Health advocates push for FDA advisory reform

In a letter to acting FDA commissioner Lester Crawford, the groups said the agency failed to comply with the Federal Advisory Committee Act (FACA) when it assigned scientists with ties to manufacturers of COX-2 inhibitors to serve on a panel charged with evaluating those drugs.

Last month, the Center for Science in the Public Interest (CSPI) consumer group 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 But, according to The New York Times, the committee would have recommended that Bextra and Vioxx be withdrawn were it not for the votes of scientists with conflicts.

“The FDA is the ultimate arbiter of the safety and efficacy of industry products,” stated the letter signed by CSPI, the National Women’s Health Network, the Center for Medical Consumers, the US Cochrane Center Consumer Coalition, and eight other health-advocacy groups. “[FDA] relies on its advisory committees for guidance. No one financially connected to the firms whose products are up for consideration should be allowed to vote on what that guidance should be.”

CSPI and the groups are asking the FDA to exclude scientists currently or recently employed by companies with a direct stake in the committee’s proceedings, and have 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 groups are also calling for greater transparency and greater opportunities for public participation in the federal advisory committee process. They want the FDA to post biographies of proposed committee members online 30 days before committee meetings instead of 72 hours before, and to allow the public 20 days to comment on the proposed roster.

“No one would consider a jury’s verdict credible if a number of jurors had taken money from the defendant,” said Merrill Goozner, director of the Integrity in Science project at CSPI. “If the FDA wanted to restore public confidence in its decisions about the safety of food ingredients, drugs, and medical devices, it should reform the advisory committee process.”

Other signatories to the letter include the Reproductive Health Technologies Project, Breast Cancer Action, the Annie Appleseed Project, National Consumers League, the National Autism Association, SafeMinds, the National Research Center for Women and Families, and Our Bodies, Ourselves.