ROCKVILLE, Md. -- In an effort to insulate the FDA and members of its advisory panels from suspicion of conflicts of interest, the agency said it will no longer solicit counsel from researchers who have received ,000 or more from a manufacturer with a product under review.
ROCKVILLE, Md., March 22 -- In an effort to insulate the FDA and members of its advisory panels from suspicion of conflicts of interest, the agency said it will no longer solicit counsel from researchers who have received ,000 or more from a manufacturer with a product under review.
Only researchers and clinicians who have received no money at all from manufactures of a drug or device being reviewed-and no money at all from competitors-will be permitted to serve as voting members of advisory panels.
Prospective panel members who received less than ,000 from the manufacturer in the 12 months prior to an advisory panel meeting would be eligible to serve on the panel as non-voting members, said Randall Lutter, Ph.D., acting deputy commissioner for policy in the FDA's Office of Policy and Planning.
The ,000 threshold was contained in a proposed guidance document published Wednesday by the FDA.
At a press briefing Dr. Lutter said that following the required 60-day comment period, the guidance document will serve "as set of instructions" for staffers reviewing potential advisory panel members.
Dr. Lutter said that the ,000 threshold will affect a "significant fraction" of current members of advisory panels, but would not say how many would be barred from participating once the new guidance takes effect.
The guidance document used the term "generally no participation" for researchers who have received more than ,000 from a drug or device maker. Asked to clarify that term, Lutter said the FDA commissioner did have the option of waiving this restriction, but he said the likelihood of granting such a waiver would be extremely rare.
The waiver would first require senior FDA staffers to be convinced that the unique input of that researcher was essential to the panel. Even if that were the case, "by the time the rigorous review [of potential panel members] is completed there is only a short time window in which a waiver could be authorized and finalized, and the commissioner is often inaccessible on short notice."
And finally, Dr. Lutter said that FDA Commissioner Andrew C. von Eschenbach, M.D., was "committed to insuring the integrity of the process."
Moreover, Dr. Lutter said, a waiver would grant the researcher only the right to serve as a non-voting member of the panel,
The new guidance document will replace one issued in 2000. Dr. Lutter said the earlier document had no monetary threshold and relied on a more complicated, subjective process to vet potential panel members.
The guidance document is part of the FDA's ongoing response to a scathing critique in an Institute of Medicine report, The Future of Drug Safety: Promoting and Protecting the Health of the Public, issued last September. The IOM said an overhaul of the FDA was needed to restore public confidence.