FDA Hasn’t Finalized Conflict of Interest Rules for 13 Years: Watchdog

Health officials say they’re working on the conflict-of-interest rules.

The U.S. Food and Drug Administration in White Oak, Md., on June 5, 2023. Madalina Vasiliu/The Epoch Times

Food and Drug Administration (FDA) officials have not finalized conflict-of-interest rules despite more than 13 years having passed since a law was enacted requiring them to do so, according to a new report.

The Government Accountability Office (GAO) stated in the March 24 report that the lack of finalized rules and the FDA not sharing how it determines financial conflicts of interest for members of its advisory committees is harming transparency.

The FDA’s website had information on steps it took to analyze possible conflicts of interest for advisers, but that information was withdrawn in 2019, the GAO found. FDA officials said they withdrew the information because they planned to update it to comply with changes to the law and policy, but they have not yet posted updated information.

“The guidance development process has continued for many years without a clear time frame for issuing or publicly sharing the guidance,” the office stated in the report. “It has been over 6 years since the previous 2008 guidance was withdrawn, and over 13 years since the law requiring FDA to issue the guidance was enacted. Without establishing time frames, it is unclear when FDA will issue or publicly share the guidance, or how much longer the process might take.”

It stated that, without making public how the agency determines conflicts of interest, “FDA leaves the public without knowledge of how the agency makes these determinations, including whether the agency is making them in a reasonable and consistent manner.”

Between June 2018 and October 2024, there were 123 recusals from advisory committee members across 107 meetings, the watchdog found. The FDA also granted 51 waivers to members who had conflicts of interest. Waivers are granted when officials determine that the need for a member’s service outweighs the conflict of interest.

Advisory committee members with financial interests were more likely to vote in favor of companies seeking approval, according to a 2014 study.

The GAO recommended that the FDA establish a time frame for finalizing guidance on how it determines conflicts of interest.

The Department of Health and Human Services, the FDA’s parent agency, agreed with the recommendation.

“FDA will issue guidance on how it determines conflicts of interest for FDA advisory committee members and will post this guidance on the agency’s advisory committee program website,” a department official, Gary Andres, said in a letter to the GAO.

No timeline was provided for rectifying the problem, but Andres said that in the interim, the FDA would be publicly posting and updating major milestones that are required for the update. The department also stated that it will share details on how it evaluates whether guest speakers, who may speak for an organization or company, have conflicts of interest.