Drug Safety: Preliminary Findings Suggest Recent FDA Initiatives
Have Potential, but Do Not Fully Address Weaknesses in Its
Foreign Drug Inspection Program (22-APR-08, GAO-08-701T).
The Food and Drug Administration (FDA) is responsible for
overseeing the safety and effectiveness of human drugs that are
marketed in the United States, whether they are manufactured in
foreign or domestic establishments. FDA inspects foreign
establishments to ensure that they meet the same standards
required of domestic establishments. Ongoing concerns regarding
FDA's foreign drug inspection program recently were heightened
when FDA learned that contaminated doses of a common blood
thinner had been manufactured at a Chinese establishment that the
agency had never inspected. FDA has announced initiatives to
improve its foreign drug inspection program. In November 2007,
GAO testified on weaknesses in FDA's foreign drug inspection
program (GAO-08-224T). This statement presents preliminary
findings on how FDA's initiatives address the weaknesses GAO
identified. GAO interviewed FDA officials and analyzed FDA's
initiatives. GAO examined reports and proposals prepared by the
agency, as well as its plans to improve databases it uses to
manage its foreign drug inspection program.
-------------------------Indexing Terms-------------------------
REPORTNUM: GAO-08-701T
ACCNO: A81830
TITLE: Drug Safety: Preliminary Findings Suggest Recent FDA
Initiatives Have Potential, but Do Not Fully Address Weaknesses
in Its Foreign Drug Inspection Program
DATE: 04/22/2008
SUBJECT: Accountability
Data integrity
Databases
Drugs
Food and drug legislation
Foreign governments
Imported drugs
Importing
Inspection
International cooperation
International relations
Investigations by federal agencies
Pharmaceutical industry
Prescription drugs
Product safety
Program management
Risk assessment
program goals or objectives
Program implementation
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GAO-08-701T
* [1]Background
* [2]Recent Initiatives May Help FDA Select Foreign Establishment
* [3]FDA Initiatives Could Improve Its Data, but Will Not Ensure
* [4]FDA Initiatives to Obtain Information on Foreign Establishme
* [5]FDA Has Increased Its Inspections of Foreign Establishments,
* [6]FDA Initiatives May Address Some Challenges Unique to Foreig
* [7]Concluding Observations
* [8]Contacts and Acknowledgments
* [9]Order by Mail or Phone
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Testimony:
Before the Subcommittee on Oversight and Investigations, Committee on
Energy and Commerce, House of Representatives:
United States Government Accountability Office:
GAO:
For Release on Delivery:
Expected at 11:00 a.m. EDT:
Tuesday, April 22, 2008:
Drug Safety:
Preliminary Findings Suggest Recent FDA Initiatives Have Potential, but
Do Not Fully Address Weaknesses in Its Foreign Drug Inspection Program:
Statement of Marcia Crosse, Director:
GAO-08-701T:
GAO Highlights:
Highlights of GAO-08-701T, a testimony before the Subcommittee on
Oversight and Investigations, Committee on Energy and Commerce, House
of Representatives.
Why GAO Did This Study:
The Food and Drug Administration (FDA) is responsible for overseeing
the safety and effectiveness of human drugs that are marketed in the
United States, whether they are manufactured in foreign or domestic
establishments. FDA inspects foreign establishments to ensure that they
meet the same standards required of domestic establishments. Ongoing
concerns regarding FDA�s foreign drug inspection program recently were
heightened when FDA learned that contaminated doses of a common blood
thinner had been manufactured at a Chinese establishment that the
agency had never inspected. FDA has announced initiatives to improve
its foreign drug inspection program.
In November 2007, GAO testified on weaknesses in FDA�s foreign drug
inspection program (GAO-08-224T). This statement presents preliminary
findings on how FDA�s initiatives address the weaknesses GAO
identified. GAO interviewed FDA officials and analyzed FDA�s
initiatives. GAO examined reports and proposals prepared by the agency,
as well as its plans to improve databases it uses to manage its foreign
drug inspection program.
What GAO Found:
Recent FDA initiatives�some of which have been implemented and others
proposed�could strengthen FDA�s foreign drug inspection program, but
these initiatives do not fully address the weaknesses that GAO
previously identified.
* GAO testified in November 2007 that FDA�s databases do not provide an
accurate count of foreign establishments subject to inspection and do
provide widely divergent counts. Through one recent initiative, FDA has
taken steps to improve its database intended to include foreign
establishments registered to market drugs in the United States. This
initiative may reduce inaccuracies in FDA�s count of foreign
establishments. However, these steps will not prevent foreign
establishments that do not manufacture drugs for the U.S. market from
erroneously registering with FDA. Further, to reduce duplication in its
import database, FDA has supported a proposal that would change the
data it receives on products entering the United States. However, the
implementation of this proposal is not certain and would require action
from multiple federal agencies, in addition to FDA. Efforts to
integrate these databases have the potential to provide FDA with a more
accurate count of establishments subject to inspection, but it is too
early to tell.
* GAO testified that gaps in information weaken FDA�s processes for
prioritizing the inspection of foreign establishments that pose the
greatest risk to public health. While FDA recently expressed interest
in obtaining useful information from foreign regulatory bodies that
could help it prioritize foreign establishments for inspections, the
agency has faced difficulties fully utilizing these arrangements in the
past. For example, FDA had difficulties in determining whether the
scope of other countries� inspection reports met its needs and these
reports were not always readily available in English.
* GAO also testified that FDA inspected relatively few foreign
establishments each year. FDA made progress in inspecting more foreign
establishments in fiscal year 2007, but the agency still inspects far
fewer of them than domestic establishments. FDA dedicated about $10
million to foreign drug inspections in fiscal year 2007 and plans to
dedicate about $11 million to such inspections in fiscal year 2008.
* Finally, GAO testified that FDA faced certain logistical and staffing
challenges unique to conducting foreign inspections. FDA is pursuing
initiatives that could address some of the challenges that we
identified as being unique to foreign inspections, such as volunteer
inspection staff and lack of translators. FDA has proposed establishing
a dedicated cadre of staff to conduct foreign inspections, but the
timeframe associated with this initiative is unclear. FDA plans to open
an office in China and is considering establishing offices in other
countries, but the impact that this will have on the foreign drug
inspection program is unknown.
