FDA Advisory Committees: Transparency on Conflicts of Interest
Summary
The GAO reported that the FDA has not finalized guidance on determining financial conflicts of interest for its advisory committee members, nor does it publicly share how these decisions are made. This lack of transparency could affect the consistency and accountability of FDA decisions regarding drug and product evaluations.
What changed
The Government Accountability Office (GAO) has identified a lack of transparency in the Food and Drug Administration's (FDA) process for managing conflicts of interest among its advisory committee members. Specifically, the FDA has not finalized required guidance on how to determine financial conflicts of interest and has not publicly disclosed the methodology used for these determinations, despite a legal requirement to do so over 13 years ago. This report, GAO-26-107877, highlights that this opacity extends to decisions regarding waivers and authorizations for members and guest speakers to participate in meetings, potentially undermining public confidence in the impartiality of FDA's decision-making.
Compliance officers and legal professionals should note that the GAO recommends the FDA finalize its guidance and publicly share its decision-making processes for managing conflicts of interest. While the report does not specify a compliance deadline, the implication is that the FDA should expedite the finalization and publication of this guidance. Failure to do so could lead to continued inconsistencies in how conflicts are managed and may invite further scrutiny. Regulated entities that interact with FDA advisory committees should be aware of these ongoing transparency issues and the potential for future policy changes.
What to do next
- Monitor FDA's finalization and publication of guidance on advisory committee conflict of interest determinations.
- Review internal policies for managing conflicts of interest for any advisory roles or interactions with government agencies.
Source document (simplified)
GAO-26-107877 Published: Mar 24, 2026. Publicly Released: Mar 24, 2026.
Fast Facts
The Food and Drug Administration relies on advisory committees for independent advice on developing and evaluating drugs and other products. If committee members have conflicts of interest—e.g., financial investments in what's being evaluated—they generally can't participate in meetings. We reviewed FDA's conflict of interest review process, and found that it hasn't finalized guidance on how to determine if a financial conflict exists. FDA also doesn't publicly share how these decisions are made. Official guidance and more transparency could help ensure FDA decisions are consistent and accountable.
Our recommendations address these issues.
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Highlights
What GAO Found
The Food and Drug Administration (FDA) relies on more than 30 advisory committees to provide expert advice on numerous scientific topics, including opioid drugs for pain. Government-wide requirements prohibit committee members from taking part in meetings that could affect their financial interest. FDA checks for conflicts of interest by reviewing a form that committee members fill out to disclose financial interests, such as investments in drug companies. Regulations also require FDA to check for issues that could give the appearance that a committee member lacks impartiality. In some situations, FDA may grant a waiver or authorize a member to take part in a meeting, such as when the need for the member’s expertise outweighs the potential conflict. FDA also has policies to similarly review financial interests and appearance issues for guest speakers, who may be invited to meetings to present scientific information.
Examples of Financial Interests
Between June 2018 and May 2025, FDA invited an average of about 29 committee members to each of the 17 most recent meetings for committees that discuss opioids. Across these meetings, FDA’s conflict of interest review process resulted in members being recused from taking part in the meetings 15 times. FDA also granted a financial conflict of interest waiver to allow a member to participate because the agency determined their expertise was needed and that their financial interest was not substantial. In addition, FDA authorized members with appearance issues to take part in meetings seven times. These results are comparable to those of other FDA committees that GAO reviewed.
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. 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 meetings. 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.
Why GAO Did This Study
Conflict of interest rules and guidelines are essential to ensure FDA receives independent, unbiased professional expertise from advisory committees to help its efforts to assure the safety and effectiveness of drugs, medical devices, and other products. Federal requirements for advisory committees emphasize the importance of public access, input, and accountability, including addressing conflicts of interest.
A Senate Appropriations Committee report includes a provision for GAO to review how FDA addresses conflicts of interest for advisory committee meetings, particularly for opioids.
This report (1) describes FDA’s advisory committee conflict of interest policies and review process, (2) describes the results of FDA’s review process for advisory committees related to opioids, and (3) examines the extent to which FDA publicly shares its conflict of interest policies for advisory committees.
GAO reviewed relevant federal laws and regulations, as well as FDA documentation on advisory committees. GAO also reviewed published research about the results of FDA’s conflict of interest review process and interviewed FDA officials and stakeholders familiar with advisory committee meetings.
Recommendations
GAO is recommending that FDA (1) establish a time frame for issuing and publicly sharing required financial conflict of interest guidance, (2) make public how it determines these conflicts for committee members in the interim, and (3) make public how it determines conflicts and appearance issues for guest speakers.
HHS concurred with the recommendations.
Recommendations for Executive Action
| Agency Affected | Recommendation | Status |
| --- | --- | --- |
| Food and Drug Administration | The Commissioner of FDA should establish a time frame for issuing and publicly sharing required guidance on how the agency determines financial conflicts of interest for advisory committee members. (Recommendation 1) | Open When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information. |
| Food and Drug Administration | The Commissioner of FDA should post to the agency's advisory committee program website information on how FDA determines whether advisory committee members have financial conflicts of interest and how FDA determines whether they should participate in committee meetings. For example, FDA could post the information it is using to make these determinations while the required guidance is being updated. (Recommendation 2) | Open When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information. |
| Food and Drug Administration | The Commissioner of FDA should post to the agency's advisory committee program website information, such as a guidance document, on how FDA determines whether advisory committee guest speakers have financial conflicts of interest and appearance issues, and how FDA determines whether they should participate in committee meetings. (Recommendation 3) | Open When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information. |
Full Report
GAO Contacts
Mary Denigan-Macauley Director Health Care deniganmacauleym@gao.gov
Media Inquiries
Sarah Kaczmarek Managing Director Office of Public Affairs media@gao.gov
Public Inquiries
Topics
Health Care Advisory committees Conflict of interests Drugs Laws and regulations Program transparency Agency evaluations Drug safety Analgesic drugs Government employees Food
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