Industry representatives will still be allowed at these meetings, but they will no longer have a spot on the advisory committee.
The FDA will limit pharmaceutical company employees from serving as members on its independent advisory committees, the agency announced on Thursday.
Commissioner Marty Makary in a statement said that the move will help “restore impeccable integrity” to the drug review process and minimize or eliminate “potential conflicts of interest at the agency.” As per the FDA’s new policy, advisory committees should prioritize input from patients, caregivers and other community representatives.
Pharma representatives are still “welcome” at these meetings, according to Makary, who conceded that the agency “should be partnering with industry to ensure a user-friendly review process.” However, having company employees on the committees could foster a “cozy relationship” between the advisors and the industry, which could be “concerning to many Americans.”
As it is, Makary claimed, without evidence, that the public’s trust in the FDA and the healthcare system “is at an all-time low,” a sentiment that he blames on the agency’s “history of being influenced unduly by corporate interests.”
There will also be exceptions “in rare circumstances,” particularly when “expertise in an area is only available from an employee of an FDA-regulated company,” according to Thursday’s announcement. In those cases, pharmaceutical employees will adhere to a set of ethical guidelines.
The FDA’s advisory committees are composed of external experts who discuss and provide independent feedback regarding a variety of subjects. Often, these panels are convened to evaluate products that are being reviewed, looking at clinical data to make a recommendation—whether to approve the drug or not—to the FDA. Crucially, these votes are non-binding: The FDA is not required to follow the committees’ advice, though it often does.
Several laws govern the conduct and composition of these advisory committees to ensure that the panelists can deliver rigorous recommendations and to eliminate potential conflicts of interest, as per the FDA’s own website.
One such law, the FDA Modernization Act, passed in 1997, requires the agency to “include representatives from the biologics and/or drug manufacturing industries.” These industry representatives, however, do not have a vote and cannot be from the drug sponsor seeking a review.
FDA advisory committees typically already include a consumer representative. According to the agency’s website, the consumer representative will not only represent the community’s voice in the committee but will also “serve as a liaison between the committee and interested consumers, associations, coalitions, and consumer organizations.”
It is yet unclear how the new FDA policy will change the current composition of its advisory committees, or how it will square with the requirements of the FDA Modernization Act.
