PDF of press release

March 14, 2007 - A group of 22 experts on drug safety and regulation has issued an open letter to lawmakers asking them not to reauthorize the user fees system that finances the review of new drugs by the Food and Drug Administration (FDA).

The signers addressed their letter to Chairman Edward Kennedy and Senator Mike Enzi of the Senate Committee on Health, Education, Labor, and Pensions, and Chairman John Dingell and Representative Joe Barton of the House Committee on Energy and Commerce. These committees are considering the reauthorization of the Prescription Drug User-Fee Act (PDUFA), under which brand name drug manufacturers pay a fee for each new drug the agency reviews.

“User fees may appear to save the taxpayers money, but at an unacceptable cost to public health,” the letter warns, citing findings of a panel of experts recently convened by the Institute of Medicine (IOM) to address drug safety at the FDA.  Four of the letter’s signers served on that IOM panel, and six signers are former top staff of FDA or the Department of Health and Human Services.

The letter’s signers call for Congress and the nation to carefully re-assess the system in which drugs are developed, tested, approved and followed post-approval, and they support replacing the current user fee model with increased direct appropriations for the FDA.

The IOM panel found that the FDA’s drug safety system is impaired by resource constraints, problems with organizational culture, and unclear and insufficient regulatory authority. It reported that “FDA, contrary to its public health mission, and the pharmaceutical industry, contrary to its responsibility to the users of its products (and its shareholders), do not consistently demonstrate accountability and transparency to the public by communicating safety concerns in a timely and effective fashion.”

Unlike other user fee programs in the federal government, PDUFA is negotiated with representatives of fee payers – in this case, the Pharmaceutical Research and Manufacturers of America (PhRMA). Under this arrangement, risk management for drugs already on the market receives little attention, and FDA’s ability to conduct post-marketing drug safety surveillance is limited. Safety problems with high-profile drugs such as Vioxx have eroded public confidence in the agency.

“The FDA lacks the resources and authority it needs to carry out its duty of safeguarding public health,” says Susan F. Wood, PhD. “FDA needs both legislation and leadership to enact the much-needed reforms recommended by the IOM panel and others.” Wood served for several years as the FDA's Director of the Office of Women’s Health and Assistant Commissioner for Women’s Health and resigned her post in 2005 over the continued delay of approval of Plan B emergency contraception for over-the-counter sale.

In her current position with the Project on Scientific Knowledge and Public Policy (SKAPP) at George Washington University, Wood directs SKAPP’s project on strengthening the FDA. Recommendations contained in the open letter came out of two events – a panel discussion featuring four former FDA commissioners and an expert workshop – held last month on that topic.

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 letter concludes, “The FDA’s mission is to protect and advance the public’s health. As it currently exists, and would exist in its proposed form, PDUFA stands in the way of this objective.”

The complete text of the letter and list of signers is available at www.defendingscience.org/newsroom.

Related Materials
PDF of open letter
PDF of press release
Former FDA Commissioners Panel Discussion (also see transcript and selected quotes from this event)
The Impact of Prescription Drug User Fees on Drug Safety - Reports and Analyses
"FDA 'Addiction' to User Fees Comes Under Attack" - Bloomberg News column by Cindy Skrzycki
"Safety First" - The American Prospect Online article by Christopher Moraff
Blog posts about PDUFA on The Pump Handle
Rosa DeLauro on "The Future of the FDA"