New FDA head says no more pharma on advisory committees

In a news release issued yesterday, the FDA has announced a new policy directive to remove pharma industry representatives from advisory committees except where required by statute.

While it sends some signals about the priorities of new FDA Commissioner Dr Martin Makary, the actual impact of the directive is likely to be muted: most of the industry members on advisory committees are required by statute - the FDA Modernization Act of 1997 requires one on each advisory panel - and those members are already non-voting.

“While the FDA should be partnering with industry to ensure a user-friendly review process, the scientific evaluation of new products should be independent,” Makary said in a statement. “Industry employees are welcome to attend FDA advisory committee meetings, along with the rest of the American public, but having industry employees serve as official members of FDA advisory committee members represents a cozy relationship that is concerning to many Americans. In fact, the FDA has a history of being influenced unduly by corporate interests.”

The directive does not preclude industry members from attending or presenting views at meetings, but they must sit in the audience, rather than on the panel. It also allows for exceptions in situations where the necessary scientific expertise is not otherwise available.

“Public trust in the healthcare-industrial complex is at an all-time low. We need to restore impeccable integrity to the process and avoid potential conflicts of interest,” Makary said.

So far, neither PhRMA nor BIO, the two major industry groups representing the pharmaceutical industry in the United States, has released a statement about the directive.

Former commissioner Robert Califf told STAT “It’s OK with me. It’s not what I would do,” noting that the advisory committees are just that, and the FDA makes final decisions.