capabilities into the
21st century. FDA needs to access regulatory information
quickly, hold all parties responsible for the quality of
products in the supply chain and have reasonable and reliable
options for enforcement.
I will now turn to the drug safety authorities in FDAAA, a
milestone legislative achievement that has helped the agency
protect the public health in many ways. FDAAA provided
important new authorities to enhance our ability to monitor
approved drugs after they are marketed and to take definitive
action when needed. With our new authority, FDA has required
drug sponsors to conduct around 200 post-marketing studies or
trials. The agency has required safety-related labeling changes
in individual or classes of drugs 32 times and has developed
and put into place 10 evaluation and mitigation strategies with
elements to support safe use into the REMS, all with the goal
of better identifying and managing the risk of drugs on the
U.S. market.
To give you one example, FDA has established a program to
support the safe use of a product, a medication in patients
with a very severe bleeding disorder in which the blood does
not clot because of low platelets. This medication, however,
has serious side effects which include blood cancers, bone
marrow fibrosis, a risk of blood clots, and even worse platelet
counts when the therapy is stopped. However, it is an important
treatment option for patients who have failed to respond to
other therapies. By requiring elements to ensure safe use, the
benefits of the drug can outweigh the risks and we can provide
patients access to this critical product without being
concerned that it would be used in other patients and could
cause them more harm than good.
I also want to know that FDAAA also reauthorized and
amended the Best Pharmaceuticals for Children Act, which
continues to provide valuable safety and dosing information for
the use of drugs in children. As a pediatrician, I echo the
comments of Congresswoman Eshoo, who worked so hard on this
issue. This legislation represents a fundamental shift in
prescribing for the pediatric population, even since the
passage of the FDAAA legislation, 109 labeling changes related
to the use of medications in children. It has been a tremendous
step forward for pediatrics. We are very happy to discuss the
lessons we have learned over the last 2 years in implementing
FDAAA and work together to fine-tune the program.
Over the last 7 decades, so much has changed in
pharmaceutical science and drug regulation, yet in 2007, when
scores of patients died from contamination of medications in
Bangladesh, and in 2006 when children died in Panama, the
culprit was familiar. It was diethylene glycol, the very same
poison that had led to the passage of the Food, Drug and
Cosmetic Act in 1938.
FDA's work is far from done. The scientists, doctors,
nurses, inspectors and other public health professionals, some
of whom are here with me today, who make up FDA thank you for
your support for our mission.
I appreciate the opportunity to testify today and am happy
to address any questions you may have.
[The prepared statement of Dr. Sharfstein follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Pallone. Thank you, Dr. Sharfstein. I appreciate your
testimony. It is good. We are just going to have questions, as
you know, alternating between the Ds and the Rs, and I will
start out.
I mentioned in my opening statement that this committee
worked very hard to pass the Food and Drug Administration
Amendments Act of 2007. We call it FDAAA. And as part of FDAAA,
Congress gave FDA the authority to require manufacturers to
implement the so-called REMS, or Risk Evaluation Mitigation
Strategies. They can require REMS when the agency believes it
is necessary to ensure that a drug's benefits outweigh its
risks. So I wanted to ask you initially, could you provide the
committee with an update on how FDA has made use of this
authority, how many REMS have been required and approved, and
what has been the public health impact of REMS?
Dr. Sharfstein. Sure. There are about 80 or 90 REMS that
have been approved since the passage of the legislation. The
vast majority of those are called medication guide only REMS
where the REMS just consist of the fact that we have a
medication guide for patients about the drug.
There are about 10 REMS for 10 drugs that have what we call
elements to assure safety. This is sort of the next level of
control, and that can include restrictions on which pharmacies
can provide the medication, whether the doctor needs special
training and whether there needs to be a patient registry, and
these have been used for medications for seizures, for the low
platelets that we were talking about before, for medications
for schizophrenia, and they really make it possible for FDA to
approve the treatment because without this ability to put some
restrictions and some safeguards in place, we would be very
worried that these medications could do more harm than good. I
think that this is very clearly a work in progress.
There are certain things that in the implementation of this
provision we have learned about. One of the issues is the
differential treatment between generic medications and brand-
name medications when it comes to communication plans. We can
require that companies that make brand-name drugs do
communication plans for health care professionals but when it
comes to generic drugs, the FDA would have to pay for and run
the communication plan.
So there are a few specific issues, and I am happy to talk
about them more if you want, where we think that we could be
more effective with REMS. One of the others is that we have the
authority to require a REM but we don't necessarily have the
authority to require a specific type of REM, so that leads to
negotiations that can go on for a while between the company and
FDA, and recently we did a REMS for certain medications that
can stimulate the bone marrow that took, you know, over a year
to develop.
So I think that there are definitely areas where this could
be improved but in general our view is that this is a
tremendously important authority and we are really making a lot
of progress with it.
Mr. Pallone. Well, I want to use an example of a drug that
came to my attention, and I heard you say you have the
authority to require REMS but not a particular type, and I
would like you to comment on that. But let me throw this
example out and then I don't know if this relates to what you
said about the type, and I would like you to answer that too so
maybe give me a response to that, what you mean by type that
you don't have the authority but also this example. I am using
as an example that there are three types of fast-acting
Fentanyls, I guess is the way, or rapid-onset opioids, on the
market right now, and I think it is an example where REMS would
be critically important because these are extremely powerful
pain relievers or opioids intended to treat breakthrough pain
in adult opioid-tolerant cancer patients but a dose in a non-
tolerant patient could be deadly. So it is my understanding
that one of these products has a REMS with very different
elements from the REMS that is required of the other two. For
example, the REMS dictates that only especially trained, tested
and registered health care professionals can actually prescribe
the product and distribution and dispensing must be done
through a specially trained and registered distributor and/or
pharmacist. So explain why there would be differences between
the elements of REMS for these three fast-acting Fentanyls, and
does that relate back to what you said before about how you can
only require the REMS but not different types?
Dr. Sharfstein. It does relate back to that, and I don't
think all of them have what we would call formal REMS. Some of
them are sort of in the intermediate stage because they had a
risk management program in place when the Act was passed. But I
think for the purpose of your question, it definitely relates
to what I was saying. The way the law works is, it says that we
need to take steps to assure safe use, and the company comes to
FDA with a proposal on how to accomplish that, and there may be
more than one path to get to that goal. One company might say,
you know, the path that we want to take is to really work
through a series of just a couple pharmacies or a central
pharmacy. Another might want to put particular restrictions on
which physicians so that we have the responsibility of making
sure that they work. We are not going to approve something that
we don't think is going to hit the mark. But they won't
necessarily all look exactly the same.
In the case of the Fentanyl products, there is one that is
for a film that does restrict the pharmacies, and there is
another that is more of a lollipop that you put in the mouth
and that one has an older risk management plan that we haven't
announced the form REMS for.
Mr. Pallone. Well, then, does this difference in authority
make sense to you or would you like to have the power to
dictate the type?