To view the full product, including the scope and methodology, click on
[hyperlink, http://www.gao.gov/cgi-bin/getrpt?GAO-08-701T]. For more
information, contact Marcia Crosse at (202) 512-7114 or
[email protected].
[End of section]
Mr. Chairman and Members of the Subcommittee:
I am pleased to be here today as you consider the Food and Drug
Administration's (FDA) plans to improve its program for inspecting
foreign drug manufacturers whose products are marketed in the United
States. America has become increasingly dependent on drugs and drug
ingredients manufactured in foreign countries. Ten years ago, we
reported that FDA needed to improve its foreign drug inspection
program.[Footnote 1] Among other things, we noted that FDA had serious
problems managing its foreign inspection data. We were also critical of
the number of inspections FDA conducted at foreign manufacturers. In
November 2007, we testified on the preliminary findings of our current
work in which we identified weaknesses similar to those we found in our
previous report.[Footnote 2] Our preliminary findings suggested that
FDA had weaknesses in its databases, including conflicting information
on the number of foreign establishments subject to inspection;[Footnote
3] had information gaps that weakened its process for selecting foreign
establishments for inspection; conducted infrequent inspections of
these establishments; and faced logistical and staffing challenges
unique to foreign inspections. Recent developments involving heparin
sodium, a commonly used blood thinner, have further heightened concerns
about the safety of drugs and drug ingredients and FDA's ability to
inspect foreign manufacturers of these products. In January 2008, FDA
began an investigation after receiving reports of serious adverse
events in people receiving this drug. The agency later learned that an
active pharmaceutical ingredient (API) found in heparin sodium
contained a contaminant and had been manufactured at a Chinese
establishment never inspected by FDA.[Footnote 4]
Recently, FDA has begun or proposed initiatives to strengthen its
foreign drug inspection program.[Footnote 5] You asked us to assess
whether FDA's initiatives will improve its management of this program.
My testimony today will focus on these initiatives and how they address
the weaknesses we previously identified.
To obtain information about FDA initiatives and how they address
weaknesses in its program for inspecting foreign drug manufacturers, we
interviewed officials from FDA, including from its Center for Drug
Evaluation and Research (CDER) and Office of Regulatory Affairs (ORA),
which each have responsibilities for managing the foreign inspection
program. We examined reports and proposals prepared by the agency on
related initiatives. We also examined FDA's plans to improve databases
it uses to manage its foreign drug inspection program, including its
Field Accomplishments and Compliance Tracking System (FACTS),
Operational and Administrative System for Import Support (OASIS), and
Drug Registration and Listing System (DRLS).[Footnote 6] Our November
2007 testimony included the number of inspections from FACTS as of
September 26, 2007. To provide information to update those preliminary
findings, we obtained FACTS data that contained information on fiscal
year 2007 inspections conducted or entered into this database since our
previous analysis. We also obtained fiscal year 2007 data from OASIS to
determine the types of drug products manufactured in China and offered
for entry into the United States. We assessed the reliability of these
databases by (1) reviewing existing information about the data and the
databases that produced them, (2) interviewing agency officials
knowledgeable about the data, and (3) performing electronic testing of
required data elements. We found the data in the FACTS database
reliable for our purposes. In addition, we found that while OASIS is
likely to over-estimate the number of foreign establishments involved
in the manufacture of those drugs because of uncorrected errors in the
data, it provides sufficiently reliable information about the types of
drugs offered for entry into the United States. The information we
present represents the best information available and is what FDA
relies on to manage its foreign drug inspection activities. Our ongoing
work is focused on human drugs regulated by CDER and not on biologics,
[Footnote 7] medical devices, veterinary medicines, food, or other
items or products for which FDA conducts inspections. However, we
obtained information from the center responsible for medical devices,
the Center for Devices and Radiological Health (CDRH), to learn about a
recent change to one of its databases that addresses problems similar
to those in DRLS. We shared the facts contained in this statement with
FDA officials. They provided technical comments, which we incorporated
as appropriate. We conducted the work for our November 2007 testimony
from September 2007 through October 2007, and we conducted our work for
this statement from March 2008 through April 2008. All of our work is
being performed in accordance with generally accepted government
auditing standards. Those standards require that we plan and perform
the audit to obtain sufficient, appropriate evidence to provide a
reasonable basis for our findings and conclusions based on our audit
objectives. We believe that the evidence obtained provides a reasonable
basis for our findings and conclusions based on our audit objectives.
In summary, recent FDA initiatives--some of which have been implemented
and others proposed--could strengthen FDA's foreign drug inspection
program, but these initiatives do not fully address the weaknesses that
we previously identified. For example, we found that FDA's databases do
not provide an accurate count of foreign establishments subject to
inspection. FDA plans to implement electronic registration for foreign
establishments. Implementing such a process may reduce inaccuracies in
FDA's database of registered establishments. However, this will not
prevent foreign establishments that do not manufacture drugs for the
U.S. market from erroneously registering with FDA. For example, in some
foreign markets, foreign drug manufacturers may register with FDA
because registration may appear to convey an "approval" or endorsement
by the agency. To reduce duplication in FDA's import database, FDA
supported a proposal to create a unique governmentwide identifier for
all establishments whose products are imported into the United States.
However, the implementation of this identifier is not certain and would
require action from multiple federal agencies in addition to FDA.
Efforts to integrate these databases have the potential to provide FDA
with a more accurate count of establishments subject to inspection, but
it is too early to tell. FDA has also taken steps that could help it
select foreign establishments for inspection by obtaining information
from foreign regulatory bodies. However, the agency has not fully
utilized arrangements with foreign regulatory bodies in the past that
would allow it to obtain such information. FDA has also made progress
in conducting more foreign inspections, but it still inspects
relatively few establishments. FDA is pursuing initiatives that could
address some of the challenges that we identified as unique to foreign
inspections. For example, the agency has proposed establishing overseas
offices, beginning in China, but the impact that these offices will
have on the foreign drug inspection program is unknown. To date, it is
unclear whether the agency's proposals will increase the frequency with
which FDA inspects foreign establishments or the quality of information
it uses to select establishments to inspect.
