After Heparin: - The Pew Charitable Trusts

—Chapter 2—
2.5 Pew conference and policy
recommendations
At the Pew Health Group roundtable conference (March 14 and 15, 2011; see Appendices B and C
for list of attendees and full agenda), participants agreed that it is important to improve the FDA’s oversight
of foreign manufacturing. There was clear agreement among generic and brand industry representatives,
API producers and consumer groups that inspections of foreign facilities should occur at the
same rate as U.S. facility inspections and should be prioritized based on risk, as recommended by the
GAO. One industry participant argued strongly that regulatory inspections should be unannounced
whenever possible.
Several participants argued that the FDA must leverage the capacity of third parties, particularly other
regulatory agencies, to achieve needed increased oversight. Suggestions included conducting cooperative
inspections, reciprocal recognition of inspections by other qualified regulatory agencies and use of
independent accredited inspectors. An industry participant suggested that the FDA could immediately
alleviate resources by reducing its inspectional activity in the E.U. by relying on the results of inspections
carried out by European regulators. One specific suggestion to the FDA was that the agency should
participate in EudraGMP, a database launched by the European Medicines Agency in 2007 that catalogs
suppliers with E.U. GMP certificates. A GAO official similarly encouraged the agency to take advantage
of as much third-party information as is available.
FDA Deputy Commissioner John Taylor indicated that the FDA intends to make better use of third-party
sources of information, and sought improved collaboration with foreign regulatory counterparts. The
GAO called the FDA’s effort to set up foreign offices a good first step, but noted that the staff in those
new, small offices needs better feedback from headquarters on what it should be doing and how to manage
a workload that can become overwhelming.
Representatives of generic drug and active-ingredient manufacturers spoke in support of new industry
fees to cover the costs of increased foreign inspections and create a level playing field for U.S.-based
manufacturers. However, a representative of the Pharmaceutical Research and Manufacturers of America
(PhRMA) suggested that, while user fees have worked well in other contexts, Congress should offer
additional appropriations so that the FDA can better oversee globalized manufacturing. FDA officials
suggested that a potential ancillary benefit of facility registration fees would be to disincentivize foreign
plants that do not export to the United States from registering with the FDA purely to obtain a “seal
of approval.” When such fees were introduced for medical devices, the number of registered facilities
dropped by one-third. 448
Stakeholders also discussed measures to improve the FDA’s knowledge of foreign manufacturers and
imported products. The GAO speaker delineated challenges to the FDA’s database systems for overseas
plants and emphasized the need to improve information entry for imported products at the border. The
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Pew Health Group