The FDA tightened regulations on financial conflicts of interest among committee members, and will increase public disclosure in several areas.
FDA advisory committee members – independent, outside experts – will not be allowed to participate in a meeting if they have a financial conflict of interest exceeding $50,000. Committee members advise agency officials on regulatory decisions involving complex medical and scientific issues. If, for instance, a committee member has received grants or holds stocks or contracts valued over $50,000, that member will not be allowed to weigh in on issues potentially related to their personal holdings.
For members with financial interests under $50,000, a waiver can be issued by FDA, but only when the member is needed to provide “essential expertise,” according to Jill Hartzler Warner, senior policy advisory and counselor, FDA, in a press briefing. The number of waivers, by law, must decrease by 5% each year, beginning with 2008, according to an FDA document. The $50,000 cap pertains to personal financial interest, and does not consider employment or affiliation with a university, for example, notes Hartzler Warner.
Other changes presented in the four new advisory committee guideline documents concern voting, the disclosure of briefing materials to the public, and an improved website, among other things. Previously, committee voting was done out loud in sequential order. Voting henceforth would be conducted simultaneously, to avoid influence and “voting momentum,” according to the FDA documents. Individual votes will also be made public on the FDA's website.
Public disclosure of briefing materials will be made available online at least 48 hours prior to a meeting. Most of the recommended changes are effective immediately, with others expected to be implemented within 120 days.
In the press briefing, Randall Lutter, PhD, deputy commissioner for policy, FDA, said of the changes, “These policies go well beyond the legal requirements enacted recently in Congress.”