Dr. Sharfstein. Well, I think it is very important for us
to work with companies to come up with something that works
and, you know, there is no question there is a lot we learn
from the inner chains of companies and what we can hear from
others, but I think that it is--when you find that it is taking
a long time to come to agreement and when there may be a level
of consistency that we would like to see if one approach really
makes sense, I think that we would be very open to discussing
ways that we could be able to more effectively move to closure
on REMS in a way that makes sense for public health.
Mr. Pallone. Well, my time has run out, but I have to say,
this is kind of disconcerting to me, the fact that you don't
have the ability to dictate the type and therefore we end up
with these big differences, but I guess we will have to take it
up at another time because I want to move to my ranking member,
Mr. Shimkus.
Mr. Shimkus. Thank you, Mr. Chairman. I am going to follow
up on this line of questions also on the REMS.
So I think the last question was, the time it takes in
negotiations. We see that across the board in the federal
government, and we always say that there should be a stop
clock, a backstop that eventually there is a time when you have
to make a decision. You let the folks negotiate but eventually
you have got to get the closure. Would a backstop provision be
helpful?
Dr. Sharfstein. You know, some of the REMS that we are
putting into place are coming at the time of approval, and
there is a lot of incentive for the company to get its drug
approved, and with REMS, the standard is, we wouldn't approve
the drug without it. So----
Mr. Shimkus. So they have an incentive to get an agreement?
Dr. Sharfstein. Those are happening, but it is when the
drug is already marketed----
Mr. Shimkus. Well, let me go to the generic/brand name. You
did allude in your opening testimony that there is a difference
between your ability to effect, I thought I heard, negotiations
between a generic and a brand name. Can you clarify that a
little better?
Dr. Sharfstein. Sure. That relates to this provision about
communication plans, so one of the things that we can do is
require a company to make certain communications to health care
professionals.
Mr. Shimkus. Why can't that be placed on the generic
producer of the drug?
Dr. Sharfstein. Someone is going to tap me on the shoulder
if I get this wrong, but I think that the law doesn't allow us
to do that for generics.
Mr. Shimkus. So the issue would be a responsibility for us
to address if we are going to move forward to help assist that.
OK. Thanks.
The other question I wanted to talk about was also alluded
to in my opening statement, and in the FDA Week Inside
Washington on January 22nd, on the second page it says, ``As
FDA struggles with whether to relax conflict-of-interest
policies that have made it difficult to fill slots in the
pharmaceutical advisor panels,'' so you all, the FDA, is saying
we have problems filling these slots. We have a tendency, the
unforeseen consequences of legislation, and I think what we are
seeing to some extent is these advisory panels because of which
we can't fill. We pulled up from the Web site gastrointestinal
drug advisory committee where there is five openings that you
all identified. Our office has personal experience with someone
who had a catastrophic death because of this. What do you tell
us and is there anything we need to do ease legislatively? I
mean, the response was to make sure there was no conflict of
interest and people weren't benefiting from their advisory role
while benefiting financially but we have got to be careful that
we don't go overboard and that we lose all this expertise. You
alluded to some of that in your opening statement. What can you
tell us and what advice can you give us?
Dr. Sharfstein. Sure. Well, this is an issue which clearly
requires a balance and it is a balance that Congress faced in
writing the law, it is a balance that the agency faces. On one
hand, we clearly would prefer advisors who don't have conflicts
of interest and it is really important for us to look for
qualified advisors who don't have a conflict of interest. On
the other hand, the agency needs to get the best advice in
order to make the best decisions, and there are certain
situations where the people who have the best advice and unique
expertise are going to have conflicts of interest. We have got
to somehow, you know, balance those two things, and I think the
bill did a very good job and gives the agency some leeway to
figure out how to do that, and within the scope of what the
legislation has done, it gives us the ability to figure out the
right spot, and I will be more specific. The legislation sets a
cap on the number of waivers that we can have for advisory
committees, and that cap goes down over time. I think it is
somewhere in the ballpark of 13 percent. But we are right now
well under that. I think we are granting waivers, like 4 to 5
percent of the people who are on the advisory committees are
getting waivers. So without changing the law, we have the
ability if we think that it is important to get certain members
to grant more waivers. If----
Mr. Shimkus. Well, let me ask a question because my time is
running. On this from the FDA Web site, you have quite a few
vacancies listed there. Now, I don't know what to relate that
to you because I didn't pull up the previous month or I didn't
look at last year's. Is this excessive vacancies? I mean, we
have got anywhere from 21 in one of the areas. Well, in fact,
pharmaceutical science, there are 21 vacancies. Advisory
committee reproductive health drugs, there are eight vacancies.
There are nine in drug safety and risk management. That looks
like there is a lot of vacancies, and if that is, then maybe we
need to----
Dr. Sharfstein. Right. Well, I don't like vacancies on the
advisory committees. We definitely want to fill them. I
actually asked the advisory committee dean whether they felt
that there were more now, and they said that they have always
had vacancies. They couldn't say that there are more now.
Having said that, I think it is important for us to strike the
right balance, and it is not a question for the statute because
the statute gives us more room. If we feel the right decision
is to grant people more waivers, we have got plenty of room
under the statutory cap. It is really up to what the people at
FDA want to do. I think the way Dr. Hamburg and I are looking
at this is, there are situations where it is important for us
to get the best advice from someone who requires a waiver. We
need to take into account the type of conflict they may have,
the type of decision that is being asked for and make a
decision, but we understand that that will be necessary.
Mr. Shimkus. Thank you, Mr. Chairman.
Thank you, Doctor.
Mr. Pallone. Thank you.
Chairman Dingell.
Mr. Dingell. Thank you.
Dr. Sharfstein, I want you to understand these are friendly
questions. I want yes or no answers. You are familiar with the
heparin crisis which caused 81 American deaths. Does FDA
currently have the adequate resources, personnel authorities to
prevent another heparin crisis?
Dr. Sharfstein. No.
Mr. Dingell. Do you have the ability to control the safety
of imported pharmaceuticals?
Dr. Sharfstein. Not to the extent we would like.
Mr. Dingell. Do you have the authority and resources to
address the safety of components now being imported into this
country?
Dr. Sharfstein. No, not to the extent we would like.
Mr. Dingell. Do you have the authorities and resources to
see to it that good manufacturing practices are properly
observed overseas?
Dr. Sharfstein. No, not to the extent we would like.
Mr. Dingell. Would you please submit to the committee the
number of people that you have at the different ports to assure
the safety and the inspection of pharmaceuticals coming into
this country, and also would you give us the number of people
that you need to see to it that this is done? Please submit
that for the record.
Dr. Sharfstein. Sure.
Mr. Dingell. Do you have adequate authority to keep out
unsafe drug shipments at the border?
Dr. Sharfstein. No.
Mr. Dingell. Do you have authority to require manufacturers
to assure the safety of their supply chain?
Dr. Sharfstein. No.
Mr. Dingell. Do you have the authority to see to it that
good manufacturing practices are observed in this country in
both food and drugs and abroad, yes or no?
