Injury News

Health Advocates Call for Reform of FDA Advisory Committees

Source: Center for Science in the Public Interest

“Stop placing scientists with direct financial conflicts of interest” on Food and Drug Administration advisory committees, health advocates wrote in a letter to Acting FDA Commissioner Lester Crawford.

In the letter dated March 10, 2005, the groups said the agency failed to comply with the Federal Advisory Committee Act (FACA) when it assigned scientists with ties to manufacturers of arthritis pain drugs known as Cox-2 inhibitors, including Vioxx and Celebrex, to serve on a panel charged with evaluating those drugs.

Last month, Center for Science in Public Interests (CSPI) found that of 32 experts serving on the FDA’s Arthritis Drug and Drug Safety Advisory Committee, 10 had received funding from Pfizer, Merck, or Novartis. At the end of the three-day meeting designed to assess the cardiovascular risk presented by these drugs, the panel voted to keep all of those drugs on the market. But according to The New York Times, the committee would have recommended that Bextra and Vioxx be withdrawn were it not for the votes of scientists with conflicts.

“No one financially connected to the firms whose products are up for consideration should be allowed to vote on what that guidance should be,”states the letter signed by CSPI, the National Women’s Health Network, the Center for Medical Consumers, the U.S. Cochrane Center Consumer Coalition, and eight other health-advocacy groups.

The groups urged the FDA to stop granting waivers that allow conflicted scientists to serve. In the case of the Cox-2 review panel, the FDA issued a blanket waiver summarily covering every scientist on the panel. None of those scientists’ financial ties to industry were disclosed prior to or during the meeting.

“The FDA has become so reliant on scientists connected with industry that it routinely grants waivers for conflicts of interest, not just in exceptional cases,” said Amy Allina, program director of the National Women’s Health Network.

The groups are also calling for greater transparency and for greater opportunities for public participation in the federal advisory committee process.