GAO calls on FDA to finalize guidance on adcomm COI

The US Government Accountability Office (GAO) says that the US Food and Drug Administration (FDA) should issue a timeline for finalizing a guidance on handling potential financial conflicts of interest for members of its advisory committees. The agency said the move would provide the public with greater transparency and assurance that it is taking significant mitigating steps to prevent conflicts of interest in regulatory decision-making.

On 24 March, GAO published a report on how the FDA manages potential financial conflicts of interest that may affect members of its more than 30 advisory committees. The committees consist of external subject-matter experts who advise the regulatory agency on matters ranging from whether to approve specific products to how to address significant regulatory matters.

The issue has been a major concern for Health and Human Services Secretary Robert Kennedy Jr., who has repeatedly stated that advisory committees have had serious conflicts of interest due to members' past relationships with the pharmaceutical industry. Over the past year, he has fired federal advisory committee members, most notably those on vaccine-related committees at FDA and the Centers for Disease Control and Prevention (CDC) and replaced them with new members.

When investigating FDA's advisory committees, GAO specifically reviewed two committees that advise on opioids and found that between June 2018 and May 2025, the agency invited 29 members to participate in each of the 17 most recent committee meetings on average. It noted that committee members were recused 15 times during that period, and the regulatory agency granted a waiver once to allow a member with a conflict of interest to participate because their expertise outweighed their financial interest.

GAO noted that the Federal Food, Drug, and Cosmetic (FD&C) Act requires FDA to issue guidance detailing how it reviews financial interests of committee members that are disclosed to the agency but do not meet the definition of a disqualifying interest under regulations. However, GAO notes that FDA has yet to draft guidance on the topic.

“FDA has worked to build public trust in its advisory committees by posting information on its website about its policies, including how the agency addresses situations when advisory committee members may appear to lack impartiality,” said GAO. “In addition, the agency makes public certain results of its conflict of interest review process by posting meeting agendas, transcripts, and information on financial waivers to its website, as shown by our review of advisory committee meetings related to opioids.

“However, FDA does not make public how it determines whether advisory committee members have financial conflicts of interest or whether members with conflicts should participate in committee meetings,” the agency added. “This is because FDA has yet to finalize the required guidance and has not established a time frame for doing so.”

After reviewing FDA's conflict of interest management process, GAO said the regulatory agency should provide a timeline for when it plans to issue final guidance on the topic. It also said the regulatory agency should detail on its advisory committee website how it determines whether advisory committee members have financial conflicts of interest and whether those members should still be allowed to participate in committee meetings. Additionally, it said the website should include a guidance document explaining how the regulatory agency decides whether advisory committee guest speakers have financial conflicts of interest and how it determines whether they should still be allowed to participate.

“Posting information on how FDA determines conflicts of interest and appearance issues, for example in the form of guidance documents, to the agency’s advisory committee program website would help the agency increase transparency, consistent with statements by the FDA Commissioner,” said GAO. “It could also provide greater assurance to the public that FDA has steps in place to manage conflicts of interest and to mitigate perceived industry influence on FDA’s decisions.”

The agency noted that it had shared its findings with the Department of Health and Human Services (HHS), which generally agreed with its findings.

GAO report

GAO calls on FDA to finalize guidance on adcomm COI

Related topics

Recommended content

Welcome to the new RAPS Digital Experience