Dr. Sharfstein. Not to the extent we would like, no.
Mr. Dingell. Does FDA have the authority to require
mandatory drug recalls?
Dr. Sharfstein. No.
Mr. Dingell. Now, do you have authorities, or rather do you
have cooperative management agreements or letters of
cooperation between Food and Drug, the Department of Homeland
Security and other agencies that have personnel at the points
of entry?
Dr. Sharfstein. We do work closely with other agencies at
the point of entry.
Mr. Dingell. Do you have the----
Mr. Pallone. Mr. Dingell, excuse me. Can you speak more
into the mic because I can barely hear you.
Dr. Sharfstein. I am sorry about that.
Mr. Pallone. That is all right.
Mr. Dingell. Do you have adequate authority to require
mandatory drug recall?
Dr. Sharfstein. No.
Mr. Dingell. Do you need that authority?
Dr. Sharfstein. We would like that authority, yes.
Mr. Dingell. Would you like it, or do you need it?
Dr. Sharfstein. I would say we need it.
Mr. Dingell. You have also the legislation down there in
H.R. 759 which gives you additional authorities that was
introduced by Mr. Pallone, Mr. Stupak, Ms. Sutton, Ms. DeGette
and I. That would give you significant authorities to address
your current lack of capability. Is that right?
Dr. Sharfstein. That legislation has some very important
elements, yes.
Mr. Dingell. It would also give you the resources which you
need of a financial character by enabling you to collect fees
from both manufacturers of food and from pharmaceuticals. Is
that right?
Dr. Sharfstein. It does have that provision, yes.
Mr. Dingell. And you can do that both at home and abroad.
Is that right?
Dr. Sharfstein. I believe so, yes.
Mr. Dingell. And are those resources and those fees
included in your budget submissions to the Congress that the
Administration has submitted?
Dr. Sharfstein. I don't believe so.
Mr. Dingell. You don't? I understood they were.
Dr. Sharfstein. I am sorry. For food, it is, yes.
Mr. Dingell. For food?
Dr. Sharfstein. Yes, for food.
Mr. Dingell. How about pharmaceuticals?
Dr. Sharfstein. I don't believe so, no.
Mr. Dingell. But that is built into your budget with regard
to food?
Dr. Sharfstein. Correct.
Mr. Dingell. Now, it is a curious situation that I have
observed that you were in the awkward place at Food and Drug of
having somebody being able to bring unsafe foods into the
United States and you can't catch them at the point of entry.
But you also have the problem if you do catch them, you don't
have authority to seize, impound or to destroy. Is that right?
Dr. Sharfstein. Yes.
Mr. Dingell. So you send them back out. That is right?
Dr. Sharfstein. I believe so. Often that is what happens.
Mr. Dingell. And they then bring them back in. Is that
right? Through another port of entry.
Dr. Sharfstein. I think they can try, yes.
Mr. Dingell. Do you have that same problem with regard to
pharmaceuticals?
Dr. Sharfstein. Yes.
Mr. Dingell. So that problem exists in both places. Now,
you have problems with unsafe commodities being brought in,
foods and pharmaceuticals, and you also have some that are
overaged, improperly stored, contaminated, filthy, improperly
packaged, counterfeit, and you also have some that are full of
inert substances. You mentioned talcum powder and things like
that coming in. Do you have authority to deal with those?
Dr. Sharfstein. We have some authorities but not enough.
Mr. Dingell. Do you have enough?
Dr. Sharfstein. We don't have enough.
Mr. Dingell. As proven by heparin.
Dr. Sharfstein. Yes.
Mr. Dingell. And of course, you have coming into this
country from China on a fairly regular basis, from Mexico and
other places, unsafe foods and pharmaceuticals and I can recall
mushrooms, I can recall berries, I can recall tomatoes and
jalapeno peppers. I can recall the heparin scare and a large
number of others. This an ongoing and continuing problem, is it
not?
Dr. Sharfstein. Absolutely.
Mr. Dingell. And you lack the Congressional support in both
authority and money to do the job that you need to do to
protect the American people. Isn't that right?
Dr. Sharfstein. Well, we very much want to do more.
Mr. Dingell. I don't want you to be afraid to say that we
haven't given you the authority you need----
Dr. Sharfstein. We want more authority.
Mr. Dingell [continuing]. If it is the truth because we are
going to try and get it for you.
Mr. Chairman, I thank you for your courtesy.
Mr. Pallone. Thank you, Mr. Dingell.
The gentleman from Pennsylvania, Mr. Pitts.
Mr. Pitts. Thank you, Mr. Chairman. Going back to this
concern for counterfeit drugs, there is a growing global threat
from counterfeit medicines. For example, in 2008, counterfeit
medicine article seizures rose 118 percent in the European
Union, and 8.9 million counterfeit medicine articles were
seized by E.U. customs officials. Over just a 2-month period in
2008, the European Commission seized 34 million counterfeit
pills including antibiotics, cancer, cholesterol and
antimalaria medicines. Does this staggering increase in
counterfeiting in places like the E.U. present concerns to the
United States, and can you quantify it for us?
Dr. Sharfstein. It definitely does present concerns, and I
think, you know, the problems with counterfeit products, first
of all, they can be dangerous in and of themselves, but second
of all, they can fail to treat the condition that the patient
has and the patient can get much sicker if they are taking
medicines that are ineffective or subpotent. So it presents a
serious problem and I think the problems that we see globally
are very much a potential threat to the United States.
In terms of quantifying, I can't unfortunately quantify how
many counterfeits are in the United States. We do that reports
that we have been investigating have gone up over the last 2
years so that our investigators at FDA are hearing about this
problem more, but we do think that in general we do not have a
huge problem with counterfeit in part because we have a
closed--a generally closed system. When pharmacies order
medications, they can get them through licensed wholesalers,
they can get them from licensed manufacturers, but we know that
there are ways for other products to enter the legitimate
supply chain and that makes us concerned. You may remember in
2003 there were several million, I think, pills of Lipitor that
were counterfeit that got into pharmacies, and there are other
problems too. Recently we had a situation where a truck full of
insulin was stolen and then the insulin started showing up
later, and we didn't know whether the insulin had been
adequately refrigerated and it had sort of reentered the supply
chain in a way that could potentially have been quite dangerous
to patients. So there is no question that the problems seen
around the world are of concern to us and we think that we do
need additional work here to really secure the supply chain in
the United States against this potential threat.
Mr. Pitts. When the U.S. authorities interdict counterfeit
drugs here in the United States, what occurs? What is done with
those drugs?
Dr. Sharfstein. When we actually find the drugs and we know
that they are counterfeit? I am not sure, but I think they are
destroyed. If we identify products that are, you know, in the
supply chain that are counterfeit, I can double check, but I
think they get destroyed.
Mr. Pitts. Where are the major gaps, in your opinion, as
far as interdiction of counterfeit drugs here in the United
States?