Background:
FDA is responsible for overseeing the safety and effectiveness of human
drugs that are marketed in the United States, whether they are
manufactured in foreign or domestic establishments.[Footnote 8] Foreign
establishments that market their drugs in the United States must
register with FDA. As part of its efforts to ensure the safety and
quality of imported drugs, FDA may inspect foreign establishments whose
products are imported into the United States. Regular inspections of
manufacturing establishments are an essential component of ensuring
drug safety. Conducting testing of finished dosage form drug products
cannot reliably determine drug quality. Therefore, FDA relies on
inspections to determine an establishment's compliance with current
good manufacturing practice regulations (GMP).[Footnote 9] These
inspections are a critical mechanism in FDA's process of assuring that
the safety and quality of drugs are not jeopardized by poor
manufacturing practices.
Requirements governing foreign and domestic inspections differ.
Specifically, FDA is required to inspect every 2 years those domestic
establishments that manufacture drugs marketed in the United
States,[Footnote 10] but there is no comparable requirement for
inspecting foreign establishments. FDA does not have authority to
require foreign establishments to allow the agency to inspect their
facilities. However, FDA has the authority to conduct physical
examinations of products offered for import, and if there is sufficient
evidence of a violation, prevent their entry at the border.
Within FDA, CDER sets standards and evaluates the safety and
effectiveness of prescription and over-the-counter drugs. Among other
things, CDER requests that ORA inspect both foreign and domestic
establishments to ensure that drugs are produced in conformance with
federal statutes and regulations, including current GMPs. CDER requests
that ORA conduct inspections of establishments that produce drugs in
finished-dosage form as well as those that produce bulk drug
substances,[Footnote 11] including APIs used in finished drug products.
These inspections are performed by investigators and, on occasion,
laboratory analysts.[Footnote 12] ORA conducts two primary types of
drug manufacturing establishment inspections:
* Preapproval inspections of domestic and foreign establishments are
conducted before FDA will approve a new drug to be marketed in the
United States.[Footnote 13] These inspections occur following FDA's
receipt of a new drug application (NDA) or an abbreviated new drug
application (ANDA) and focus on the manufacture of a specific
drug.[Footnote 14] Preapproval inspections are designed to verify the
accuracy and authenticity of the data contained in these applications
to determine that the manufacturer is following commitments made in the
application. FDA also determines that the manufacturer of the finished
drug product, as well as each manufacturer of a bulk drug substance
used in the finished product, manufactures, processes, packs, and
labels the drug adequately to preserve its identity, strength, quality,
and purity.
* Postapproval GMP surveillance inspections are conducted to ensure
ongoing compliance with the laws and regulations pertaining to the
manufacturing processes used by domestic and foreign establishments in
the manufacture of drug products marketed in the United States and bulk
drug substances used in the manufacture of those products. These
inspections focus on a manufacturer's systemwide controls for ensuring
that drug products are of high quality. Systems examined during these
inspections include those related to materials, quality control,
production, facilities and equipment, packaging and labeling, and
laboratory controls. These systems may be involved in the manufacture
of multiple drug products.[Footnote 15]
FDA has established arrangements with regulatory bodies in other
countries to facilitate the sharing of information about drug
inspections. FDA has entered into arrangements related to GMP
inspections with Canada, Japan, the European Union, and others. The
scope of such arrangements can vary. Some arrangements may allow FDA to
obtain reports of inspections conducted by other countries, for
informational purposes. Other arrangements may involve more than the
exchange of information. For example, FDA and another country may enter
into an arrangement to work towards the mutual recognition of each
other's inspection standards or the acceptance of one another's
inspections, in lieu of their own.
CDER uses a risk-based process to select some foreign and domestic
establishments for postapproval GMP surveillance inspections. The
process uses a risk-based model to identify those establishments that,
based on characteristics of the establishment and of the product being
manufactured, have the greatest public health risk potential should
they experience a manufacturing defect. For example, FDA considers the
risk to public health from poor quality over-the-counter drugs to be
lower than for prescription drugs. Consequently establishments
manufacturing only over-the-counter drugs receive a lower score on this
factor in the risk-based process than other manufacturers. Through this
process, CDER annually prepares a prioritized list of domestic
establishments and a separate, prioritized list of foreign
establishments.
FDA uses multiple databases to manage its foreign drug inspection
program.
* DRLS contains information on foreign and domestic drug establishments
that have registered with FDA to market their drugs in the United
States. These establishments must also list any drugs they market in
the United States. These establishments provide information, such as
company name and address and the drug products they manufacture for
commercial distribution in the United States, on paper forms, which are
entered into DRLS by FDA staff.
* OASIS contains information on drugs and other FDA-regulated products
offered for entry into the United States, including information on the
establishment that manufactured the drug. The information in OASIS is
automatically generated from data managed by Customs and Border
Protection (CBP). The data are originally entered by customs brokers
based on the information available from the importer.[Footnote 16] CBP
specifies an algorithm by which customs brokers generate a manufacturer
identification number from information about an establishment's name,
address, and location.
* FACTS contains information on FDA's inspections of foreign and
domestic drug establishments. FDA investigators and laboratory analysts
enter information into FACTS following completion of an inspection.
According to DRLS, in fiscal year 2007, foreign countries that had the
largest number of registered establishments were Canada, China, France,
Germany, India, Italy, Japan, and the United Kingdom. These countries
are also listed in OASIS as having the largest number of manufacturers
offering drugs for entry into the United States. Specifically,
according to OASIS, China had more establishments manufacturing drugs
that were offered for entry into the United States than any other
country. According to OASIS, in fiscal year 2007, a wide variety of
prescription and over-the-counter drug products manufactured in China
were offered for entry into the United States, including pain killers,
antibiotics, blood thinners, and hormones.
In November 2007, we testified on preliminary findings that identified
weaknesses in FDA's program for inspecting foreign establishments
manufacturing drugs for the U.S. market. Specifically, we found that,
as in 1998, FDA's effectiveness in managing the foreign drug inspection
program continued to be hindered by weaknesses in its data on foreign
establishments. FDA did not know how many foreign establishments were
subject to inspection. FDA relied on databases that were designed for
purposes other than managing the foreign drug inspection program.
