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Nearly 40% of U.S. Food and Drug Administration (FDA) advisory committee meetings held between 2013 and 2022 included patient or consumer representatives affiliated with organizations funded by pharmaceutical companies, according to a study published this month in Health Affairs Scholar.
FDA advisory committees assess the safety and effectiveness of drugs, including vaccines, and make recommendations on whether the FDA should approve them.
Researchers Genevieve Kanter, Ph.D., and Toni Mankowitz of the University of Southern California found that 38% of the meetings included representatives of industry-funded advocacy organizations.
In 11% of meetings, representatives attended on behalf of organizations funded in part by the manufacturer whose drug the FDA was evaluating.
“These prevalence rates show that these organizational relationships extend beyond isolated cases and signal a broader problem warranting FDA policy attention,” the researchers wrote.
According to the FDA website, the agency has about 50 technical and scientific advisory committees and panels. Members include “science-oriented” professionals, including doctors, researchers, biologists, chemists, statisticians and others, selected for their expertise on a specific committee’s function and topic area.
In addition, the website states, “each committee typically includes a consumer representative and an industry representative and, based on the meeting topic, a patient representative who provides the patient or caregiver experience for a particular disease, condition, or medical product.”
According to the study, which focused only on potential conflicts of interest among consumer and patient representatives:
“Although the FDA has enacted policies to curb conflicts of interest common among its scientific members, it has paid less attention to potential conflicts arising from patient and consumer representatives who have ties to organizations financially supported by pharmaceutical companies.”
Experts question FDA policies
The study raised alarms for several medical experts.
Dr. Elizabeth Mumper told The Defender she found any FDA advisory panel ties to groups funded by pharmaceutical companies troubling.
“The pharmaceutical industry already has disproportionate influence over elected representatives through their lobbying efforts,” Mumper said. “The conflicts of interest revealed about patient representatives with ties to Pharma are deeply concerning. I worry that self-interest does indeed compromise the independence of those tasked to evaluate safety and efficacy of new drugs.”
Dr. Meryl Nass said she believes the number of meetings in which organizations received funding from manufacturers whose drugs were being evaluated are most likely higher.
“11% seems like a low number to me,” she told The Defender. “The work groups consist of federal employees and employees of health centers and medical schools. I would expect that most of the non-federal employees have directly had contracts with vaccine companies or work at institutions that have contracts with vaccine companies.”
Nass said FDA policies can lend themselves to corruption.
“FDA surprisingly allows its employees to move directly into industry, and then, when working in industry, they can even come and lobby or converse with their former colleagues at FDA,” she said.
The FDA defended its policies, stating that the agency employs stringent rules within and outside advisory settings.
In a statement to The Defender, the FDA wrote:
“The FDA takes conflict-of-interest screening seriously and applies rigorous standards to all advisory committee appointments. All advisory committee members who are subject to federal ethics requirements, including consumer and patient representatives, are required to disclose detailed financial information, including holdings, employment, and research funding, which the FDA reviews carefully to identify and address potential conflicts before any committee deliberation.”
Previous studies documented similar conflicts
The findings add to earlier research examining pharmaceutical industry influence over patient advocacy organizations.
A 2020 systematic review published in The BMJ examined 26 studies and found that between 20% and 83% of patient organizations received industry funding. Among funded organizations, only 27% disclosed the support on their websites in the studies examining disclosure.
“Transparency about corporate funding is also inadequate,” the researchers concluded.
One prominent example involved the American Pain Foundation, a patient advocacy organization that received approximately 90% of its funding from pharmaceutical and medical device companies in 2010, a ProPublica investigation found.
According to a systematic review documenting the case, the organization promoted positions favorable to opioid manufacturers, including challenging concerns about opioid risks. ProPublica reported that the foundation closed in 2012 amid scrutiny of its industry relationships.
A 2017 study published in JAMA Internal Medicine found organizations funded by opioid manufacturers were significantly more likely to oppose the Centers for Disease Control and Prevention’s proposed opioid prescribing guidelines than groups without pharmaceutical industry funding, and none disclosed those financial ties in their public comments.
Financial conflicts have also surfaced among voting FDA advisers. A 2024 KFF Health News investigation found that 10 of 14 voting committee members reviewing Abbott Laboratories’ TriClip heart valve device had financial ties to the manufacturer totaling approximately $650,000.
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FDA ‘continually evaluates its screening processes’
The FDA requires patient representatives serving as special government employees to undergo financial conflict-of-interest screening.
According to the FDA’s Patient Representative Program, representatives provide patient perspectives during drug evaluations and must comply with federal ethics requirements.
The FDA added in a statement to The Defender:
“The FDA continually evaluates its screening processes to ensure they are thorough, consistent, and appropriate to the complexity of the issues before each committee.
“The FDA’s goal is to assemble committees with the expertise needed to provide high-quality advice while identifying and appropriately addressing potential conflicts-of-interest.”
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- FDA Approves Merck Pneumococcal Vaccine for ‘At-Risk’ Kids as Young as 2
- FDA Reviewed Autopsies of Children Who Died After COVID Vaccines, Reduced Number From 10 to 7
- Merck Deliberately Hid Gardasil Link to Autoimmune Disorders, Says Former FDA Consultant
