Drug Agency’s Advisers Are ‘Rubber Stamps,’ U.S. Group Says

Bloomberg: August 28, 2006

The U.S. Food and Drug Administration’s outside advisory panels typically serve as “rubber stamps” for companies seeking approval of drugs and medical devices, according to a nonprofit research group.

Eleven randomly selected FDA advisory committees recommended approval in 79 percent of their votes on applications between 1998 and 2005, according to the study released today by the Washington-based National Research Center for Health Research. The committees considered 89 products during that period.

“Some of the committees have never met a product they don’t like,” said Diana Zuckerman, president of the group, said in a telephone interview. “From a consumer point of view, this is not good news.”

Members of Congress including Senator Charles Grassley, an Iowa Republican, have criticized the FDA for failing to sufficiently scrutinize drug safety. Public interest groups and lawmakers also have said the FDA has appointed doctors and scientists to advisory committees who have financial or other relationships with the companies whose products they consider.

The FDA said in July that it plans to write new guidelines specifying when scientists and doctors serving on the panels should be disqualified because of conflicts of interest. Under FDA rules, the agency can grant waivers for those with conflicts, allowing them to serve on panels.

The FDA convenes the committees to provide advice when the agency has questions on applications to clear new drugs or medical devices or additional uses for products already sold. The agency, while not bound by the recommendations, often follows the panels’ advice.

FDA Clearance

The center’s report found that “even lopsided votes against approval apparently do not have much weight, since the FDA subsequently approved many of those products.”

The agency’s decisions “are made on the totality of the scientific data,” said FDA spokeswoman Kathleen Quinn. “While this includes the recommendations made by the advisory committees, it is not the only thing and therefore does not automatically guarantee an approval decision.”

The research center randomly selected six of 16 drug advisory committees and five of 18 medical-device committees. The products considered during that time included drugs for arthritis and erectile dysfunction and devices for laser eye surgery and improving the accuracy of mammograms, the study said.

The device panels recommended approval 82 percent of the time compared with 76 percent for drug-review panels, the study found. Some committees were more likely to suggest approval than others, ranging from 50 percent for the committee that reviews reproductive drugs to 100 percent for the panel dealing with arthritis medications.


To contact the reporter on this story:

Justin Blum in Washington at (1) (202) 624-1861 or jblum4@bloomberg.net.