Further, these databases contained inaccuracies that FDA could not
easily reconcile. DRLS indicated there were about 3,000 foreign
establishments registered with FDA in fiscal year 2007,[Footnote 17]
while OASIS indicated that about 6,800 foreign establishments actually
offered drugs for entry in that year. FDA recognized these
inconsistencies, but could not easily correct them partly because the
databases could not exchange information. Any comparisons of the data
must be performed manually, on a case-by-case basis.
We also testified that FDA inspected relatively few foreign
establishments.[Footnote 18] Data from FDA suggested that the agency
may inspect about 8 percent of foreign establishments in a given year.
At this rate, it would take FDA more than 13 years to inspect each
foreign establishment once, assuming that no additional establishments
require inspection. However, FDA could not provide an exact number of
foreign establishments that had never been inspected. From fiscal year
2002 through fiscal year 2007, FDA conducted 1,479 inspections of
foreign establishments, and three quarters of these inspections were
concentrated in 10 countries. (See table 1.) Because some
establishments were inspected more than once during this time period,
FDA actually inspected 1,119 unique establishments. For example, of the
94 inspections that FDA conducted of Chinese establishments, it
inspected 80 unique establishments across this six year period. The
lowest rate of inspections in these 10 countries was in China, for
which FDA inspected 80 of its estimated 714 establishments, or fewer
than 14 establishments per year, on average.
Table 1: Number of FDA Inspections of Foreign Establishments Involved
in the Manufacture of Drugs for the U.S. Market, by Country for the 10
Most Frequently Inspected Countries, Fiscal Year 2002 through Fiscal
Year 2007:
Country: India;
Number of inspections: FY2002: 11;
Number of inspections: FY2003: 19;
Number of inspections: FY2004: 38;
Number of inspections: FY2005: 33;
Number of inspections: FY2006: 34;
Number of inspections: FY2007: 64;
Number of inspections: Total: 199;
Number of unique establishments inspected: 152;
Number of establishments[A]: 410.
Country: Germany;
Number of inspections: FY2002: 24;
Number of inspections: FY2003: 15;
Number of inspections: FY2004: 35;
Number of inspections: FY2005: 25;
Number of inspections: FY2006: 19;
Number of inspections: FY2007: 25;
Number of inspections: Total: 143;
Number of unique establishments inspected: 95;
Number of establishments[A]: 199.
Country: Italy;
Number of inspections: FY2002: 17;
Number of inspections: FY2003: 30;
Number of inspections: FY2004: 26;
Number of inspections: FY2005: 21;
Number of inspections: FY2006: 18;
Number of inspections: FY2007: 28;
Number of inspections: Total: 140;
Number of unique establishments inspected: 98;
Number of establishments[A]: 150.
Country: Canada;
Number of inspections: FY2002: 29;
Number of inspections: FY2003: 12;
Number of inspections: FY2004: 17;
Number of inspections: FY2005: 23;
Number of inspections: FY2006: 23;
Number of inspections: FY2007: 20;
Number of inspections: Total: 124;
Number of unique establishments inspected: 88;
Number of establishments[A]: 288.
Country: United Kingdom;
Number of inspections: FY2002: 17;
Number of inspections: FY2003: 21;
Number of inspections: FY2004: 15;
Number of inspections: FY2005: 18;
Number of inspections: FY2006: 15;
Number of inspections: FY2007: 16;
Number of inspections: Total: 102;
Number of unique establishments inspected: 84;
Number of establishments[A]: 169.
Country: China;
Number of inspections: FY2002: 11;
Number of inspections: FY2003: 9;
Number of inspections: FY2004: 17;
Number of inspections: FY2005: 21;
Number of inspections: FY2006: 17;
Number of inspections: FY2007: 19;
Number of inspections: Total: 94;
Number of unique establishments inspected: 80;
Number of establishments[A]: 714.
Country: France;
Number of inspections: FY2002: 14;
Number of inspections: FY2003: 15;
Number of inspections: FY2004: 13;
Number of inspections: FY2005: 12;
Number of inspections: FY2006: 16;
Number of inspections: FY2007: 24;
Number of inspections: Total: 94;
Number of unique establishments inspected: 71;
Number of establishments[A]: 162.
Country: Japan;
Number of inspections: FY2002: 11;
Number of inspections: FY2003: 13;
Number of inspections: FY2004: 14;
Number of inspections: FY2005: 21;
Number of inspections: FY2006: 13;
Number of inspections: FY2007: 22;
Number of inspections: Total: 94;
Number of unique establishments inspected: 82;
Number of establishments[A]: 196.
Country: Switzerland;
Number of inspections: FY2002: 12;
Number of inspections: FY2003: 12;
Number of inspections: FY2004: 11;
Number of inspections: FY2005: 17;
Number of inspections: FY2006: 9;
Number of inspections: FY2007: 17;
Number of inspections: Total: 78;
Number of unique establishments inspected: 50;
Number of establishments[A]: 83.
Country: Ireland;
Number of inspections: FY2002: 11;
Number of inspections: FY2003: 5;
Number of inspections: FY2004: 11;
Number of inspections: FY2005: 14;
Number of inspections: FY2006: 3;
Number of inspections: FY2007: 14;
Number of inspections: Total: 58;
Number of unique establishments inspected: 43;
Number of establishments[A]: 61.
Country: All other countries;
Number of inspections: FY2002: 63;
Number of inspections: FY2003: 38;
Number of inspections: FY2004: 63;
Number of inspections: FY2005: 61;
Number of inspections: FY2006: 45;
Number of inspections: FY2007: 83;
Number of inspections: Total: 353;
Number of unique establishments inspected: 276;
Number of establishments[A]: 817.
Country: Total;
Number of inspections: FY2002: 220;
Number of inspections: FY2003: 189;
Number of inspections: FY2004: 260;
Number of inspections: FY2005: 266;
Number of inspections: FY2006: 212;
Number of inspections: FY2007: 332;
Number of inspections: Total: 1,479;
Number of unique establishments inspected: 1,119;
Number of establishments[A]: 3,249.
Source: GAO analysis of FDA data.
[A] This count represents the number of establishments FDA used to plan
its fiscal year 2007 prioritized surveillance inspections. In preparing
this list, FDA draws on information from DRLS. It also obtains
information from previous inspections to help it identify
establishments that are subject to inspection but are not required to
register--such as the manufacturer of an API whose product is not
directly imported into the United States. However, as a result of the
inaccuracies in DRLS, FDA recognizes that this list does not provide an
accurate count of establishments subject to inspection.
