Congressional Hearings Focus on Foreign Inspection Process

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ePT--the Electronic Newsletter of Pharmaceutical Technology

Congress is taking on the issue of inspection of foreign drug-manufacturing facilities as it began hearings on a discussion draft of the Food and Drug Administration Act of 2008.

Washington, DC (Apr. 22)-Congress took on the issue of inspection of foreign drug-manufacturing facilities as it began hearings on a discussion draft of the Food and Drug Administration Globalization Act of 2008.

Earlier this month the House Committee on Energy and Commerce circulated a discussion draft of the Food and Drug Administration Globalization Act of 2008. Among the measures under consideration are requirements for: parity between foreign and domestic inspections of drug-manufacturing facilities, registration fees to finance the cost of inspections, annual registration of drug-manufacturing facilities operating in the United States or exporting products to the US, and country-of-origin labeling of active pharmaceutical ingredients (APIs).

Last week, Marcia Crosse, director of health of the US Government Accountability Office (GAO), testified before the House Subcommittee on Oversight and Investigations, Committee on Energy and Commerce to assess FDA’s progress in its foreign drug-inspection process. Testimony by the GAO in November 2007 was largely critical of FDA’s resources and ability to adequately conduct foreign inspections.

“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,” said Crosse.


Once such weakness concerns FDA’s current databases of manufacturing facilities subject to inspection. GAO had earlier testified that these databases do not accurately count the number of foreign drug-manufacturing facilities.

“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 inspections,” said Crosse.

“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 for the US market from erroneously registering with FDA.”

Crosse said it was still too early to evaluate an FDA proposal for the Foreign Vendor Verification Program, which could help improve the accuracy of information FDA maintains on foreign establishments. Under the program, FDA plans to contract with an external organization to conduct on-site verification of registration data and product-listing information for foreign establishments shipping drugs to the United States. As of April 2008, FDA 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 or how many establishments would be visited, says Crosse. FDA plans to award this contract in May 2008.

FDA is also planning to create a government-wide unique establishment identifier as part of the Shared Establishment Data Service (SEDS) to address the problem of unreliable identification numbers generated by custom brokers when the product is offered for entry into the US. SEDS would provide a unique establishment identifier and a centralized service to provide commercially verified information about establishments. Crosse pointed out the implementation of SEDS is dependent on action from multiple federal agencies, including the integration of the system into a CBP import and export system that is currently under development and scheduled for implementation in 2010.

Crosse also said that although FDA has made progress in conducting more foreign inspections, it still inspects relatively few establishments. According to GAO, FDA conducted 332 inspection of foreign drug-manufacturing facilities in fiscal year (FY) 2007, which was an improvement compared with FY 2006, when FDA conducted 212 inspections of foreign drug facilities, and with FY 2005, when FDA conducted 266 inspections.

For Crosse’s complete testimony, click here.

For more on this topic, see:

Congress Moves to Improve FDA’s Inspection Process