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

Bob Grant

| 2 min read

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is publicly disclosing the type, nature, and magnitude of any waived financial interests," read the agency's linkurl:draft guidance.;http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM209201.pdf The "magnitudes" mentioned in the guidance, however, are broad ranges -- for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]

FDA floats new conflict policy

The Scientist ARCHIVES

Become a Member of

Meet the Author

Bob Grant

Related Research Resources

Why Do Some People Get Drunk Faster Than Others?

Research Resources

Podcasts

Webinars

Videos

Infographics

eBooks

Sex Differences in Neurological Research

New Frontiers in Vaccine Development

New Approaches for Decoding Cancer at the Single-Cell Level

Organoids as a Tool for Tissue Regeneration Research

Products

Product News

Artificial Inc. proof-of-concept data demonstrates platform capabilities with NVIDIA’s BioNeMo

Sapient Partners with Alamar Biosciences to Extend Targeted Proteomics Services Using NULISA™ Assays for Cytokines, Chemokines, and Inflammatory Mediators

Bio-Rad Extends Range of Vericheck ddPCR Empty-Full Capsid Kits to Optimize AAV Vector Characterization

Accelerating Mycoplasma Testing for Targeted Therapy Development