[End of table]
We testified that, while enforcing GMP compliance through surveillance
inspections was FDA's most comprehensive program for monitoring the
quality of marketed drugs, most of FDA's inspections of foreign
manufacturers occurred when they were listed in an NDA or ANDA. The
majority of these preapproval inspections were combined with a GMP
surveillance inspection. Although FDA used a risk-based process to
develop a prioritized list of foreign establishments for GMP
surveillance inspections, few were completed in a given year--about 30
in fiscal year 2007. The usefulness of the process was weakened by the
incomplete and possibly inaccurate information on those foreign
establishments that FDA had not inspected recently, as well as those
that had never been the subject of a GMP surveillance inspection.
We also testified that FDA's foreign inspection process involves unique
circumstances that are not encountered domestically. For example, FDA
relies on staff that inspect domestic establishments to volunteer for
foreign inspections. Unlike domestic inspections, FDA does not arrive
unannounced at a foreign establishment. It also lacks the flexibility
to easily extend foreign inspections if problems are encountered.
Finally, language barriers can make foreign inspections more difficult
than domestic ones. FDA does not generally provide translators to its
inspection teams. Instead, they may have to rely on an English-speaking
representative of the foreign establishment being inspected, rather
than an independent translator.
Recent Initiatives May Help FDA Select Foreign Establishments for
Inspection, but Weaknesses in Its Foreign Drug Inspection Program Are
Not Fully Addressed:
FDA has initiated several recent changes to its foreign drug inspection
program, but the changes do not fully address the weaknesses that we
previously identified. FDA has initiatives underway to reduce the
inaccuracies in its registration and import databases that make it
difficult to determine the number of foreign establishments subject to
inspection, although to date these databases still do not provide an
accurate count of such establishments. FDA has taken steps that could
help it select foreign establishments for inspection by obtaining
information from foreign regulatory bodies. However, the agency has not
fully utilized arrangements with foreign regulatory bodies in the past
that would allow it to obtain such information. FDA has made progress
in conducting more foreign inspections, but it still inspects
relatively few establishments. FDA is also pursuing initiatives that
could address some of the challenges that we identified as being unique
to foreign inspections, but implementation details and timeframes
associated with these initiatives are unclear.
FDA Initiatives Could Improve Its Data, but Will Not Ensure an Accurate
Count of Foreign Establishments Subject to Inspection:
FDA has initiatives underway to reduce inaccuracies in its databases,
but actions taken thus far will not ensure that the agency has an
accurate count of establishments subject to inspection. As we
previously testified, DRLS does not provide FDA with an accurate count
of foreign establishments manufacturing drugs for the U.S. market. For
example, foreign establishments may register with FDA, whether or not
they actually manufacture drugs for the U.S. market,[Footnote 19] and
the agency does not routinely verify the information provided by the
establishment. Beginning in late 2008, CDER plans to implement an
electronic registration and listing system that could improve the
accuracy of information the agency maintains on registered
establishments. The new system will allow drug manufacturing
establishments to submit registration and listing information
electronically, rather than submitting it on paper forms. FDA hopes
that electronic registration will result in efficiencies allowing the
agency to shift resources from data entry to assuring the quality of
the databases. However, electronic registration alone will not prevent
foreign establishments that do not manufacture drugs for the U.S.
market from registering, thus still presenting the problem of an
inaccurate count.
Recently, another FDA center implemented changes affecting the
registration of medical device manufacturers, an activity for which we
previously identified problems similar to those found in CDER.[Footnote
20] In fiscal year 2008, CDRH implemented, in addition to electronic
registration, an annual user fee of $1,706 per registration for certain
medical device establishments[Footnote 21] and an active re-
registration process.[Footnote 22] According to CDRH, as of early April
2008, about half of the previously registered establishments have
reregistered using the new system. While CDRH officials expect that
this number will increase,[Footnote 23] they expect that the
elimination of establishments that do not manufacture medical devices
for the U.S. market--and thus should not be registered--will result in
a smaller, more accurate database of medical device establishments.
CDRH officials indicated that implementation of electronic registration
and the annual user fee seems to have improved the data so CDRH can
more accurately identify the type of establishment registered, the
devices manufactured at an establishment, and whether or not an
establishment should be registered. According to CDRH officials, the
revenue from device registration user fees is applied to the process
for the review of device applications,[Footnote 24] including
establishment inspections undertaken as part of the application review
process. CDER does not currently have the authority to assess a user
fee for registration of drug establishments, but officials indicated
that such a fee could discourage registrations of foreign manufacturers
that are not ready, are not actively importing, or have not been
approved to market drug products in the United States. Officials also
suggested that such fees could be used to supplement the resources
available for conducting inspections.
FDA has proposed, but not yet implemented, the Foreign Vendor
Registration Verification Program, which could help improve the
accuracy of information FDA maintains on registered establishments.
Through this program, FDA plans to contract with an external
organization to conduct on-site verification of the registration data
and product listing information of foreign establishments shipping
drugs and other FDA-regulated products to the United States. As of
April 2008, FDA had solicited proposals for this contract but was still
developing the specifics of the program. For example, the agency had
not yet established the criteria it would use to determine which
establishments would be visited for verification purposes or determined
how many establishments it would verify annually. FDA currently plans
to award this contract in May 2008. Given the early stages of this
process, it is too soon to determine whether this program will improve
the accuracy of the data FDA maintains on foreign drug establishments.
In addition to changes to improve DRLS, FDA has supported a proposal
that has the potential to address weaknesses in OASIS, but FDA does not
control the implementation of this change. As we previously testified,
OASIS contains an inaccurate count of foreign establishments
manufacturing drugs imported to the United States as a result of
unreliable identification numbers generated by customs brokers when the
product is offered for entry.[Footnote 25] FDA officials told us that
these errors result in the creation of multiple records for a single
establishment, which results in inflated counts of establishments
offering drugs for entry into the U.S. market. FDA is pursuing the
creation of a governmentwide unique establishment identifier, as part
of the Shared Establishment Data Service (SEDS), to address these
inaccuracies.[Footnote 26] Rather than relying on the creation and
entry of an identifier at the time of import, SEDS would provide a
unique establishment identifier and a centralized service to provide
commercially verified information about establishments. The standard
identifier would be submitted as part of import entry data where
required by FDA or other government agencies. SEDS could thus eliminate
the problem of having multiple identifiers associated with an
individual establishment. The implementation of SEDS is dependent on
action from multiple federal agencies, including the integration of the
concept into a CBP import and export system currently under development
and scheduled for implementation in 2010. In addition, once implemented
by CBP, participating federal agencies would be responsible for bearing
the cost of integrating SEDS with their own operations and systems. FDA
officials are not aware of a specific timeline for the implementation
of SEDS. Developing an implementation plan for SEDS is a recommendation
of the Interagency Working Group on Import Safety's Action Plan for
Import Safety: A Roadmap for Continual Improvement.
