FDA Advisory Panels Biased Toward Drug Approvals

The panels of experts assembled by the Food and Drug Administration to advise it on whether to approve new drugs and medical devices are often biased in favor of recommending approval, according to a consumer group's analysis released yesterday.

The advisory panels often vote unanimously to recommend approval even after members express doubts about the product or say the evidence submitted is insufficient, said the report by the National Research Center for Women & Families, a policy research and advocacy group. The FDA has recently come under fire over drug safety issues, including its decisions to approve the popular arthritis pain medications Vioxx and Celebrex that were later associated with an increased risk of heart attacks and strokes.

The group's report also said the FDA is more likely to accept its panels' advice when they recommend approving a product than when they vote against approval.

From: The Washington Post
Tuesday, August 29, 2006; Page A13