Employees of companies regulated by the FDA—such as pharmas or biotechs—are no longer allowed to serve as members of FDA advisory committees, according to a new directive from the agency's commissioner, Marty Makary, M.D.
The directive is designed to mitigate perceived industry influence and aligns with the HHS secretary Robert F. Kennedy Jr.’s vision of “radical transparency,” according to an April 17 release.
Instead, the FDA will prioritize the role of patients and caregivers on the committees, which are made up of independent experts who provide recommendations on scientific, technical and policy decisions. Advisory committees often consist of individuals with specialized knowledge and do not have formal decision-making power.
“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 the release. “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 committees represents a cozy relationship that is concerning to many Americans."
Makary cited the FDA's “history of being influenced unduly by corporate interests,” though an HHS spokesperson did not respond to Fierce Pharma's request for specific examples.
“Public trust in the healthcare-industrial complex is at an all-time low,” Makary added. “We need to restore impeccable integrity to the process and avoid potential conflicts of interest.”
Exceptions can be made in unique circumstances, such as one where specific scientific expertise is only available from an employee of an FDA-regulated company, according to the agency.
Staffers at regulated companies are still permitted to present their views at advisory committee meetings and can serve as representative members when required by statute.
The new directive comes amid a flurry of other changes, as President Donald Trump’s administration restructures federal agencies in efforts to save money and improve efficiency. Other changes from Makary include a shift away from animal model requirements for investigational new drug (IND) applications for new monoclonal antibodies, with an increased focus on computational models and human cell lines and organoids.