Study: Patient, consumer reps at FDA adcomms increasingly hold ties to pharma-backed advocacy groups
More than a third of US Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) drug advisory committee meetings held between 2013 and 2022 included a patient or consumer representative belonging to an advocacy organization that received industry funding, according to the results of a recent analysis published in Health Affairs Scholar.
At some advisory committee meetings, more than half of patient and consumer representatives who attended had connections to organizations with these active ties to industry, Genevieve P. Kanter and Toni Mankowitz, of the Leonard D. Schaeffer Institute for Health Policy and Economics at the University of Southern California, Los Angeles, wrote in their study.
The study comes as FDA has recently called for more subject matter experts and consumer representatives to volunteer for advisory committee meetings (RELATED: FDA call for new adcomm members signals renewed interest in outside advisors, Regulatory Focus 30 September 2026).
“The FDA has well-established conflict-of-interest (COI) policies for its scientific advisory committee members, focusing on members’ direct financial ties to industry—but it has paid considerably less attention to potential conflicts affecting patient and consumer representatives,” Kanter told Focus in an interview. “Among non-scientific members, indirect ties to industry—especially through affiliations with advocacy organizations that receive industry funding—are a particular concern.”
Kanter and Mankowitz evaluated 98 patient representatives and 39 consumer representatives who attended 234 CDER advisory committee meetings where voting occurred between 2013 and 2022.
The researchers looked at the organizational activities of representatives not reported to FDA who belonged to patient advocacy organizations, patient support groups, patient informational groups, and medical research foundations. They also characterized the affiliation these representatives had within the advocacy organizations, such as whether they held a board member, leadership, or executive role.
Using organization annual reports and websites, the researchers tracked known pharmaceutical companies that donated to these affiliated organizations in the year the patient or consumer representative attended the advisory committee meeting.
Their analysis found that, on average, at least one patient representative and one consumer representative were present at each meeting, with patient representatives affiliated with a median of one advocacy organization. Overall, 58.8% of patient representatives and 48.7% of consumer representatives were affiliated with an advocacy organization, and among those with affiliations, 50.9% of patient representatives and 73.7% of consumer representatives held an executive or leadership role in the group.
Over the decade of data, Kanter and Mankowitz found that 38.0% of advisory committee meetings included a patient or consumer representative from an organization that had received funds from a pharmaceutical company that same year, with patient representatives at 25.8% of meetings and consumer representatives at 17.4%. The researchers also found 10.7% of CDER drug advisory committee meetings contained a patient or consumer representative to an advocacy organization that received industry funding from a sponsor of the product being discussed in the meeting.
Research published in 2016 on the same topic found 9% of patient or consumer representatives appearing at advisory committee meetings between 2009 and 2012 belonged to advocacy organizations with active industry ties, suggesting an uptick in the percentage of patient and consumer representatives with these potential conflicts, the researchers said. However, Kanter and Mankowitz acknowledged they included a broader range of organizations in their analysis compared to the prior study.
Kanter told Focus that other research has also shown that a majority of patient advocacy organizations and patient organizations receive donations from pharmaceutical, biotechnology, and medical device companies.
“Our findings show that patient and consumer representatives with industry ties through advocacy organizations frequently attend and vote in FDA advisory committee meetings,” she said.
She noted that the results show a gap in FDA’s COI policy that “could be a source of undue industry influence on these committees.”
“Some FDA watchers have pointed out that consumer reps appear to be more like patient reps or industry reps, rather than representatives of consumer interests,” Kanter said. “Our study suggests that there is some truth to that critique.”
Increased scrutiny for advocacy organizations
Reshma Ramachandran, assistant professor at Yale School of Medicine, and co-director of the Yale Collaboration for Regulatory Rigor, Integrity, and Transparency, who was not involved with the study, told Focus she was surprised by the finding that nearly 11% of patient or consumer representatives belonged to an organization that received funding from the sponsor of a product under review at the advisory committee meeting.
Ramachandran said the results point to the need for FDA to apply greater scrutiny in how it selects patient and consumer representatives for its advisory committees. A lot of attention has been focused on conflicts of interest for advisory committee members, but “not so much the patient and consumer advocacy organizations,” she said.
Patient and consumer representatives tend to hold particular sway over discussions at advisory committee meetings, especially when the science is ambiguous, and there are unanswered questions about efficacy, Ramachandran added.
“I think that’s even more reason for the agency to take the findings of the study seriously, and also to look critically in terms of who are they putting on these committees as patient representatives and consumer representatives, given how much weight their words have in the discussions and also in the voting process in particular,” she said.
More transparency needed
Kanter told Focus that she’d like to see public disclosure of Section 502 waivers, which allow advisory committee members to participate in a meeting despite potential conflicts of interest.
Other potential solutions proposed by the authors include the publication of a final guidance document on relationships with advocacy organizations, and a revision of Form 3410 that would “more explicitly address both formal COIs and appearance issues related to these ties.
Ramachandran said that a final guidance document and publication of Section 502 waivers would be welcome.
“I think in the spirit of radical transparency from the agency, they should be making those waivers publicly available,” she said.
When it comes to Form 3410, the COIs can be a little murkier. For instance, a patient representative for an advocacy organization may be unaware of the financial ties the organization has to a pharmaceutical company in a given year, Ramachandran explained.
Level of involvement with an advocacy organization is also a factor. Patient advocates may receive training sponsored by a company, but be otherwise uninvolved with the sponsor.
Other patient and consumer representatives frequently attend advisory committee meetings on behalf of an advocacy organization or serve as consultants to pharmaceutical companies.
“I think those are very clear cut in which the FDA could say those folks should not be serving on advisory committees, when they're kind of these sort of like professional patients and not necessarily real-world patients that are having true disease experience and trying to navigate treatment options,” Ramachandran said.
To obtain this level of detail on patient and consumer representative connections to industry, “I think it would require FDA to interrogate more the patient representative’s involvement with an organization and the organization itself,” she said.
Ramachandran suggested FDA could potentially use the Centers for Medicare & Medicaid Services OpenPayments database to identify conflicts of interest for patient and consumer representatives and their advocacy organizations. Through an act of Congress, companies could be required to provide a list of all the patient advocacy organizations or consumer advocacy organizations they allocate funds to and include it in the database.
“That would be an incredible resource for FDA that would allow them to do better enforcement and also more efficiently [vet] patient and consumer representatives to make sure that there isn't an inadvertent conflict of interest that they might have missed that's not been self-reported,” she said.
