The Food and Drug Administration (FDA) announced that it is removing representatives of pharmaceutical companies from its advisory committees. The development serves Department of Health and Human Services Secretary Robert F. Kennedy Jr.’s promise to “carry out the Department’s work with ‘radical transparency’ and mitigate perceived industry influence and conflicts of interests,” the FDA said in a news release.
“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 FDA Commissioner Martin A. 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. We need to restore impeccable integrity to the process and avoid potential conflicts of interest,” Makary added.
The directive does not prohibit the representatives from attending meetings or presenting their views when appropriate. Pharmaceutical company employees may serve as committee members “when required by statute,” the FDA said. “Also, exceptions can be made in rare circumstances (i.e., when the scientific expertise in an area is only available from an employee of an FDA-regulated company) provided that the official strictly complies with the applicable ethics requirements.”
Makary shared the policy with former Fox News host Megyn Kelly, saying that the FDA is putting an end to the representatives’ presence on committees “where we can by statute, and we’re replacing them with patients and family caregivers.”
“There should not be a cozy relationship,” he explained.