Dr. Sharfstein. The major gap is that we don't require a
pedigree for the product to go all the way from the
manufacturer to the final sale. If people are ordering from the
right places, they can get medicines that are safe and not
counterfeit. There are opportunities for counterfeit products
to potentially get in without a clear requirement where we are
holding each person in the chain responsible for making sure
that they only have legitimate products. So the kind of
provisions that we would like to see are that each person in
the supply chain as it goes from the manufacturer to the
wholesaler, they are responsible. If they let something in that
is not legitimate, then there is a real penalty for that and
every single person in the supply chain, every single company
is responsible for making sure those products are legitimate,
and that would require a new authority.
Mr. Pitts. Do you have a regular system or procedure for
testing drugs that are coming in the United States that you
pursue?
Dr. Sharfstein. We do do some tests. We do some targeted
sampling based on where we think the risk is but it is really
only a small part of the solution, the testing. There is no way
we could test our way out of the problem just because of the
sheer volume of imports.
Mr. Pitts. What is the greatest need that you have as an
agency as far as addressing this problem?
Dr. Sharfstein. I think the greatest need is the ability to
enforce the supply chain requirements across the supply chain.
You know, we have been working on and are about to come out
with a process for unique numbers for each kind of bottle of
pills but we don't have the authority to say you are
responsible for making sure that every person when they get the
medication that it is legitimate medication. That is what we
would like.
Mr. Pitts. Thank you, Mr. Chairman.
Mr. Shimkus. Would the gentleman yield for one second?
Mr. Pitts. I will yield.
Mr. Shimkus. But that discussion was all about the legal
distribution chain. You haven't even addressed the illegal Web
sites and the illegal mail order sites that if some senior goes
on a Web site, clicks on 90-day supply of Lipitor and it gets
mailed to them, there is no way. We don't know. Is that
correct? I mean, that was a good discussion about legal
process, of all the good actors. I think the concern that most
of us have is the bad actors.
Dr. Sharfstein. We have brought some cases recently against
bad actors and legitimate chain and the ability of products to
infiltrate the legitimate supply chain is something that we
need to be very vigilant about, but you are right. You are
raising a separate issue that is very important and I think
this gets a little bit to the issue that Congressman Buyer and
Congressman Matheson were raising about destruction authority
and other things, and that is also an issue that we care about.
Mr. Shimkus. Yes, and I only bring it up because there is
really--I agree with your statements but I think for both of us
it is that other issue that has us more concerned than
anything.
I appreciate the gentleman yielding.
Mr. Pitts. Thank you, Mr. Chairman. I yield back.
Mr. Pallone. Thank you.
The gentlewoman from the Virgin Islands, Mrs. Christensen.
Mrs. Christensen. Thank you, Mr. Chairman, and thank you
for holding this hearing, and welcome back, Dr. Sharfstein.
First of all, I can attest to the fact to the answer to
Chairman Dingell's question about collaboration with other
agencies because Customs and Border Protection acts on behalf
of FDA at the Puerto Rico transit station--and your staff knows
where I am going, I can see them nodding--to confiscate
medication going to and from the Virgin Islands, but I am not
sure if you are aware of this problem but I have to bring it
up, and your staff is aware of it. We are outside of the U.S.
customs zone. We are fully part of the United States. We are
outside of the U.S. customs zone. All of our pharmacists are
U.S. trained, and while they are locally licensed, they have
their U.S. DEA license and are governed like the Virgin Islands
are in general by all the U.S. laws and they are governed by
all FDA rules and regulations. They order their medication
including my hospital pharmacies, which are also overseen by
JCAHO and CMS. They order their medication from distributors in
the States. These are either U.S.-made medication or something
that FDA has approved for importation into the United States.
They cannot send it back to their distributor. They are
prohibited because we are outside of the customs zone from
sending it back to their distributor if they are oversupplied,
if they are damaged, if they are expired. It is an extreme
burden on my pharmacies. My hospital pharmacies were cited by
one of the certifying agencies for having too many expired
drugs in the pharmacy.
If we could craft some narrow language, and we have tried,
that would just allow our pharmacies to send their medication
back to the place that they brought it from, would you be
willing to take a look at that?
Dr. Sharfstein. Absolutely, and I do recall your raising
this issue before and I know that there are people at FDA who
have been actually in touch with entities in the Virgin Islands
to work on this.
Mrs. Christensen. Yes, we have had some conference calls.
Dr. Sharfstein. So I am extremely sympathetic to the
situation that they were in and I think we would like to find a
solution.
Mrs. Christensen. I appreciate that. And the other question
is about importation. Well, I don't consider ours importation
or reimportation of drugs because they are U.S.-made drugs,
U.S. pharmacies, it is U.S. jurisdiction. But Congress and FDA
acknowledge that there have been numerous safety issues related
to drug importation, and I voted against it when I had the
opportunity. One of the issues I am concerned about from a
safety perspective is the importation of products subject to
the REMS requirements that have been discussed in other ways
here today. Does the FDA support this posture that they can be
reimported subject to the REMS requirements, and how does FDA
view the reimportation safety concerns as they relate to the
REMS process? And would FDA ever under any circumstances
consider an exemption of certain drugs under reimportation
policy if it would lead to the obfuscation of the REMS
requirements? Is that clear?
Dr. Sharfstein. I think I understand. You know, the
Administration supports finding a safe and effective way for
patients to obtain medications from other countries but it is a
challenge because there are a lot of safety concerns, and
certainly one of the safety concerns that would have to be
overcome is trying to figure out what to do with the products
that have a narrow therapeutic window. Another way of saying
that, where you are worried that they could actually do more
harm than good where you have a REMS in place or other
medicines where it depends on how they are used, and that very
much would be an issue for us, I think, and we would not want
people to get medications without the kind of controls that are
needed to ensure their safe use.
Mrs. Christensen. Is there something that we need to do to,
or is there something the improvements that need to be made or
becoming more assured of the safety and use of the REMS
process? Is there something that we need to do? Is there
something that FDA can do administratively?
Dr. Sharfstein. I don't think there is an issue before
Congress on this point right now, but if there is, we can be in
touch. But I think the premise of your question that there are
certain drugs we have to be very careful about, that does
underlie FDAAA and that is something that FDA feels very
strongly about.
Mrs. Christensen. Thank you.
Thank you, Mr. Chairman.
Mr. Pallone. Mr. Burgess.
Dr. Burgess. Thank you, Mr. Chairman, and again, Dr.
Sharfstein, thank you for being with us and staying with us
late this afternoon.
On the issue of resources, we have heard I don't know how
many times in this committee and the Subcommittee on Oversight
and Investigations about inadequate resourcing of the agency
and that the resources haven't kept pace with the increase in
demands placed on the FDA, the fact that now you are having to
really function as almost a global agency with budgets that 10
years ago seemed adequate but now you seem significantly
underfunded. It always happens. In fact, I was on this
committee for several years before I realized that the funding
actually comes from the USDA appropriations bill, not through
HHS. That funding structure something that you all have to deal
with but should we consider some way modernizing how Congress
funds the FDA?
