FDA seeks new disclosure from panel members

  • Updated: April 21, 2010 - 9:17 PM

The U.S. Food and Drug Administration would disclose which companies or institutions create a potential conflict of interest for advisory panel members, under a proposal posted Wednesday on the agency's website.

The measure would replace a policy, in effect since August 2008, that requires outside advisers only to say whether they work with a sponsor or competitor of a drug or medical device under review, without being more specific. The agency said it would take public comments on the proposal for two months.

The FDA will indicate the magnitude of financial ties by a dollar range, such as $0 to $5,000, with a company or institution related to an issue before an advisory panel. The FDA can grant waivers of conflict of interest for up to 13 percent of advisers participating in meetings under current law. Greater scrutiny isn't expected to dissuade qualified experts from serving on panels, the agency said Wednesday.

"By making fully informed decisions when considering waivers of conflict of interest, and by improving the transparency of those waivers that are granted, FDA can both obtain needed input and maintain external credibility," FDA Commissioner Margaret Hamburg said Wednesday in a letter posted on the agency's website.

The agency pays panel members to meet several times a year to recommend approval, rejection or more research on medical products.

The FDA currently grants waivers of conflict of interest for less than 5 percent of advisory panel members Hamburg said in her letter Wednesday. The FDA usually follows the advice of its advisers, though it isn't required to do so.

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