By David Michaels
It is starting to feel like a groundswell. Last week, a group of 22 experts on drug safety and regulation issued an open letter to lawmakers asking Congress not to reauthorize the Prescription Drug User Fee Act (PDUFA), the system that funds the Food and Drug Administrationâs drug review process. In that letter, we wrote âuser fees may appear to save the taxpayers money, but at an unacceptable cost to public health.â
Yesterday, at a House Energy and Commerce Oversight and Investigations Subcommittee hearing, chaired by Rep. Bart Stupak (D-MI) , several members suggested PDUFA should be eliminated. Rep. Diana DeGette (D-CO) referenced a public meeting at which four former FDA commissioners agreed that the nation would be better served if Congress directly appropriated the money rather than relying on user fees and the accompanying constraints imposed by PDUFA. And Rep. Rosa DeLauro (D-CT), who chairs the appropriations subcommittee that funds the FDA, asserted that the balance between federal funds and user fees must be reconsidered.
The lead editorial in todayâs New York Times also gets it right:
Congress needs to confront another worrisome source of industryâs influence: the $300 million in annual fees paid by pharmaceutical manufacturers that help finance the approval process and regulation of drugs. Critics have long complained that these user fees distort the agencyâs objectivity and make for a too cozy atmosphere between the industry and its regulators.
The Bush administration, unfortunately, is seeking to increase reliance on user fees. Thatâs the wrong direction to go. To ensure that the publicâs interests are its only concern, the F.D.A. should be supported entirely by public funds.
Once you look at this issue, it is hard to escape the conclusion that user fees are part of the problem, not part of the solution to the drug safety crisis. If Congress does not want to give up the $400 million, then have the user fees deposited directly into the US Treasury, and give the FDA enough appropriated dollars to do its job right.
For more information, check out our web page on the link between PDUFA and drug safety.
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.