Dr. Sharfstein. You know, I think over the last few years
FDA has gotten a tremendous amount of new resources and the
subcommittees, both of which I testified at last year, were
extremely supportive of the agency, and the agency really has
been using those resources to develop a real foundation for the
future on these issues. I think that it is not just resources
that are an issue when it comes to an issue like safe drugs and
imported safe drugs. We need to be able to secure the supply
chain, hold people in the supply chain accountable, set good
standards----
Dr. Burgess. I don't mean to interrupt you, but I will run
out of time here.
Mr. Chairman, if you will just make note that the witness
testified that they have all the money they need and Congress
does not need to supply any more.
But it begs the next question, and I know it is a drug
safety hearing, but you must get a tremendous volume of new
drug applications. Is that correct?
Dr. Sharfstein. I think that there is a tremendous amount
of work when it comes to the new drug applications and
additional indications for existing drugs, so there are a lot
of different types of applications that the agency has to
handle, yes.
Dr. Burgess. Do you have any idea as to the magnitude of
the backlog?
Dr. Sharfstein. Well, there is not really a backlog when it
comes to the new drug applications. We are on a clock and we do
our best to hit the goals of reviewed timetables. When it comes
to generic drugs, there is a backlog. It is a different type of
review process, a different type of application, and there are
several thousand applications that are kind of in the queue to
be approved.
Dr. Burgess. Well, for example, we got funding for the
National Institute of Health in the stimulus bill, a
significant amount of money, and the idea was, of course, to
generate new research and new discoveries. Do you have what you
need to keep pace with the rapidity of those new discoveries
and new developments?
Dr. Sharfstein. That is an excellent question, and slightly
different than just reviewing the applications. I think that
FDA, and Dr. Hamburg has been very engaged on this issue. We
feel that the agency needs to do a lot more to be able to
review the products of the 21st century, and that involves
updating and upgrading our scientific standards for review and
it involves a lot of needed investments, not just by the
government but by academia and others, in what we call
regulatory science, which is the science of how you know
whether something is safe and effective. For example, we want
to be able to identify a safety problem very quickly in the lab
and not have a company spend all this time and money in
development and then find the safety problem; let us identify
that quickly. If there is a way on the effectiveness side to
find a marker that a drug will be effective without having to
require a tremendous and long amount of time before we show
that it works, that is just an enormous benefit to the drug
development process, and that is separate from the review of
any one application but that area of regulatory science and
those kinds of investments are extremely important. The
President's budget for the first time has an initiative on that
but over the course of the future this is where we think that
there needs to be a lot more done.
Dr. Burgess. Well, just as a case in point, a real-world
example, yesterday the Alzheimer's association was on the Hill
visiting every office asking for a significant plus-up in
funding for Alzheimer's research, a noble goal, a worthwhile
goal. This comes on top of the reauthorization we did at NIH
back in 2006, level funding of $30 billion a year to increase 5
percent a year. I don't know that we have ever met those goals.
But then the $10 billion in addition to the authorized amount
that we gave in the stimulus bill, now we are asking at least
in the Alzheimer's legislation that Mr. Markey has, another $2
billion to put forward to the research for new Alzheimer's
drugs. Can you guys keep up with that if you have that kind of
push in the pipeline for new products coming down?
Dr. Sharfstein. I will tell you the analogy that Dr.
Hamburg uses when she talks about is of a rower with one very
muscular arm and one kind of scrawny arm, and if we are pouring
a lot into basic medical research but we don't have the science
to decide whether the products are safe and effective, then you
don't get a system that moves forward. It kind of goes in
circles. You don't see the treatment----
Dr. Burgess. And are you aligning yourself to that, to
making a more muscular----
Dr. Sharfstein. Yes. And in fact, a few weeks ago,
Secretary of Health Kathleen Sebelius went out to NIH with Dr.
Collins and Dr. Hamburg and we announced a whole set of
collaborations with NIH to bridge the gap so that it is not
that money goes to NIH and then here is FDA on the other side
but that we are going to have in addition to a public meeting
and open docket for suggestions on how we can work together, we
can have a council that is going to meet and oversee a whole
new range of collaborations, and for the first time both
agencies are putting in money to fund this kind of research in
academia around regulatory science.
Dr. Burgess. But at the present time, to the extent that
those new discoveries are arriving on your doorstep, there is
no backlog? Those applications are receiving timely review
and----
Dr. Sharfstein. It is not a question of the timeliness of
the review, it is the tools we have. We would like to upgrade
the tools we have for the new types of products.
Dr. Burgess. Are all those applications online? Is that all
in an electronic database?
Dr. Sharfstein. We are moving towards full electronic
submission but the problem is----
Dr. Burgess. So the applications are paper applications?
Dr. Sharfstein. In some cases, but I think we are moving
pretty quickly to electronic, but I think the issue is----
Dr. Burgess. But, you know, here, and I will just give you
a real-world example. If this were a class-action lawsuit, for
example, a big law firm, any of the big law firms downtown or
in downtown Dallas would hire the people to digitize that data
and then have it done within a couple of months' time in order
to make their case either pro or con in the legal action. This
is something that is done all the time but outside
organizations. The FDA should be the leader on this.
Dr. Sharfstein. There is no question that we need to have
electronic data submissions, and we want to do it in a way that
the data comes in so that it can be analyzed very efficiently.
The challenge is, it is not so much the review of the
application that comes in, it is that we don't get the
applications, products don't make it all the way to the point
where they have enough evidence to get to FDA's doorstep. That
is the kind of gulf we are trying to cross by working with the
NIH, that they do the research, they go, oh, maybe this product
works. Then how do you get it from there to the point where you
can do clinical trials? I mean, how do you--what is the right
kind of clinical trial to do, what is the right tool to know,
how do you get the companies in, ready to invest.
Dr. Burgess. And after companies have made that investment
and they come to you for the approval, that is the part of the
chain that I am worried about, that you have the tools you need
to be able to get these things to the people who so desperately
need them.
Dr. Sharfstein. I agree with that completely, and we also
want more drugs to come to our doorstep than are coming now,
more applications. We would like to see that happen because
there are a lot of people who have diseases that need medicine.
Dr. Burgess. I don't know what time frame would be the
correct unit, but how many new drug applications per month or
quarter or fiscal year?
Dr. Sharfstein. I think it is a ballpark of about 25 new,
completely new drugs getting approved by the FDA roughly every
year.
Dr. Burgess. How many applications, though, how many new
drug applications that seek approval will you get a year? So 25
make it through the----
Dr. Sharfstein. This is Dr. Woodcock from FDA. About 30 to
35. You know, that is my point about we would like to see more.
But to do that, we have to help the discoveries bridge the way
to the point of FDA application.
Dr. Burgess. Interestingly, Dr. Zerhouni at NIH 8 years ago
told me that they were working on, I think it was no fewer than
88 drugs to deal with obesity. With that kind of pressure in
the research pipeline, you guys are going to have to be really
precise and efficient to be able to handle that kind of
research coming in your direction.
