FDA Policy/General

More Conflict of Interest Transparency Needed: GAO

The Government Accountability Office (GAO) says FDA should publicly share information on how it determines whether advisory committee members have conflicts of interest. A GAO report says the agency does not make this information available currently because it has not finalized a required guidance on the matter more than 13 years after a law required such a guidance. GAO says FDA also has not posted on its Website how it makes such decisions in the interim.

Further, the report says, FDA does not publicly share how it determines whether guest speakers who are invited to make scientific presentations to advisory committees have financial conflicts or appearance issues and whether they should participate in meetings. “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,” GAO says.

The report says that between 6/2018 and 5/2025, FDA invited an average of about 29 committee members to each of the 17 most recent meetings for committees that

discuss opioids. Across those meetings, it says, the agency’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, the report says, 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,” the report says.

GAO says it recommends that FDA:

establish a time frame for issuing and publicly sharing the required financial conflict of interest guidance;
make public how it determines conflicts for committee members in the interim; and
make public how it determines conflicts and appearance issues for guest speakers.

FDA concurred with the recommendations, the report says.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome