FDA floats new conflict policy

Advisers to America's top drug approval agency will have to provide more detailed information about financial interests they hold in pharmaceutical and medical device companies, the US Food and Drug Administration linkurl:announced;http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm209119.htm yesterday (21st April). The FDA grants conflict of interest waivers to some members of its 32 advisory committees, which convene to discuss food and drug safety issues, review impending approvals

Written byBob Grant

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The FDA grants conflict of interest waivers to some members of its 32 advisory committees, which convene to discuss food and drug safety issues, review impending approvals of specific drugs or devices, address particular disease areas, and provide opinions on policy matters. Since 2008, these waivers have been contingent upon the committee members disclosing to the agency if they work with a sponsor or competitor of a drug or medical device under FDA review, without providing more detail than that. But now, the agency is saying that committee members seeking a waiver must be prepared to go public with the names of those companies with which they have a relationship and the dollar amounts involved. "FDA is publicly disclosing the type, nature, and magnitude of any waived financial interests," read the agency's linkurl:draft guidance.;http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM209201.pdf The "magnitudes" mentioned in the guidance, however, are broad ranges -- for example, $0-5000 or $5001-$10,000 -- instead of specific dollar amounts. The public will be able to comment on the proposal for the next 60 days. Go linkurl:here;http://edocket.access.gpo.gov/2010/2010-9313.htm to read more about the guidance and instructions on how to submit comments. (Go linkurl:here;http://www.regulations.gov/search/Regs/home.html#home to post comments electronically.) "In my view, it is clearly better for the agency in fulfilling its public health mission when advisors have no conflicts of interest," FDA Commissioner linkurl:Margaret Hamburg;http://www.fda.gov/AboutFDA/CommissionersPage/default.htm said in a letter to senior agency officials, linkurl:posted;http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm209001.htm on the agency's website. "At the same time, however, I recognize the fact that many of the top authorities in specific areas may have conflicts of interest."
**__Related stories:__***linkurl:Conflicts brewing at the FDA;http://www.the-scientist.com/blog/display/55887/
[13th August 2009]*linkurl:FDA stinks at policing conflicts;http://www.the-scientist.com/blog/display/55330/
[12th January 2009]*linkurl:FDA rolls out new conflict rules;http://www.the-scientist.com/blog/display/54914/
[5th August 2008]

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Bob Grant

From 2017 to 2022, Bob Grant was Editor in Chief of The Scientist, where he started in 2007 as a Staff Writer. Before joining the team, he worked as a reporter at Audubon and earned a master’s degree in science journalism from New York University. In his previous life, he pursued a career in science, getting a bachelor’s degree in wildlife biology from Montana State University and a master’s degree in marine biology from the College of Charleston in South Carolina. Bob edited Reading Frames and other sections of the magazine.

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