The Food and Drug Administration is proposing to beef up its conflict-of-interest guidelines for experts who serve on its advisory committees, the agency announced in a teleconference.
Proposed guidelines would bar experts with stock or other financial interests worth more than $50,000 in a particular company from reviewing that manufacturer's product, and ban voting by those who receive or own less than $50,000.
The $50,000 rule would be applied to any holdings or interest within 12 months of an advisory panel meeting.
The proposal was billed by FDA officials as an upgrade of guidelines that have been in effect since 2000 and were made partly in response to public demands for more accountability, according to Randall Lutter, FDA acting deputy commissioner for policy.
“[The] FDA is committed to making the advisory committee process more rigorous and transparent so that the public has confidence in the integrity of the recommendations made by its advisory committees,” said Mr. Lutter in a statement issued by the agency.
However, in the briefing, he said the FDA “was not aware of any instances where decision making has been adversely affected by conflicts members might have.”
The new guidance attempts to balance the quest for transparency with the need for qualified experts, said Mr. Lutter.
As in the past, the guidelines are not legally binding. They are offered as suggestions to staff evaluating potential conflicts of interest by both government and nongovernment employees. It is rare for staff to make decisions that fall outside of the guidance, though, and waivers will likely only rarely be granted, said Mr. Lutter.
For instance, if a panel member has received an individual grant or other fee of less than $50,000 from a company for work in the hematology area, but is reviewing the company's cardiology drug or device, that person might be allowed to participate in the panel meeting.
The guidance document was posted on the FDA's Web site on March 21.