Opposition to current drug safety legislation is growing, as a group of 22 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. 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.
User fees may appear to save the taxpayer money, but at an unacceptable cost to public health, the letter from the 22 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. The letter is also signed by drug safety expert Dr. Jerome Avorn; four IOM panel members including Dr. Bruce Psaty and Prof. Alta Charo; three former Editors-in-Chief of the New England Journal of Medicine, Dr. Marcia Angell, Dr. Jerome Kassirer, and Dr. Arnold Relman; and former Asst. Secretary for Health Phil Lee, along with other 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
Contact: Susan Wood
George Washington University