U.S. Senate Votes to Scrutinize FDA Panels

Under a measure passed unanimously by the U.S. Senate, the Food and Drug Administration (FDA) would have to publish a list of "waivers," and the reasons for granting them.

The FDA often grants waivers allowing outside experts to serve on advisory panels even if they have ties to manufacturers that could present a conflict of interest. The panels give recommendations about whether new medicines should be approved. Among other things, this list of waivers will disclose the industry ties of advisory committee members fifteen days prior to their meetings.

The agency also must go out of its way to explain the efforts it takes to find advisers without conflicts or questionable connections to the Department of Health and Human Services inspector general. The reasoning behind this senatorial move is to create a powerful incentive to do more to find scientists without the potential for bias.

In response, the FDA said it is working on new ways to make information concerning proceedings readily available so that stakeholders can better understand how the conflicts of interest arise. The FDA has already taken some measures, such as promising to present information at the start of panel meetings as well as posting transcripts on the FDA Website in the weeks following a meeting.

The issue gained attention in February after a meeting about risks of painkillers such as Merck & Co. Inc.'s recalled drug Vioxx. Ten of 32 advisers who supported future sales of Vioxx and pain relievers Celebrex and Bextra had acted as paid consultants for the drug makers in recent years. This data was provided by an independent consumer analysis group. The senators also noted that there are allegations currently under review that one member of an advisory panel for the safety of silicone-gel breast implants got payments from the device industry. FDA did not find that the payments posed a significant conflict of interest, a conclusion that caused a stir.

The measure, passed unanimously by the Senate, was an amendment to a bill appropriating funds for the FDA and other agencies. Before they become law, the FDA provisions need to be reconciled with a House of Representatives version that prohibits scientists with industry ties that may pose a conflict of interest from serving on advisory panels, and be signed by the President.

Article References
U.S. Senate votes for more information on FDA panels, site accessed on 08/22/05

Bill would add more scrutiny of FDA panels, site accessed on 08/22/05