Breaking FDA's User Fee Habit (2)

By David Michaels

The Prescription Drug User Fee Act (PDUFA), through which the FDA collects money from drug makers in exchange for faster reviews of their new products, gets skewered again â this time in a piece by Christopher Moraff in the American Prospect Online. (We've been covering the issue here at TPH; more materials on the link between PDUFA and the drug safety crisis are also posted on DefendingScience.org).

Following hot on the heels of yesterdayâs Washington Post/Bloomberg critique by Cindy Skrzycki, Moraff summarizes the shortcomings of PDUFA raised by the Institute of Medicine, the Government Accountability Office, and the letter sent by 22 experts on drug safety and regulation asking Congress not to reauthorize PDUFA:

User fees are not uncommon in federal agencies, but critics of PDUFA say that what distinguishes it is an unprecedented level of collaboration between the FDA and the pharmaceutical industry. Through protracted fee negotiations, the industry has a say in everything from how the money will be spent to setting up timetables for a drug's approval -- the equivalent, according to one former chief editor of The New England Journal of Medicine, of "putting the fox in the chicken coop."

Moraff raises the obvious concern: Big Pharmaâs power. âWith a Democratic Congress at the helm, it's likely the FDA will face some tough questioning in the coming months. Still, the pharmaceutical lobby has millions of dollars at its disposal. And in America you tend to get what you pay for.â But the drug manufacturers may not oppose eliminating PDUFA. Skrzycki reports that

Scott Lassman, senior assistant general counsel for the Pharmaceutical Research and Manufacturers of America, the industry's lobby group, said drugmakers would be happy to have Congress fully fund the FDA. Yet Lassman added, 'That is not going to happen, so we are willing to step up.''

The FDA needs a source of revenue for next year, so simply not reauthorizing PDUFA without an alternative source of funding is not possible. But there is an easy solution. In our letter, we advised Congress that if PDUFA must be reauthorized this year, it should be reauthorized for one year only:

This limited reauthorized PDUFA should be structured to enable the FDA to do the best job it can in advancing the health of Americans. Any reauthorized PDUFA must have 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 FDAâs mission is to protect and advance the publicâs health. PDUFA stands in the way of this objective.

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.