Finally, FDA is in the process of implementing additional initiatives
to improve the integration of its current data systems, which could
make it easier for the agency to establish an accurate count of foreign
drug manufacturing establishments subject to inspection. The agency's
Mission Accomplishments and Regulatory Compliance Services (MARCS) is
intended to help FDA electronically integrate data from multiple
systems. It is specifically designed to give individual users a more
complete picture of establishments. FDA officials estimate that MARCS,
which is being implemented in stages, could be fully implemented by
2011 or 2012. However, FDA officials told us that implementation has
been slow because the agency has been forced to shift resources away
from MARCS and toward the maintenance of current systems that are still
heavily used, such as FACTS and OASIS. Taken together, electronic
registration, the Foreign Vendor Registration Verification Program,
SEDS, and MARCS could provide the agency with more accurate information
on the number of establishments subject to inspection. However, it is
too early to tell.
FDA Initiatives to Obtain Information on Foreign Establishments May
Have Limited Impact on Its Selection of Establishments to Inspect:
FDA has taken steps to help it select establishments for inspection by
obtaining information on foreign establishments from regulatory bodies
in other countries, despite encountering difficulties in fully
utilizing these arrangements in the past. FDA has recognized the
importance of receiving information about foreign establishments from
other countries and has taken steps to develop new, or strengthen
existing, information-sharing arrangements to do so. For example,
according to FDA, the agency is enhancing an arrangement to exchange
information with the Swiss drug regulatory agency. FDA officials have
highlighted such arrangements as a means of improving the agency's
oversight of drugs manufactured in foreign countries. For example, they
told us that in selecting establishments for GMP surveillance
inspections, they sometimes use the results of an establishment
inspection conducted by a foreign government to determine whether to
inspect an establishment.[Footnote 27] FDA told us that it received
drug inspection information from foreign regulatory bodies six times in
2007.
FDA has previously encountered difficulties which prevented it from
taking full advantage of information-sharing arrangements with other
countries. Obtaining inspection reports from other countries and using
this information has proved challenging. In order for FDA to determine
the value of inspection reports from a particular country, it must
consider whether the scope of that country's inspections is sufficient
for FDA's needs. Evaluation of inspections conducted by foreign
regulatory bodies can be complex and may include on-site review of
regulatory systems and audit inspections. Further, to obtain results of
inspections conducted by its foreign counterparts, FDA must
specifically request them--they are not automatically provided. While
FDA has provided certain foreign regulatory bodies access to its
Compliance Status Information System--which provides information from
the results of FDA's inspections--foreign regulatory bodies have not
established similar systems to provide FDA access to data about their
inspections. FDA indicated that such systems are under development in
some countries and FDA has been promised access when they are
available. However, currently, FDA cannot routinely incorporate the
results of inspections conducted by foreign regulatory authorities into
its risk-based selection process.[Footnote 28] FDA officials stated
that, in the past, they encountered difficulties using inspection
reports from other countries that were not readily available in
English. Consequently, the existence of such information-sharing
arrangements alone may not help FDA systematically address identified
weaknesses in its foreign inspection program.
Arrangements that have the potential to allow FDA to formally accept
the results of inspections conducted by other countries have been
prohibitively challenging to implement. Although these arrangements
allow countries to leverage their own inspection resources, according
to FDA officials, assessing the equivalence of other countries'
inspections and the relevance of the information available is
difficult. They added that complete reliance on another country's
inspection results is risky. The activities associated with
establishing these agreements may be resource intensive, which may slow
FDA's implementation of them. For example, FDA told us that a lack of
funding for establishing such an arrangement with the European Union
effectively stopped progress. Although FDA has completed preliminary
work associated with this arrangement, the agency has concluded that it
will be more beneficial to pursue other methods of cooperating with the
European Union. The agency has no plans at this time to enter into
other such arrangements.
FDA's current efforts to obtain more information from foreign
regulatory bodies may help it better assess the risk of foreign
establishments when prioritizing establishments for GMP surveillance
inspections. However, most foreign inspections are conducted to examine
an establishment referenced in an NDA or ANDA. The agency conducts
relatively few foreign GMP surveillance inspections selected through
its risk-based process. Therefore, these efforts may be of limited
value to the foreign inspection program if the agency does not increase
the number of such inspections.
FDA Has Increased Its Inspections of Foreign Establishments, but Still
Inspects Relatively Few:
FDA has made progress in conducting more foreign inspections, but it
still inspects relatively few establishments. FDA conducted more
foreign establishment inspections in fiscal year 2007 than it had in
each of the 5 previous fiscal years. However, the agency still
inspected less than 11 percent of the foreign establishments on the
prioritized list that it used to plan its fiscal year 2007 GMP
surveillance inspections.[Footnote 29] The agency also still conducts
far fewer inspections of foreign establishments than domestic
establishments. Its budget calls for incremental increases in funding
for foreign inspections. FDA officials told us that, for fiscal year
2008, the agency plans to conduct more GMP surveillance inspections
based on its prioritized list of foreign establishments. FDA officials
estimated that the agency conducted about 30 such inspections in fiscal
year 2007 and plans to conduct at least 50 in fiscal year 2008.
