| September 21, 2007 |  |
Congress Passes Law Improving FDA Drug Approval Process to Better Protect Consumers
Statement By Francesca Grifo, Union of Concerned Scientists
WASHINGTON (September 21, 2007) - Congress has given final approval to the Food and Drug Administration Revitalization Act, which will hold the FDA more accountable for the drugs it approves. The law requires the agency to publicize the basis for its decision, as well as whether there was any dissent and from whom. This will help ensure that the FDA relies on scientific research in making decisions about new drugs.
But the bill doesn't go far enough in restricting the number of people who serve on FDA advisory panels who have conflicts of interest. Nonetheless, the new law will improve the FDA's drug approval process and it sets the stage for similar reforms at other federal agencies.
Below is a statement by Francesca Grifo, senior scientist and director of the Scientific Integrity Program at the Union of Concerned Scientists (UCS).
"A year ago, when UCS surveyed nearly 1,000 FDA scientists, 20 percent of our respondents 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 that later proved to be harmful.
"This bill, now approved by both chambers of Congress, will make a difference. The bill contains transparency language that will shine a light on the FDA drug approval process, ensuring that the dissenting views of drug reviewers are heard and not suppressed and ignored. Transparency is the cornerstone of scientific integrity. We need sunlight to shine on the work of the FDA and all federal agencies to ensure that the work of scientists is not manipulated.
"The measure also protects scientists' right to publish their research, another way to safeguard the scientific integrity of FDA scientists and their work.
"Of course the ultimate test will be how well and comprehensively the FDA creates and implements regulations required by this bill. We will closely monitor the FDA's performance to ensure that the public gets full access to the information they need.
"This bill gives us a platform for reforms at many other federal agencies where science has been politicized and scientists intimidated. Survey after survey of federal scientists by UCS has uncovered similar problems at the U.S. Fish and Wildlife Service, NASA, National Oceanic and Atmospheric Administration, and the Environmental Protection Agency.
"The bill fails to go far enough to restrict the use of experts on FDA advisory panels who have financial ties to the makers of drugs and devices they are charged to review. The advisory panels should be a scientific review of FDA's work. Instead, the views of such panels often are dominated by experts who have financial incentives to push for drug approvals.
"Nevertheless, the bill's efforts to reduce the number of conflicted experts will put the FDA on notice that conflicts should be avoided. The bill also directs the FDA to recruit non-conflicted experts to serve on advisory panels. Independent science offers the public the best defense against unsafe drugs and medical devices and this bill takes us part of the way there."
The Union of Concerned Scientists puts rigorous, independent science to work to solve our planet's most pressing problems. Joining with citizens across the country, we combine technical analysis and effective advocacy to create innovative, practical solutions for a healthy, safe, and sustainable future.
