FDA’s About-Face on Financial Conflicts of Interest

Last July, as part of a Public Citizen series featuring speakers who head regulatory agencies, Food and Drug Administration (FDA) Commissioner Margaret Hamburg gave a talk here and drifted onto the issue of allowing more financial conflicts of interest — financial ties to drug or device companies — for members of FDA advisory committees. Complaining that 2008 rules limiting such conflicts might have to be loosened due to the difficulty in finding qualified scientific experts without such ties, Hamburg stated, “We have to be sure that FDA has subject-matter experts that we need for our important decision making.”

According to Bloomberg News, Hamburg was echoing the views of Rep. Fred Upton of Michigan, chairman of the House Energy and Commerce Committee, who had stated that the conflict-of-interest rules are slowing new product approvals because advisory committees lack sufficient qualified members. Since Hamburg’s statement, legislation to allow the FDA to significantly loosen the limits on such financial conflicts was introduced in both the House and the Senate with the support of the drug and device industries. “Our view is there is a need to improve the process of the advisory committees, particularly in areas where there is a paucity of experts,” Pfizer’s Geno Germano told a House committee.

One serious problem undermines the validity of the “paucity of experts” claim and suggests that Hamburg was more informed about industry views than the actual FDA facts. (Full disclosure: I am on the FDA’s Drug Safety and Risk Management Advisory Committee, and probably to the chagrin of the industry, I have no financial conflicts.)

The problem is that the evidence for a paucity of qualified scientists without financial conflicts is mainly nonexistent: First, the FDA website has documented a steady decrease in the number of vacancies on FDA advisory committees for the past two years, even with the more patient-friendly, anti-conflict 2008 rules in effect. Second, the need to grant a waiver allowing a financially conflicted advisory committee member participation in a specific meeting, because of “needed” expertise, has remained quite low, actually below the allowable waiver targets specified in the 2008 rule.

Dr. Hamburg’s statement at Public Citizen was uninformed and wrong, but it obviously helped to encourage strong industry efforts, supported by its indentured friends in the Congress, to weaken these important rules. She belatedly recanted 6 1/2 months later in a February testimony before a House committee. According to Pharmalot’s Ed Silverman, Hamburg said,“At the present time, we are not bumping up against our cap in terms of waivers. … We don’t, at the moment, see major areas where a legislative fix is required.” As Silverman points out, there would have been no need to backtrack if Hamburg would have looked at the FDA’s data first. We agree.