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.”