If FDA were to inspect foreign establishments biennially, as is
required for domestic establishments, this would require FDA to
dedicate substantially more funding than it has dedicated to such
inspections in the past. In fiscal year 2007, FDA dedicated about $10
million to inspections of foreign establishments.[Footnote 30] FDA
estimates that, based on the time spent conducting inspections of
foreign drug manufacturing establishments in fiscal year 2007, the
average cost of such an inspection ranges from approximately $41,000 to
$44,000.[Footnote 31] Our analysis suggests that it could cost the
agency $67 million to $71 million each year to biennially inspect each
of the 3,249 foreign drug establishments on the list that FDA used to
plan its fiscal year 2007 GMP surveillance inspections. Based on these
same estimates, it would take the agency $15 million to $16 million
each year to inspect the estimated 714 drug manufacturing
establishments in China every 2 years. According to FDA budget
documents, the agency estimates that it will dedicate a total of about
$11 million in fiscal year 2008 and $13 million in fiscal year 2009 to
all foreign inspections.
In its fiscal year 2009 budget, FDA proposed instituting a reinspection
user fee.[Footnote 32] Reinspections are conducted to verify that
corrective actions the agency has required establishments to take in
response to previously identified violations have been implemented.
FDA's proposal to institute a reinspection user fee would allow it to
charge establishments a fee when the agency determines a reinspection
is warranted. However, as proposed, the reinspection user fee would be
budget neutral, meaning that the other appropriated funds the agency
receives would be offset by the amount of collected reinspection fees.
As a result, this proposal would not provide the agency with an
increase in funds that could be used to pay for additional foreign
inspections.
FDA Initiatives May Address Some Challenges Unique to Foreign
Inspections, but It Is Too Early to Determine Their Effectiveness:
FDA has recently announced proposals to address some of the challenges
unique to conducting foreign inspections, but specific implementation
steps and associated time frames are unclear. We previously identified
the lack of a dedicated staff devoted to conducting foreign inspections
as a challenge for the agency. FDA noted in its report on the
revitalization of ORA that it is exploring the creation of a cadre of
investigators who would be dedicated to conducting foreign
inspections.[Footnote 33] However, the report does not provide any
additional details or timeframes about this proposal. In addition, FDA
recently announced plans to establish a permanent foreign presence
overseas, although little information about these plans is available.
Through an initiative known as "Beyond our Borders," FDA intends that
its foreign offices will improve cooperation and information exchange
with foreign regulatory bodies, improve procedures for expanded
inspections, allow it to inspect facilities quickly in an emergency,
and facilitate work with private and government agencies to assure
standards for quality. FDA's proposed foreign offices are intended to
expand the agency's capacity for regulating, among other things, drugs,
medical devices, and food. The extent to which the activities conducted
by foreign offices are relevant to FDA's foreign drug inspection
program is uncertain. Initially, FDA plans to establish a foreign
office in China with three locations--Beijing, Shanghai, and Guangzhou-
-comprised of a total of eight FDA employees and five Chinese
nationals. The Beijing office, which the agency expects will be
partially staffed by the end of 2008, will be responsible for
coordination between FDA and the Chinese regulatory agencies. FDA staff
located in Shanghai and Guangzhou, who will be hired in 2009, will be
focused on conducting inspections and working with Chinese inspectors
to provide training as necessary. FDA has noted that the Chinese
nationals will primarily provide support to FDA staff including
translation and interpretation. The agency is also considering setting
up offices in other locations, such as India, the Middle East, Latin
America, and Europe, but no dates have been specified. While the
establishment of both a foreign inspection cadre and offices overseas
have the potential for improving FDA's oversight of foreign
establishments and providing the agency with better data on foreign
establishments, it is too early to tell whether these steps will be
effective or will increase the number of foreign drug inspections.
Agreements with foreign governments, such as one recently reached with
China's State Food and Drug Administration, may help the agency address
certain logistical issues unique to conducting inspections of foreign
establishments. We previously testified that one challenge faced by FDA
involved the need for its staff to obtain a visa or letter of
invitation to enter a foreign country to conduct an inspection.
However, FDA officials told us that their agreement with China recently
helped FDA expedite this process when it learned of the adverse events
associated with a Chinese heparin manufacturer. According to these
officials, the agreement with China greatly facilitated its inspection
of this manufacturer by helping FDA send investigators much more
quickly than was previously possible.
Concluding Observations:
Americans depend on FDA to ensure the safety and effectiveness of the
drugs they take. The recent incident involving heparin underscores the
importance of FDA's initiatives and its steps to obtain more
information about foreign drug establishments, conduct more inspections
overseas, and improve its overall management of its foreign drug
inspection program. FDA has identified actions that, if fully
implemented, could address some, but not all, of the concerns we first
identified 10 years ago and reiterated 5 months ago in our testimony
before this subcommittee. Given the growth in foreign drug
manufacturing for the U.S. market and the current large gaps in FDA's
foreign drug inspections, FDA will need to devote considerable
resources to this area if it is to increase the rate of inspections.
However, FDA's plans currently call for incremental increases that will
have little impact in the near future to reduce the interval between
inspections for these establishments. In addition, many of FDA's
initiatives will take several years to implement and require funding
and certain interagency or intergovernmental agreements that are not
yet in place. Taken together, FDA's plans represent a step forward in
filling the large gaps in FDA's foreign drug inspection program, but do
little to accomplish short-term change.
Mr. Chairman, this completes my prepared statement. I would be happy to
respond to any questions you or the other Members of the subcommittee
may have at this time.
Contacts and Acknowledgments:
For further information about this testimony, please contact Marcia
Crosse at (202) 512-7114 or [email protected]. Contact points for our
Offices of Congressional Relations and Public Affairs may be found on
the last page of this testimony. Geraldine Redican-Bigott, Assistant
Director; Katherine Clark; William Hadley; Cathleen Hamann; Julian
Klazkin; Lisa Motley; Daniel Ries; and Monique B. Williams made key
contributions to this testimony.
[End of testimony]
Footnotes:
[1] GAO, Food and Drug Administration: Improvements Needed in the
Foreign Drug Inspection Program, [hyperlink, http://www.gao.gov/cgi-
bin/getrpt?GAO/HEHS-98-21] (Washington, D.C.: Mar. 17, 1998).
[2] GAO, Drug Safety: Preliminary Findings Suggest Weaknesses in FDA's
Program for Inspecting Foreign Drug Manufacturers, [hyperlink,
http://www.gao.gov/cgi-bin/getrpt?GAO-08-224T] (Washington, D.C.: Nov.
