News:FDA Advisors Under Review for the Potential of Financial Conflict

August 8, 2007 By Grendel Burrell [mailto:grendel.burrell@gmail.com]

Earlier this year, the FDA warned that it intends to bar advisers with financial associations to pharma and medical device companies > $50,000. Under the draft guidance, researchers with grants or consulting fees less than the $50,000 target would be allowed to serve in an advisory capacity to the FDA but would not be allowed to vote during the meeting. Public comments have been submitted but the agency has not issued a final ruling. It isn’t clear why the bar was set at $50,000 as the point at which a financial relationship causes a conflict of interest.

Will the FDA be able to locate thought leaders, experienced researchers without any financial association to industry? Pharma and device companies provide 100s of millions of dollars to academic institutions and hospitals for the execution of clinical research. The FDA believes that it should be able to grant waivers so that the nation’s best and brightest and most experienced medical scientists can continue to participate on advisory panels.

Many clinical researchers, some with academic affiliations, serve as consultants for early stage companies. Companies need the guidance in order to develop clinical protocols, to provide historical perspective on a disease, and to characterize the need or unmet medical need. As noted in the Globe article, several Nobel laureates would have limits imposed on their participation in FDA advisory panels.

http://www.boston.com/business/globe/articles/2007/08/07/bill_calls_for_fda_to_end_all_conflicts_of_interest/