Regulations

FDA to Ban Food, Pharma Employees from Advisory Committees ‘Where Statutorily Allowed’

Banning employees of companies the FDA regulates from scientific evaluation of products will "restore impeccable integrity" and "avoid potential conflicts of interest," said Commissioner Martin Makary.

Author Image

By: Mike Montemarano

Associate Editor, Nutraceuticals World

Photo: Tada Images | Adobe Stock

Martin A. Makary, MD, MPH, Commissioner of the U.S. Food and Drug Administration (FDA) announced a new policy directive that seeks to limit individuals who are employed at companies regulated by FDA, such as pharmaceutical companies, from serving as official members of FDA advisory committees, where statutorily allowed.

The agency stated that this initiative is in line with HHS Secretary Robert F. Kennedy Jr.’s mission to carry out the department’s work with “radical transparency,” and mitigate perceived industry influence and conflicts of interest.

The agency will instead prioritize input from patients and caregivers.

The agency uses advisory committees to obtain independent expert advice and recommendations on scientific, technical, and policy decisions.

“While the FDA should be partnering with industry to ensure a user-friendly review process, the scientific evaluation of new products should be independent,” said Makary. “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.

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

Employees of regulated companies won’t be precluded from attending or presenting their views at advisory committee meetings, or from serving as representative members of the committee where required by statute. The agency noted that exceptions can be made in rare circumstances, such as when the scientific expertise in a given area is only available from an employee of an FDA-regulated company.

Keep Up With Our Content. Subscribe To Nutraceuticals World Newsletters