Bioethics Blogs

FDA Advisory Committees and Industry-Funded Patient Advocacy

Cross-posted on Objective Intent and Notice & Comment.

Industry funding of patient advocacy organizations recently has received attention from media and researchers.  For example, one 2017 study in the New England Journal of Medicine found that over 80% of patient advocacy organizations with annual revenues of at least $7.5 million reported receiving industry funding; another study in JAMA Internal Medicine found that approximately 65% of patient advocacy organizations with a median annual revenue of about $300,000 reported receiving industry funding; and a post on the Hastings Center’s website (and an earlier JAMA Internal Medicine editorial) reported that one pharmaceutical company funded an advocacy organization that, in turn, recruited other patient advocacy groups to speak in favor of the company’s drug when the FDA was considering approving it.  This last story highlights one area where the rubber meets the road with respect to FDA and patient advocates’ conflicts of interest: advisory committee meetings.

Advisory committees play an important role at FDA, including for new drug approvals.  Often when FDA is considering whether to approve a new drug, it will ask an advisory committee—a group of outside experts—to provide the agency with advice on various scientific questions about the drug.  At a typical drug-related advisory committee meeting, the drug company and FDA will each take a turn presenting the scientific evidence about the unapproved drug, then there will be an open public hearing at which any interested member of the public may speak, followed by the advisory committee’s discussion of, and vote on, the questions that FDA has posed to it.  Partly because advisory committee meetings may be the first public airing of the agency’s questions about an unapproved drug and partly because the agency follows advisory committee recommendations roughly 75% of the time, these meetings and recommendations frequently are closely watched.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.