New FDA Guidelines Aim To Guard Against Conflicts of Interest
On Monday, FDA issued final guidelines that seek to limit conflicts of interest among advisory committee members, the San Francisco Chronicle reports.
Under the guidelines, medical experts with more than a $50,000 financial interest in companies cannot serve on advisory committees that review their products or the products of their competitors. Medical experts with less than a $50,000 financial interest can serve, provided that FDA considers their participation necessary and issues a waiver.
The guidelines also allow FDA in certain cases to prohibit participation on advisory committees by some medical experts, regardless of whether they have more than a $50,000 financial interest.
The $50,000 limit includes stock, grants and other financial interests (Tansey, San Francisco Chronicle, 8/5).
In addition, FDA will change the voting process for advisory committee members from sequential, which often can influence the votes of other members, to simultaneous. FDA will post a record of the votes of individual advisory committee members online.
FDA also will post briefing materials online 48 hours before advisory committee meetings and change the circumstances under which committees meet to address issues.
FDA officials said that the guidelines will take effect immediately and will be fully implemented within 120 days (Parnass, CQ HealthBeat, 8/4).
Randall Lutter, a deputy FDA policy commissioner, said, "It's imperative that we seek advice from independent experts and that we do so in a way that is public, open and transparent" (Bloomberg/Boston Globe, 8/4). He said, "The FDA's regulatory decisions affect the health of millions of Americans, and we don't make those decisions in a vacuum" (CQ HealthBeat, 8/4).
Jill Warner, senior policy adviser at FDA, said that agency efforts to find medical experts without conflicts of interest have proven difficult. She said, "To develop innovative products, industry relies on the same experts."
Sidney Wolfe, director of the Health Research Group at Public Citizen, praised the guidelines. He said, "The whole underlying thought is that money talks," adding, "It is at least possible, though it's not certain, that it'll affect their vote" (San Francisco Chronicle, 8/5).
In addition, Wolfe said, "Over time, the percentage of people who have these (conflicts) will diminish," adding, "A lot of it will have to do with how much energy the FDA is willing to expend to find people who don't have a conflict of interest."
Diana Zuckerman, president of the National Research Center for Women & Families, said that FDA should reduce the $50,000 limit and that she expects many medical experts with less than a $50,000 financial interest to receive waivers to serve on advisory committees. She said, "The FDA has consistently used a very low standard for granting waivers, and there is no evidence that this will change" (Freking, AP/Boston Globe, 8/4).