Congress approvs bill holding the FDA more accountable
In January 2008, the president signed the Food and Drug Administration Revitalization Act, a bill that will significantly improve the drug review process at the Food and Drug Administration (FDA) and hold the FDA more accountable, protecting us from unsafe drugs. The law includes transparency language that will shine a light on the FDA drug approval process. By opening up the drug review process and documents to public scrutiny, the manipulation of research results becomes much more apparent and thus easier to counteract.
This legislative victory is crucial to public health and safety. Last year, when UCS surveyed nearly 1,000 FDA scientists, one in five reported that they had been asked by their supervisors to provide the public, the news media, and government officials "incomplete, inaccurate, or misleading information." When the unbiased research of qualified scientists was suppressed and distorted, flawed data led the FDA to approve drugs such as Vioxx, Avandia, and Ketek, which later proved to be harmful.
This bill requires that the views of drug reviewers are heard and not suppressed or ignored. In addition, the bill also protects scientists' right to publish their research, another way to safeguard the scientific integrity of FDA scientists and their work. Unfortunately the bill doesn't go far enough to restrict conflicts of interest on FDA advisory panels. Nonetheless, the new law will improve the FDA's drug review process and set the stage for similar reforms at other federal agencies.
Throughout the long legislative process, UCS activists kept the pressure on Congress. Activist phone calls and emails helped UCS demonstrate public support for reform. The law sets a precedent for increased public scrutiny of science-based decision making at other federal agencies. UCS will monitor the way the FDA implements the new legislation.
UCS surveys have revealed similar problems at the U.S. Fish and Wildlife Service, NASA, and the National Oceanic and Atmospheric Administration. To see more information about UCS surveys of scientists at federal agencies, click here.
