Congress, FDA Weigh in on Measures to Improve Drug Safety

Washington, DC (May 1)-Congressional hearings were held last week on the Food and Drug Administration Globalization Act discussion draft. 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.

FDA said that it is still reviewing the discussion draft but emphasized several key points. “We believe the proposed legislation should be more closely targeted and prioritized according to risk,” said Janet Woodcock, director of the Center for Drug Evaluation and Research at FDA, in testimony before the Subcommittee on Health of the House Energy and Commerce Committee. “Several of the legislative sections appear not to be sufficiently focused on high-risk products. Some of these requirements would divert resources, which could detract from important drug safety and security priorities. In addition, the legislation should more explicitly incorporate the Administration’s strategy of leveraging third party certification and efforts by foreign nations already underway.”

Woodcock added that any legislation should allow FDA to set requirements and priorities based on “a strong scientific FDA risk assessment. FDA cannot rely on inspection as its primary means of ensuring product safety,” she said. “Any legislation should build on the framework in the Action Plan for Import Safety, i.e., building in safety measures to address risks throughout a product’s life cycle and focus efforts on preventing problems first, and then using risk-based interventions to ensure preventive approaches are effective, coupled with a rapid response as soon as a problem is detected.”

The cost of bringing inspections of foreign drug-manufacturing facilities in line with inspections of domestic facilities was also raised. “An important step toward addressing this crisis occurred at the hearing on Tuesday [April 29, 2008]. During that hearing, Woodcock candidly acknowledged the need for substantial new funding for inspections and stated that at least $225 million would be needed to put foreign facilities inspections on par with inspections of domestic drug firms,” said Congressman John D. Dingell (D-MI), Chairman of the House Committee on Energy and Commerce, who introduced the discussion draft.

But in later comments Woodcock offered a more general view of registration fees. “While the Administration is supportive of user fee programs in which regulated industry provides funding for additional performance and efforts or programs designed to recoup the costs of regulatory actions resulting from findings of violations (such as reinspections), the Administration will carefully review any proposed user fee program to ensure that it is being assessed against identifiable recipients of special benefits derived from Federal activities beyond those received by the general public,” she said in prepared testimony.

Lori Reilly, vice-president for policy and research at the Pharmaceutical Research and Manufacturers of America (PhRMA), also weighed in on the debate. “PhRMA agrees with the Committee that the rate of FDA foreign inspections should be increased and recommends that FDA utilize a risk-based approach to prioritize such inspections,” she said. At the hearing, PhRMA also stressed the importance of Congress increasing appropriated funds to help the FDA fulfill its mission of protecting patient health and safety.

Read the statement of John D. Dingell, Chairman of the House Committee on Energy and Commerce.
Read the statement of Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research.