Sunday, July 30, 2006

New FDA Guidelines on Experts

The FDA announced new guidelines on experts on advisory committees with ties to industry last week.  Among other things:

* [The FDA will be] Issuing guidance on identifying more clearly the conditions under which conflict of interest waivers are granted. The FDA said that at present it grants waivers after taking into consideration the participation in scientific endeavors related to the work of the committee.

* The FDA also said that it would frame guidelines on when the conflict of interest should be disclosed to the public and on what the nature of this disclosure should be.

* The agency also wants certain rules specifying when briefing materials used at FDA advisory committee meetings will be made publicly available.

* The FDA also said it would look at making the whole process transparent and send information on the advisory panels to public groups and providing electronic notifications through an FDA advisory committee list serve and posting on the FDA web site.

* The agency also promised to streamline the appointment of drug-related advisory committees.

It's not immediately clear to me how broadly the FDA considers conflicts -- e.g., whether someone without industry ties but who has made, say, $500,000 in the last year testifying for plaintiffs' attorneys would count.

http://lawprofessors.typepad.com/tortsprof/2006/07/new_fda_guideli.html

Experts & Science, Products Liability | Permalink

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