Conflicts of interest at the FDA go further than pharma financial ties to agency staff and experts. At advisory committee meetings, where panels debate a drug’s potential approval, testimony from the public could also be skewed by conflicts.
A recent analysis found that 43% of 1,481 testimonies at adcomm meetings over a nine-year period came from speakers who disclosed a conflict of interest. And because the FDA only encourages conflict disclosures but doesn’t require them, the actual number could have been higher, according to the Mass General Brigham researchers.
Any financial support from a pharma company could be considered a conflict of interest, including fees for consulting or running independent trials. Reimbursement for travel and lodging accounted for more than a third of reported conflicts in a different study examining 10 years of testimonials at psychopharmacologic drug adcomms meetings.
While speakers at adcomms run the gamut from clinicians to public health advocates, almost half evaluated in the Mass General Brigham research were patients and caregivers. Although the study wasn’t designed to measure the impact of those testimonies on agency decisions, 82% overall supported an FDA nod, with speakers who reported a conflict 11% more likely to vouch for the drug.
“The voices of patients and advocates are vital, but to ensure more balanced input, the FDA should seek contributions from a broader range of perspectives,” lead author Leah Rand, a pharmacoepidemiology and pharmacoeconomics research scientist at Mass General Brigham, said in a statement about the study’s results last month.
FDA takes aim at advisory oversight
The FDA has prioritized tackling conflicts that have long been criticized, recently taking aim at the outside scientists serving on adcomms.
As part of its “radical transparency” push, the FDA in April began limiting pharma employees from becoming adcomm members or attending their meetings, except for rare circumstances when specific scientific expertise is scarce.
The agency has also hailed efforts addressing conflicts of interests as one of its chief achievements this year.
It’s unclear, however, if the FDA’s recent moves will make a meaningful dent in the challenge.
Company reps on adcomms are already non-voting members who typically offer background context on the drug. The FDA’s Modernization Act has also mandated industry involvement in newly formed adcomms since it was passed in 1997.
Some estimates of conflict throughout all U.S. health agencies may have also been overblown, according to some reports.
Before HHS Secretary Robert F. Kennedy Jr. ousted 17 members of the CDC’s Advisory Committee on Immunization Practices in June, he blasted the agency for its “weak enforcement” of rules meant to monitor conflicts of interests.
“Most of ACIP’s members have received substantial funding from pharmaceutical companies, including those marketing vaccines,” he wrote in a Wall Street Journal opinion piece.
But the rate of conflicts on ACIP actually plummeted from nearly 43% in 2000 to 5% in 2024, according to analysis published in JAMA a few months later. The same trend held true on the FDA’s Vaccines and Related Biological Products Advisory Committee, where conflicts dropped from 11% to zero, the research found.
Meanwhile, old conflict concerns are giving way to new ones among the incoming members of the FDA’s and CDC’s committees under Kennedy. The CDC hasm publicly disclosed just one conflict of interest for the members appointed to ACIP this year.
At FDA adcomms, some new panelists have been accused of purporting fringe scientific ideas while failing to comply with transparency rules, such as reporting conflicts and publishing details about predispositions to the given topic, according to the Associated Press.
The FDA has yet to report additional plans to address conflicts, but the Mass General Brigham researchers had advice for how it should handle the issue among public speakers at adcomm meetings, writing that the agency “should require disclosures from public speakers and could verify these against sources such as the Open Payments (for clinicians) or organizations’ tax filings.”