1, 2007). We also recently testified about similar weaknesses that we
identified in FDA's program for inspecting foreign medical device
manufacturers. GAO, Medical Devices: Challenges for FDA in Conducting
Manufacturer Inspections, [hyperlink, http://www.gao.gov/cgi-
bin/getrpt?GAO-08-428T] (Washington, D.C.: Jan. 29, 2008).
[3] FDA regulations define an establishment as a place of business
under one management at one general physical location. 21 C.F.R. �
207.3(a)(7) (2007). Drug firms may have more than one establishment.
[4] An API is any component that is intended to provide pharmacological
activity or other direct effect in the diagnosis, cure, mitigation,
treatment, or prevention of disease. FDA defines inactive ingredients
as any component of a drug product other than the API, such as
materials that improve the appearance, stability, and palatability of
the product. According to FDA officials, the agency typically only
inspects establishments manufacturing inactive ingredients on a for-
cause basis.
[5] See, for example, Food and Drug Administration, Revitalizing ORA:
Protecting the Public Health Together In a Changing World (Rockville,
Md.: Jan. 2008).
[6] We also previously examined the reliability of DRLS. We found that
DRLS was reliable, to the extent that it accurately reflects
information provided by foreign drug manufacturing establishments that
register with FDA. However, we determined that these data do not
necessarily reflect all foreign establishments whose drugs are imported
into the United States. We do not present new information from DRLS in
this testimony.
[7] Biologics are materials, such as vaccines, derived from living
sources such as humans, animals, and microorganisms. Some biologics are
regulated by CDER and inspections related to those products are
included in our work.
[8] FDA regulations define manufacturing to include the manufacture,
preparation, propagation, compounding, or processing of a drug. 21
C.F.R. � 207.3(a)(8) (2007).
[9] GMPs provide a framework for a manufacturer to follow to produce
safe, pure, and high-quality products. See 21 C.F.R. pts. 210, 211
(2007).
[10] 21 U.S.C. � 360(h).
[11] A bulk drug substance is any substance that is represented for use
in a drug that, when used in the manufacturing, processing, or
packaging of a drug, becomes an active ingredient or a finished drug
product. 21 C.F.R. � 207.3(a)(4) (2007).
[12] ORA investigators lead inspections. Investigators are responsible
for performing or overseeing all aspects of an inspection. ORA
laboratory analysts are chemists or microbiologists and have expertise
in laboratory testing.
[13] When FDA receives an application for drug approval, officials
review the inspection history of each establishment listed on the
application. According to FDA officials, if an establishment listed on
the application has received a satisfactory GMP inspection in the 2
previous years and the agency has no new concerns, FDA will consider
this inspection sufficient and will not perform a preapproval
inspection of this establishment.
[14] FDA must approve an NDA in order for a new drug to be marketed in
the United States. FDA reviews scientific and clinical data contained
in these applications as part of its process in considering them for
approval to be marketed. Approval for a generic drug is sought through
an ANDA.
[15] In addition, FDA conducts for-cause inspections when it receives
information indicating problems in the manufacture of approved drug
products, as well as when it follows up on manufacturers that were not
in compliance with GMPs during previous inspections.
[16] Customs brokers are private individuals, partnerships,
associations, or corporations licensed, regulated, and empowered by CBP
to assist in meeting federal requirements governing imports and
exports.
[17] This count includes foreign establishments that were registered to
manufacture human drugs, biologics, and veterinary drugs; FDA was
unable to provide the number of registered establishments specifically
manufacturing human drugs.
[18] We updated information presented in our November 2007 testimony
because that data did not include complete counts of inspections
conducted in fiscal year 2007.
[19] FDA officials pointed out that some foreign establishments
register, for example, because registration may erroneously appear to
convey an "approval" or endorsement by FDA in foreign markets.
[20] GAO, Medical Devices: Challenges for FDA in Conducting
Manufacturer Inspections, [hyperlink, http://www.gao.gov/cgi-
bin/getrpt?GAO-08-428T] (Washington, D.C.: Jan. 29, 2008).
[21] 21 U.S.C. �� 379i(13); 379j(a)(3), (b), (h). The registration user
fee is $1,706 in fiscal year 2008 and will increase by 8.5 percent per
year, to $2,364 in fiscal year 2012. Fees are available for obligation
only to the extent and in the amount provided in annual appropriations
acts. FDA's authority to assess registration fees terminates on October
1, 2012.
[22] CDRH indicated that the center will deactivate the registrations
of those establishments that fail to complete the annual registration.
Officials noted that, in the past, many establishments that had
previously registered had not updated those registrations in several
years.
[23] According to CDRH, in April, the center will send letters to
establishments that have registered in the past but have not completed
their registration for fiscal year 2008 advising them that they must
register using the new system and must pay the registration fee, if
applicable, to be considered registered.
[24] 21 U.S.C. � 379i(8).
[25] The algorithm currently used by customs broker to assign the
manufacturer identification number does not provide for a number that
is reliably reproduced or inherently unique.
[26] The SEDS concept was developed by a working group with
representatives from FDA, the Environmental Protection Agency, and the
departments of Agriculture, Commerce, Defense, and Homeland Security.
[27] FDA officials told us that they do not use the results of an
inspection conducted by a foreign regulatory body to make decisions
about whether to approve a new drug.
[28] In addition to challenges in obtaining inspection reports, FDA may
also be limited by the type of information available. For example, FDA
may not be able to obtain inspection reports on API manufacturing
establishments because other regulatory bodies may only inspect
finished-dosage manufacturers.
[29] As a result of the inaccuracies in its data, FDA recognizes that
this list does not provide an accurate count of establishments subject
to inspection.
[30] According to FDA budget documents, the agency dedicated about $43
million to inspecting domestic drug manufacturers in fiscal year 2007.
[31] According to FDA, the cost of conducting foreign inspections
varies, depending on whether the type of inspection was a preapproval
or GMP surveillance inspection, by the time spent at an establishment,
by the number of FDA staff conducting the inspection, and by the costs
associated with traveling to the country in which the establishment is
located.
[32] FDA also proposed a reinspection user fee in its fiscal year 2007
and fiscal year 2008 budgets, but these proposals were not enacted.
[33] See, for example, Food and Drug Administration, Revitalizing ORA:
Protecting the Public Health Together In a Changing World (Rockville,
Md.: Jan. 2008).
[End of section]
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