Congress told the Food and Drug Administration (FDA) 13 years ago that it must develop and make public regulations to prevent members with conflicts of interest from serving on the agency’s influential advisory boards and to be transparent about how those regulations are administered.

Now, the Government Accountability Office (GAO) wants to know why the FDA has failed to do so for so long, and the investigative arm of Congress also wants the powerful drug agency to produce a plan for promptly meeting its transparency obligations on conflicts-of-interest regulations and administration.

The GAO report was requested by Senate Appropriations Committee Chairman John Hoeven (R-N.D.), who is chairman of the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Subcommittee. In a 2025 appropriations bill report, Hoeven’s subcommittee said it was “concerned with panels that the FDA recently deployed to evaluate scientific matters related to talc, infant formula, and cell and gene therapies that could impact public health.”

The report continued, “The FDA should assess scientific issues in a transparent manner and must adhere to principles established by Congress in the Federal Advisory Committee Act. The subcommittee is concerned that the agency did not allow public participation or provide for public comments, and panelists did not disclose potential conflicts of interest. The FDA must follow long-standing practices that ensure processes and decision-making are transparent, unbiased, and grounded in science. The subcommittee expects that any future engagement with regards to these and other topics will be based on sound science and free from conflicts of interest.”

The FDA has 30 advisory panels made up of experts in a variety of fields to provide assessments and recommendations for and against proposed new drugs, treatment products, and related procedures. Those assessments can be crucial in determining whether a manufacturer gets FDA approval to market a new drug or medical product. Hundreds of millions of dollars in sales revenue and multitudes of jobs in the health care industry can be won or lost.

In its assessment of the FDA’s actions, the March 24 GAO report described the problem in stark terms.

“The FDA uses a combination of government-wide requirements and internal policies to guide its conflict-of-interest review process. However, FDA does not publicly share information on how it determines whether members have financial conflicts of interest and whether they should participate in committee meetings. This is because FDA has not yet finalized required guidance on the matter more than 13 years after a law required it,” the report said.

“In addition, FDA has not posted to its website how it makes these decisions in the interim. Further, the agency does not publicly share how it determines whether guest speakers have financial conflicts or appearance issues and whether they should participate in [advisory panel] meetings,” the report continued.

“Publicly sharing information on how FDA makes these determinations would be consistent with the law and FDA’s own best practices. Making this information public would increase transparency and provide the public with greater assurance that FDA has steps in place to manage conflicts of interest for advisory committees, and, therefore, help to ensure accountability and consistency in decision making,” the report added.

In its report, GAO assessed 107 meetings of 17 FDA advisory panel meetings convened between June 2018 and September 30, 2024, and found that 2,566 panel members participated. Of those, only 123 members, or 4.9% of the total participating, were recused. In addition, 51 members received waivers that allowed them to participate despite potential conflicts of interest, usually because they possessed vitally important and unique expertise.

Advisory panel members typically serve terms that can stretch as long as four years. They can only be removed by the secretary of the Department of Health and Human Services (HHS) or the FDA commissioner. The FDA also sometimes appoints temporary panel members who have unique expertise that is applicable in a particular case. Nominations for panel members are sought through announcements in the Federal Register.

In response to GAO, Gary Andres, HHS’s assistant secretary for Legislation, said the 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 website.” Andres did not provide a timetable or deadline for completing that promised issuance.

The GAO report on FDA’s lack of transparency regarding its policing of potential conflicts of interest in the advisory committees came only a few days after Senator Rick Scott (R-Fla.) asked HHS Secretary Robert Kennedy, National Institutes of Health (NIH) Director Jay Bhattacharya, and FDA Commissioner Martin Makary to redouble their efforts to prevent the Chinese Communist Party (CCP) from continuing its lengthy and often successful commercial espionage, especially in the medical research field.

“Federal law enforcement agencies have repeatedly documented Chinese state-sponsored trade secret theft and economic espionage, including in the biomedical sector. National Institutes of Health (NIH)-funded researchers have faced prosecution for failing to disclose foreign affiliations, and federal agencies have taken steps in recent years to strengthen disclosure and transparency requirements. Despite these efforts, it remains unclear whether national security risks are being consistently and rigorously evaluated in connection with [Investigational New Drugs] IND approvals, expedited designations, and clinical trial authorizations involving entities linked to foreign adversaries,” Scott told the three federal health officials in a March 19 letter.

“As the world’s largest public funder of biomedical research, the NIH has a responsibility to safeguard taxpayer-funded innovation. As the federal regulator responsible for approving and overseeing clinical trials and therapeutics, the [FDA] must ensure that safety, efficacy, and national security considerations are fully integrated into its decision-making. The [HHS] plays a central role in coordinating these responsibilities,” the Florida lawmaker wrote.

Potential conflicts of interest within the FDA and other federal health care agencies like the Centers for Disease Control and Prevention have been an issue for years. In a November 2023 article in the British Medical Journal (BMJ), for example, Senior Editor Peter Doshi reported that “in a 2016 study published in The BMJ, researchers followed the trajectories of 55 medical reviewers involved in drug approvals in FDA’s haematology-oncology division over several years. Of 26 officers who left the FDA, 15 later worked or consulted for industry. A separate investigation by Science magazine in 2018 similarly reported that ‘11 of 16 FDA medical examiners who worked on 28 drug approvals and then left the agency for new jobs are now employed by or consult for the companies they recently regulated. This can create at least the appearance of conflicts of interest.’”