U.S. Congress steps up drug safety

Congress has given final approval to 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.Thanks in part to public action, calls and letters, 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.

Transparency is the cornerstone of scientific integrity—it’s vital to the work of the FDA and all federal agencies to ensure that the work of scientists is not manipulated.

The Union of Concerned Scientists will closely monitor the FDA’s performance, tracking whether the public gets full access to the information they need. And they will again rely public support as they continue to push for similar reforms at other federal agencies where science has been politicized and scientists have been intimidated.

UCS surveys have revealed similar problems at the U.S. Fish and Wildlife Service NASA, and theNational Oceanic and Atmospheric Administration.