The FDA is proposing new guidelines that exclude experts from panels that authorize new drugs and products because of intellectual conflicts of interest. Jeanne Lenzer reports
The US Food and Drug Administration has a longstanding policy on financial conflicts of interest for members of advisory committees involved in authorizing new drugs or medical products. But this year, for the first time, the agency is establishing guidelines regarding “appearance issues,” which include identification of intellectual conflicts.1 In a draft guidance issued in June and open for public consultation until 26 November, the FDA describes the characteristics of advisory committee members and situations that could create the appearance of a conflict or the perception that a committee member “lacks impartiality.”123
In a brief section of the proposed new guidance, much of which focuses on financial conflicts of interest, the agency cites federal regulations indicating that individuals may be excluded from voting or even participating in hearings on new products if their “impartiality is likely to be questioned” by a “reasonable” person.
This concept, say critics, is ill defined and ill conceived; furthermore, the FDA has already used it in a biased manner that protects commercial interests over the public interest.
A brief history of FDA recusals
The FDA has been long under fire for excluding certain advisory committee members from participating or voting in hearings on new drugs or products because of what it claims are “intellectual conflicts of interest.”
On 20 February 2009, Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, acknowledged that a “mistake was made” during a highly publicized incident in which an expert was recused for an alleged “intellectual conflict.” Eli Lilly, manufacturer of prasugrel, had called the FDA four days before an advisory panel was to review the drug.
FDA issues new draft guidelines for ‘appearance’ of conflicts of interest https://www.statnews.com/pharmalot/2016/06/29/fda-conflicts-interest-guidelines/ via @statnews