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Pharma ties to FDA committee members to get greater scrutiny

Pharma Compliance Alert, July 26, 2006

The FDA is taking a closer look at its process for letting people with drug industry ties serve on its advisory committees. Although the FDA says its approach for granting waivers to serve to experts with industry ties is rigorous, it has been criticized for being not transparent enough.

Under its new plan, the FDA says it will draft guidance to identify more clearly how waivers are granted and when they will be disclosed to the public. The FDA also plans to make the entire advisory committee process more transparent. For example, it said it will issue guidance about when certain materials used during committee meetings will be made publicly available and more widely publicize committee schedules.

The Center for Drug Evaluation and Research is will also assess its use of advisory committees, including the process of choosing members and developing the agenda.

The FDA's move to add transparency to its advisory committee process comes just weeks after the Journal of the American Medical Association tightened its conflict of interest policy because a group of study authors didn't disclose all financial ties to the drug industry.

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