Prevalence of ties to industry-funded organizations among patient and consumer representatives on FDA advisory committees

Abstract Introduction FDA advisory committees are primarily composed of scientific experts, but also include a patient representative and a consumer representative providing public perspectives. 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. Methods We analyzed the prevalence of industry funding of advocacy organizations in which patient and consumer representatives were actively involved in the year they attended FDA advisory committee meetings between 2013 and 2022. Results Between 2013 and 2022, nearly two in five (38%) FDA advisory committee meetings included either a patient or consumer representative with active ties to a pharmaceutical-funded advocacy organization. For several FDA committees, this share was greater than 50%. More than 1 in 10 (11%) advisory committee meetings included a representative affiliated with an organization receiving funds from the sponsor of the drug under review. Conclusion These prevalence rates show that these organizational relationships extend beyond isolated cases and signal a broader problem warranting FDA policy attention.