Study Ties Many Patient Voices on FDA Panels to Drug-Industry-Funded Groups

The patients and consumers who sit on the Food and Drug Administration’s drug advisory committees are meant to speak for the public when experts weigh whether a medicine should reach the market. A new study finds that many of them have been tied to advocacy groups that receive money from drug companies, and that those ties were usually not disclosed.

The analysis, by Genevieve P. Kanter and Toni Mankowitz of the University of Southern California, was published in the journal Health Affairs Scholar and drew wider attention this week after STAT reported on it. The researchers reviewed 234 voting meetings held by 12 FDA drug advisory committees from 2013 through 2022, involving 98 patient representatives and 39 consumer representatives. Using meeting rosters, transcripts and public records, they counted affiliations involving leadership roles or sustained involvement with advocacy organizations, and identified those groups’ pharmaceutical donors from annual reports and websites.

They found that 38 percent of meetings included a patient or consumer representative tied to an advocacy group funded by drug companies. About 11 percent included a representative connected to an organization that had received money from the very company whose product was under review. On several committees, such ties appeared at more than half of meetings; on the panel that reviews drugs for the nervous system, consumer representatives with such ties were present at nearly 89 percent of meetings.

Disclosure was rare. Among representatives with these affiliations, about 90 percent of patient representatives and 63 percent of consumer representatives had at least one tie that went unmentioned at the meeting.

The FDA has detailed conflict-of-interest rules for the scientists and physicians who serve on its panels, but its policies for patient and consumer members are less developed, particularly when it comes to industry funding of the groups those members belong to. The authors called the pattern a broader problem warranting the agency’s attention, and recommended that the FDA finalize guidance on its relationships with advocacy groups, revise the disclosure form members complete and publicly post the waivers it grants for conflicts.

The study has limits its authors acknowledge. Its estimates are likely conservative because of gaps in public information, its data end in 2022, and it measured how common the ties were, not whether any vote was swayed by them. Patient representatives also bring something no scientist on a panel can: firsthand experience of living with the disease a drug is meant to treat, which is why the seats exist.

The findings come two weeks after the FDA announced a nationwide effort to broaden scientific expertise and consumer voices on its advisory committees. Advisory panels do not have the final say on approvals, but the agency often follows their recommendations.