By NED FEDER
Can a drug or device company use hidden payments to members of FDA advisory committees to ensure that that member will provide favorable advice to the FDA about their product?
Undoubtedly this has happened, though it's hard to prove. Advisory committee members are supposed to comply with the FDA’s conflict-of-interest rules, which set limits on the financial arrangements that committee members make with the medical industry.
But the conflict-of-interest rules may be about to weaken.
Speaking to Public Citizen, a watchdog group, FDA Commissioner Margaret Hamburg said on Monday that the current conflict-of interest rules “may loosen next year.” (See coverage here, here, and here.) If the rules on the financial arrangements of advisory committee members are made more permissive, this will obviously enlarge the pool of experts from which the FDA can choose and thus allow the FDA to recruit committee members more easily. That's one of the arguments for weakening the rules.
On the other hand, the dangers of tainted advice from advisory committee members who are biased (or bought) by a financial conflict of interest are well known.
POGO is not using the present blog post to take a stand on the issue of tighter versus looser rules on conflicts of interest. However, we do want to champion a related change. We believe that many of the private financial arrangements made by advisory committee members should be subject to full public disclosure.
Currently, each prospective member of an FDA advisory committee must send the FDA a Confidential Financial Disclosure Report (CFD report) on Form FDA 3410. For a few members of the advisory committee, some of that information may be made public (for example, if there’s a waiver for that member). With this unusual exception, however, the information on the CFD report of all advisory committee members remains strictly confidential, sealed within the files of the FDA.
We recommend that the FDA make it a practice of publicly releasing each committee member’s CFD report, suitably redacted if necessary. (Of course, the member's permission would be needed in advance and as a condition for joining the committee.) Without these disclosures, we are forced to trust FDA officials, who've been wrong in the past, to make the right decision, privately, on the sensitive issue of advisory committee membership. Clearly the public interest will be better served in this case, as in many others, by full disclosure.
If Commissioner Hamburg goes through with her plans to weaken the current conflict-of-interest rules, the full disclosure of financial arrangements will become all the more important.
For more about the value of disclosing CFD reports, see POGO's August 2010 public comment.
Dr. Ned Feder is POGO's Staff Scientist.