Press Release and Letter to Congress about Drug Safety and FDA

National Experts and Nonprofit Organizations
Urge Major Changes To “FDA Reform” Legislation

March 14, 2007

Washington, DC — Opposition to current drug safety legislation is growing, as a group of 21 experts on drug safety and regulation and a coalition of 12 patient, consumer, science, and public health organizations issue two separate open letters to lawmakers. Released to coincide with a Senate hearing on drug safety, the letter from FDA experts asks the lawmakers to not reauthorize the user fees system that finances the review of new drugs by the Food and Drug Administration (FDA). The letter from the coalition of nonprofit organizations calls for substantial changes to the Enhancing Drug Safety and Innovation Act introduced by Senators Kennedy and Enzi.

Both letters are addressed 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. The Enhancing Drug Safety and Innovation Act is a separate bill that may be combined with PDUFA.

“User fees may appear to save the taxpayer money, but at an unacceptable cost to public health,” the letter from the 21 experts warns, citing findings of a panel of experts recently convened by the Institute of Medicine (IOM) to address drug safety at the FDA. They call for Congress and the nation to carefully reassess 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. 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 is also signed by Dr. Jerome Avorn of Harvard, IOM panel members Dr. Bruce Psaty and Prof. Alta Charo, Dr. Marcia Angell, Dr. Jerome Kassirer, former Asst. Secretary for Health Phil Lee, and other well-respected experts from medicine, academia, and public policy.

The letter from the coalition of patient, consumer, science, and public health organizations agrees that PDUFA is undermining patient safety, and criticizes a drug safety bill introduced by Senators Kennedy and Enzi, stating it “does not include the provisions necessary to prevent another Vioxx, Accutane, or Ketek from reaching the market and harming patients and their families. The bill needs to be strengthened to protect consumers from the dangers of unreported drug risks and to safeguard against future drug safety disasters.”

Both letters cite the need for reforms suggested by the IOM panel, which found that the FDA’s drug safety system is impaired by resource constraints, problems with organizational culture, and unclear and insufficient regulatory authority. The FDA experts conclude that the IOM report shows 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, the risks of drugs already on the market receive little attention, and FDA has very limited resources to conduct post-marketing drug safety surveillance. Recent polls show that public confidence in the FDA is at an all-time low.

“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 resigned her position at the FDA’s Director of the Office of Women’s Health and Assistant Commissioner for Women’s Health in 2005 over the agency’s failure to support FDA scientists’ recommendation to approve Plan B emergency contraception for over-the-counter sale.

Recommendations contained in the experts’ 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, convened by the project on Scientific Knowledge and Public Policy at the George Washington University, where Dr. Wood is on the faculty. If PDUFA must be reauthorized to ensure an adequate FDA budget, the FDA experts 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 coalition letter urges Congress to make public health goals a priority, strengthening safeguards that have been weakened under PDUFA. The signers of both letters agree, “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.”

“It is disturbing that the FDA would consider approving these devices despite the lack of data for breast cancer patients,” said Dr. Susan Wood, former director of the FDA’s Office of Women’s Health.

The complete text of the letters and list of signers is available at and For more information about the FDA experts’ letter, contact Dr. Susan Wood. For more information about the letter from the 12 patient, consumer, science, and public health organizations, contact Hydi Miller.