Dr. Sharfstein. I think that is true. What we want to do is
help NIH as it is investing in those 88 or however many it is
products, pursue that investment so it is pushing the products
closer to an FDA application rather than, you know, being all
these different steps to get there. And so that is one of the
things we are going to work with them on. If NIH is going to
pay for a trial, what is the right way to design that so that
we get really good usable data for an application. So it is not
so much once the application comes in, we need better tools to
review them, but it is how you get more applications of
promising therapies. That is what Dr. Hamburg is extremely
committed to and why we are doing this big product with NIH.
Mr. Pallone. Dr. Burgess, we are actually going to have a
second round, so I just want you to know.
Mr. Braley.
Mr. Braley. Thank you.
Dr. Sharfstein, I want to start with a word that we hear
still today frequently called mail order drugs, and in this
Internet age, isn't that somewhat of an oxymoron? There is a
very specific reason I am asking you this question. We heard
our colleague Dr. Gingrey spend his time that he had in his
opening instead of talking about drug safety blasting the
health care legislation we are considering right now. But when
you have 47 million Americans without access to health
insurance and a lot of people losing their jobs with employer-
based health care coverage and you have got people who are in
prescription drugs who suddenly have no means because they
can't afford to pay their COBRA payments without a job who go
online like many of us and surf for some answer to their
medication needs. There are endless Web sites out there of
predatory companies looking to see what may or may not be an
actual pharmaceutical to somebody desperate for treatment.
Would you agree with that?
Dr. Sharfstein. I think it is a recipe for tragedy.
Mr. Braley. And we all know that the problem is, your
agency has limited resources you are dealing with. Research
applications, you are dealing with enforcement issues overseas,
you are dealing with enforcement and compliance in domestic
manufacturers. So I guess my question is, if we do nothing to
improve access and affordability for prescription drugs, aren't
we just inviting chaos as consumers look to these disreputable
online companies, and I am not lumping all online companies
into that category but there are plenty of them out there.
Aren't desperate people going to resort to desperate measures
to try to solve their health care needs?
Dr. Sharfstein. I think there is no question that health
care reform that gets more Americans access to prescription
drug coverage is extraordinarily important for avoiding the
kinds of problems we are talking about.
Mr. Braley. Thank you. One of the things that I wanted to
talk to you about was your remarks about the Sentinel
Initiative because I am interested in learning more about that,
what it was based upon, what model it was based upon and how it
is going to achieve the objective of a national integrated
electronic system for monitoring medical product safety. And
Dr. Christensen mentioned JCAHO, which is looked to by many
people as a forerunner in setting up a Sentinel Event Reporting
System with root cause analysis and an integrated approach to
trying to get to the bottom of patient safety issues. In its
first 10 years of existence, the Sentinel Event Reporting
System averaged annually 300 reports, which is an abysmal
statistic given the high number of medical errors that occur in
this country every year. So tell me how this Sentinel
Initiative that FDA is pursuing is going to achieve the
objective and the access data goals that you have identified
and truly reach a comprehensive reporting system that is going
to get to the heart of patient and drug safety?
Dr. Sharfstein. Sure. I appreciate the question. What we
are doing and the sentinel system at JCAHO are very, very
different. They have the same word but they are very, very
different. They are, I think what you are describing is sort of
a reporting system where people actually have to report. That
is not what the FDA's sentinel system is based on. The concept
is that there are data resources out there, generally large,
integrated health systems, where you have data for millions of
Americans who are taking medications and that we can use that
information in a way that is completely protective of their
confidentiality. In fact, the data we are looking at doesn't
come to the federal government, it is done by the systems
themselves. They look into their system to answer key questions
about drug safety and over time we put into place a system to
look in advance. In other words, if we have a concern that a
particular product might cause a problem, we can program it so
that if we see that when patients are getting it, it
automatically lets us know. That is the long-term goal. So----
Mr. Braley. Let me just interrupt you briefly to add
another component to this, because my time is running out.
There has been a big push not only in the American Recovery and
Reinvestment Act that we passed earlier in 2009 but also in
this health care bill that we have been talking about to move
aggressively toward electronic medical records, which we all
know is one way to try to deal with drug interactions and to
dramatically reduce the number of drug errors. So is that
another reason why getting it right on EMR is so important in
addressing some of the goals of this Sentinel Initiative?
Dr. Sharfstein. Absolutely. If we have more patients with
effective medical records and we are working with the Office of
the National Coordinator to make sure the standards on those
records are good for this kind of work, then we will be able to
tap into more Americans' experiences with medications to
identify whether there are legitimate safety issues that we
have to respond to. So where we are now if that we are working
with certain health care systems that have data and we are
setting up basic standards so that they will be able to respond
to inquiries. It is a system where we don't need anyone to
volunteer anything. Once we have a question, they go out and
they just program their data set and they tell us whether they
are seeing that, and it is a network so it is not just one big
database. It is, you know, we are going to go up to New England
and there is a data set there, there is a data set in
California, and we are going to be able to look in a much
quicker way than we can do to see if there are safety signals
emerging. And there has been a lot of work done at FDA. We are
constantly reviewing how this is going to make sure we are
keeping it on track. It is a very ambitious project but there
has been a tremendous amount of leadership at the agency on it
and we are very appreciative of the support we have gotten.
Mr. Braley. Thank you. I will yield back, and I would just
encourage you to keep us informed on the progress you are
making in the rollout of that system.
Dr. Sharfstein. Sure.
Mr. Pallone. Thank you.
The gentleman from Kentucky, Mr. Whitfield.
Mr. Whitfield. Thank you very much.
I have a relatively simple question. As you continue to
work and develop the REMS program, and I had mentioned in my
opening statement about NASPER, the national prescription drug
monitoring system. I was curious, have you yourself worked or
your agency worked very much with the DEA or SAMHSA in
implementing this national prescription drug monitoring system?
Dr. Sharfstein. It is an excellent question, and that
system is primarily dedicated to the schedule drugs, and we
have been having some public meetings about how to ensure the
safe use of certain schedule drugs that have very important
medical uses. They are long-acting opiate medicines. You know,
our reach in the REMS program goes really to the manufacturers
and what they can do, but we are very aware that there are
other key players and we have been in discussions with DEA and
others to try to figure out what the right balance is. We
clearly know that patients benefit from pain relief and it is
extremely important. On the other hand, we don't like to see
the fact that patients can die of unnecessary overdoses or
there can be diversion. So it is a combination, and we have
some tools to put on the table to help with this balance and we
are very aware that the other agencies do and the prescription
drug monitoring program is very much part of the discussion.
Mr. Whitfield. Well, I appreciate that, and of course, REMS
is designed to minimize risk for patients and certainly that is
the same goal of NASPER as well to give the health care
providers more information. So I hope that you all will keep
that in your minds as we move forward on trying to obtain
adequate funding to fully implement NASPER.
