FDA floats new conflict policy
Posted by Bob Grant, "The Scientist.com"
22nd April 2010
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 announced 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 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 "FDA is publicly disclosing the type, nature, and magnitude of any waived financial interests," read the agency's draft guidance. 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 here to read more about the guidance and instructions on how to submit comments. http://edocket.access.gpo.gov/2010/2010-9313.htm Go here to post comments electronically http://www.regulations.gov/search/Regs/home.html#home
"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 Margaret Hamburg said in a letter to senior agency officials, posted 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."
Posted by Bob Grant, "The Scientist.com"
22nd April 2010
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 announced 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 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 draft guidance. 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 here to read more about the guidance and instructions on how to submit comments. http://edocket.access.gpo.gov/2010/2010-9313.htm Go here to post comments electronically http://www.regulations.gov/search/Regs/home.html#home
"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 Margaret Hamburg said in a letter to senior agency officials, posted 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."