April 3, 2007 The Pump Handle 0Comment

By David Michaels

The campaign by policy experts to have Congress end the user fee system that funds FDA is picking up steam. The Prescription Drug User Fee Act (PDUFA) allows FDA to collect money from drug makers in exchange for faster reviews of their new products. But PDUFA makes the FDA dependent on the drug makers for a big piece of its budget, and the money comes with lots of strings – especially ones that limit FDA’s spending on drug safety. (Here is last week post on the NY Times editorial opposing PDUFA.)

In today’s Washington Post Cindy Skrzycki’s The Regulators column has a terrific piece on the letter written by leading drug safety and policy experts asking Congress to end PDUFA. Clearly, FDA needs the money PDUFA brings in; in fact, it needs a much higher level of funding to do its job right. So we have asked Congress for a temporary reauthorization, without PDUFA’s handcuffs, until the agency can be supported with appropriated money.

If PDUFA must be reauthorized to ensure an adequate FDA budget, the signers recommend that it be re-authorized for no more than one year and that it include the following characteristics:
• Allow FDA leadership to determine how the agency allocates the fees collected to fulfill all aspects of its mission.
• Deadlines or targets for speed of review must be eliminated or modified to allow flexibility and adequate time for evaluation and analysis by reviewers.
• New performance goals must be linked with safety or other public health outcomes, not just speedy approval decisions.
• Adequate resources must be made available for scientific research and training for FDA scientific and medical staff, including in drug safety epidemiology and risk management.

The press is reporting that key legislators have not publicly committed to reauthorizing PDUFA:

House Energy and Commerce Committee Chair John Dingell (D-Mich.) “is going to reserve judgment” on the proposal from FDA, a Dingell spokesperson said, adding, “We want to allow our members a chance to learn more about the proposal.”

With Big PhRMA lobbying for it, the odds on stopping PDUFA aren’t great. But times (and the Congress) have changed. As the problems of PDUFA become more apparent, I think many members of Congress will agree that the program served a useful purpose 15 years ago, but now it is part of the drug-safety problem rather than part of the solution.

David Michaels heads the Project on Scientific Knowledge and Public Policy (SKAPP) and is Professor and Associate Chairman in the Department of Environmental and Occupational Health, the George Washington University School of Public Health and Health Services.

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