Dr. Sharfstein. Thank you. That is an excellent point.
Mr. Pallone. Dr. Sharfstein, you describe in your testimony
the importance of moving from a reactive approach to drug
safety problems to one that prevents such problems from
occurring in the first place. Obviously prevention is what we
are all about in every aspect of health care. As you know, the
committee worked very closely with the FDA to develop and pass
the Food Safety Enhancement Act this past summer. We are now
waiting and waiting for the Senate to pass its version, which
we hope will be very similar to our bill. I understand they did
pass a bill out of committee. In my view, one of the most
critical components of the food safety legislation was giving
the food industry more responsibility to ensure the safety of
their foods and giving FDA more authority to ensure the
preventive safety controls are in place, and you mentioned this
provision in your testimony and stated that FDA is taking steps
to begin making this kind of shift within your current
authorities. And what I am trying to understand is whether your
current authorities are adequate to accomplish this.
The Food and Drug Administration Globalization Act of 2009,
that is the bill that was developed by Mr. Dingell, myself, Mr.
Stupak and others, and that contains a similar provision to
that in the food safety bill. Specifically, section 204 of that
bill would require drug companies to develop and implement a
quality risk management plan to incorporate risk identification
and control into the production processes. The plan would, for
example, require the company to assess the competence of
potential suppliers of raw materials or ingredients. It would
also require the company to conduct periodic onsite audits and
carefully monitor the safety of drug ingredients, and this plan
would be available for FDA review during inspections. So what I
am trying to find out is whether you think this approach is
workable and necessary for drugs as we did for foods, and would
it help FDA's efforts to shift to a more preventative-based
drug safety system if the agency had that kind of enforceable
authority?
Dr. Sharfstein. Thank you. It is a great question, and it
is in fact true that the same principle that underlies the food
safety bill and a lot of the authorities that is needed in the
medical product arena also. We do think that new authorities
are going to be necessary for FDA to have confidence in the
preventive-oriented approach. Right now, FDA inspectors are at
the border under a legal standard that we can hold something if
there is an appearance of adulteration, but we can't require,
we don't have access, because we can't require people to have
current registration for, you know, just those facilities that
they are making. We can't require them to present information
about their products meeting key safety standards like having a
preventive plan in place. And so we are not operating under a
paradigm that is really focused on prevention, and we would
like to make that shift and there are definitely elements in
the bill that would accomplish that.
Mr. Pallone. I appreciate that. When we did this
Globalization Act, we had the four areas you mentioned, medical
devices, there is also cosmetics, and of course ultimately we
would like to develop legislation or pass legislation for all
four, but we separated out the food safety because we were
making more progress and we felt that that was the most likely
that we could move. But now we want to move to certainly deal
with the drugs and ultimately with the others as well. So I
just ask that you--you know, I know that you provided a lot of
help to us as we developed the food safety legislation. We
would like to have the same cooperation and help as we move
towards drug safety and the others.
Dr. Sharfstein. Well, we really appreciate the
subcommittee's leadership in this area.
Mr. Pallone. Thank you.
Mr. Shimkus.
Mr. Shimkus. Thank you, Mr. Chairman.
This is a good line of questions and debate and
instruction, so I am glad we are going down this route. I want
to go back. We were involved with the legislation that is
pending over on the Senate side now and so it is a template for
where we want to move but we need to get some clarification.
Does the FDA have tools at its disposal to have a company take
its drug off the market? Do you have the tools right now?
Dr. Sharfstein. There are mechanisms for FDA to have
drugs--you mean if a drug is unsafe?
Mr. Shimkus. Right.
Dr. Sharfstein. Yes, there is a process for that.
Mr. Shimkus. So we do have the tools?
Dr. Sharfstein. If there a safety problem with the medicine
so it is no longer safe and effective, yes, there is a process
for that.
Mr. Shimkus. And so in the past years you have asked drug
companies to take drugs that are identified as being bad off
the market, have you not?
Dr. Sharfstein. Yes.
Mr. Shimkus. Has any company ever refused to do so?
Dr. Sharfstein. I have to go back, but not that I know of.
Mr. Shimkus. There has been----
Dr. Sharfstein. I shouldn't say not that I know of. I think
we would have to get back to you because there may be some
examples of that. But I think that you have to distinguish
between--there are two things. One is the products and the
other is the manufacturing, whether there are manufacturing
issues that could come up as well.
Mr. Shimkus. A follow-on question, because we really want
to drill down because we know you have got the ability to do--
we just don't want you to say boom, here is all this new stuff
if there are things that are doing successfully now. We don't
want to create multiple additional new levels of bureaucracy,
we want to build on what is working now. And so that is why we
want to be very specific with our questions.
Dr. Sharfstein. Sure. The one thing I would say is that it
is important that, you know, there may a process to accomplish
something but if that process is so burdensome and time
consuming, it may not be fully protective of public health. So
as we get back on these things to provide technical assistance,
it may be that, yes, there is a process but we would like a
better process, a simpler process that can be more effective.
Mr. Shimkus. In your response to Chairman Dingell, you
stated that you needed additional authority to require
manufacturers to implement quality risk management plans. And
the follow-up question is, do you actually need this authority
or is that something you can do now? Could you just incorporate
this into your good manufacturing practice regulations?
Dr. Sharfstein. We feel like we would need the authority.
Mr. Shimkus. I think we need to talk more.
Dr. Sharfstein. I am always happy to talk more, but I think
that we----
Mr. Shimkus. That is the whole thing. When we move
legislation, we are going to get more specific. You can help
educate us and we are going to be getting you all the resources
you need.
Dr. Sharfstein. They are very different, and it is similar
to the food safety language, because even though there are food
GMPs that we get authority that the food safety to set
preventive standards.
Mr. Shimkus. But having been in the room on that, we struck
a good balance, that we didn't go overboard and that we brought
industry at the table so that we didn't duplicate things.
Dr. Sharfstein. I agree.
Mr. Shimkus. And that is where we want to be very, very--
because we want to be helpful. We don't want to be harmful. We
don't want to create such--and we talked about this gap. You
talked about really this gap from NIH to FDA, and you know what
ties the companies over to continue to develop these new drugs,
and that is the certainty that if they are successful, they
have a patent and they have a return on that investment. And of
course, we are always attacking that patent. We do want to
attack--I have always been in the position that when they game
the system and extend that, but I have always supported these
folks who are taking the risk all these years, that gap, the
only thing that keeps them going is that assurance that there
is going to be a return on that investment based upon at least
some period of time where they have exclusive rights to sell
that drug. Isn't that correct?
Dr. Sharfstein. I think it is very important that companies
have some protection.
Mr. Shimkus. And I am going to end on this as far as my
line. I do appreciate this. As we move forward, I have great
respect for the chairman of this committee. There are times
that we have agreed and we worked well together and there are
times when we fought and we still are friends. And so I look
forward to both times as we move forward.
But I also want to be careful, and I am also on the high-
tech committee here and I understand the benefits of digital
records, and we are always going to fall into this concern on
privacy and the collection of data, and it is a tough balance.
So when we hear words about collecting data, information on
personal records that help us do something, I think that is
going to be easier said than done.
Dr. Sharfstein. Right. And just to be clear, what I was
talking about, the sentinel system, there is no personal data
at all that comes to FDA. It is done by the health systems
themselves, the studies.
Mr. Shimkus. I am just telling you, most data breaches are
people stealing data and----
Dr. Sharfstein. It is a very serious issue----
Mr. Shimkus [continuing]. Selling it with flash drives and
stuff, so thank you, Mr. Chairman.
Mr. Pallone. Thank you.
The gentleman from Texas, Mr. Burgess.
Dr. Burgess. Thank you, Mr. Chairman. This is a good
hearing and a good discussion. I hope we actually have an
opportunity to have a similar discussion regarding medical
devices at some point in the future because they deserve no
less of our scrutiny.
Dr. Sharfstein, I wasn't in the room when Mr. Dingell was
asking questions, but some of them have been sort of
reintroduced now by Mr. Shimkus. On the border authority--we
all remember the story of the tomatoes a couple years ago and
the unfortunate discovery at 5:00 on a Friday afternoon that it
was Mexican peppers that were causing salmonella outbreaks that
had riveted the news shows for the whole summer, but the FDA
lacked the authority to actually stop the importation at that
point. Have you identified the authority that you need there to
keep this occurrence from happening in the future? Are there
things you need from us to be able to have that authority if
you have identified the authority and you lack it?
Dr. Sharfstein. With respect to food particularly?
Dr. Burgess. Particularly with respect to food, but we are
going to get into some of the pharmaceuticals in a minute.
Dr. Sharfstein. There is no question we need more authority
because we want to shift to prevention. We need to be able to
see----
Dr. Burgess. So can you identify for us specifically what
that authority is that you need?
Dr. Sharfstein. Well, I think that that is where we worked
with the committee on the legislation that is hopefully going
to pass, is going to address that gap. There are sections that
relate to what is required to import food.
Dr. Burgess. And is the language in the bill that Mr.
Dingell said was languishing safely in the Senate, is that
language enough? Is it going to provide you enough of the
authority of what you need to have?
Dr. Sharfstein. Yes, we support that legislation because it
is going to be an enormous step forward for how we can assure
the safety of imported food and domestic food.
Dr. Burgess. So any changes that occur over the other body
then would need to be scrutinized pretty carefully to make
certain that they didn't strip away the authority that you have
identified that you will need?
Dr. Sharfstein. Well, there is no question. All these
provisions are extremely important, and it is very important
that, you know, we look at all of them as they get modified in
the legislative process.
Dr. Burgess. Another story that really just riveted the
headlines 2 years ago was the Chinese heparin story. What has
happened? We had a hearing I think in April or May of 2008. It
hasn't really been in the news stories. What is happening in
that investigation now? Is there anything new that has come up
from your looking into the manufacturer of the isolation of
heparin overseas? Are we still importing the active
pharmaceutical ingredient from overseas? Where are we with
that?
Dr. Sharfstein. There is certainly a huge level of import
from China for heparin. What has really happened since that
time is after the source of the problem was identified, there
was a new standard written for heparin that has been adopted by
companies and regulators around the world. It has been
incorporated into the USP, which is sort of the standard-
setting body, so that now--previously it wouldn't have caught
the problem, oversulfated chondroitin sulfate.
Dr. Burgess. Right. It was a clever contaminant to hide
behind.
Dr. Sharfstein. Right. Much cheaper than heparin, but
evaded the tests, went below the radar. FDA played a critical
role in identifying how you can find that contaminant,
demonstrated that when you add that contaminant to heparin you
get the problem in animals, and then set up a standard that has
been incorporated around the world and we haven't seen those
kinds of reports that we were getting since that time.
Dr. Burgess. Well, now, heparin wouldn't truly be regarded
as a biologic but there has been some question in this
committee about how your agency would administer the follow-on
biologic approval process. So in light of everything, do you
feel like you have an adequate ability to safely and properly
monitor and implement the approval process for follow-on
biologics or what are referred to as follow-on biologics?
Dr. Sharfstein. From the perspective of the supply chain, I
think for all, you know, medications and biologics, we would
like to see strengthening of the supply chain including the
things that are there now but----
Dr. Burgess. Right. The supply chain in this instance just
showed the weakness, though, of the process used to identify
contaminants. In approving follow-up biologics, I mean, it
underscores how important the safety aspect is. Do you feel
that with what you have available to monitor and screen the
follow-on biologics in that process? We have had that debate
somewhat in this committee. We have never had you guys in to
ask you about that. We have had the Federal Trade Commission
in, which I never understood. So now that I have got you here,
what about the discussion on follow-on biologics?
Dr. Sharfstein. I think that the follow-on biologics sort
of supply chain issues are the same as for the regular. In some
cases, they are the same companies making them. So----
Dr. Burgess. No, outside the supply chain, just the overall
safety of follow-on biologics.
Dr. Sharfstein. That is something that is very important to
base on individual products and the best science available, and
FDA believes that with adequate resources and the right----
Dr. Burgess. You said you had all the money you needed,
remember, the previous question.
Dr. Sharfstein. I don't--we could check the transcript on
that one. I think that what we would like is the flexibility to
have standards that are based on the best available science for
particular products, and with that in place, we would explain
how we are setting up those standards and be able to do it in a
way that could get products on the market that could be
enormously important to the public.
Dr. Burgess. So where are we in that process now? We had
some language in the bill that we passed, and goodness knows
what is going to happen to that bill, but are you all waiting
for Congress to do something?
Dr. Sharfstein. I think we are certainly waiting to see
what happens with health care reform because there is some
language in there, but I think that we would also look to the
authority we have to decide whether it would make sense for us
to move forward without new language, but that is not something
we have reached final decision on.
Dr. Burgess. Is there a product out there right now that is
awaiting your ability to be able to offer those approvals or
direct further study?
Dr. Sharfstein. There is certainly a lot of interest in the
industry but I don't know if I could point to a particular
product.
Mr. Pallone. OK.
Dr. Burgess. Thank you, Mr. Chairman.
Mr. Pallone. You are welcome.
Let me thank Dr. Sharfstein. Thanks a lot. This was very
helpful, and we appreciate it, and obviously we would like to
move forward on the drug safety issue as we did on food safety.
You actually said that you are going to follow up with certain
written responses in some cases, so I would appreciate those as
soon as possible, and members can submit additional questions
for the record as well. I am going to try to get those
submitted to the clerk within the next 10 days, so I would ask
members if they want to submit written questions, to give them
to us within the next 10 days, and then after that we would ask
you to get back to us as quickly as possible.
Dr. Sharfstein. OK. Great.
Mr. Pallone. Thank you again, and without objection, the
hearing of the subcommittee is adjourned.
[Whereupon, at 4:22 p.m., the Subcommittee was adjourned.]
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