FDA Advisory Committees and Industry-Funded Patient Advocacy

by Patti Zettler — Friday, June 23, 2017@pzettler

Cross-posted on Objective Intent and Stanford’s Law and the Biosciences Blog.

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 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 Hastings Center post focused on Addyi, a drug that FDA ultimately approved for low sexual desire in women—sometimes described as “Viagra for women”—and the subject of one such closely-watched advisory committee meeting.  Before the FDA’s approval decision, Sprout Pharmaceuticals, Addyi’s developer, helped to create and fund an advocacy group called “Even the Score,” a self-described “campaign for women’s sexual health equity.”  According to the Hasting Center’s website and other reports, at the June 2015 advisory committee meeting about Addyi, many of the speakers at the open public hearing advocated for the drug’s approval—and had received money from Sprout Pharmaceuticals (e.g., for travel expenses), or were representatives of the organizations in Even the Score’s coalition, raising concerns about conflicts of interest.

The problem of conflicts of interest at advisory committee meetings is nothing new. FDA requires that advisory committee members who are special government employees or regular government employees disclose financial conflicts of interest (and has several guidance documents on advisory committee members’ conflicts), and GSA’s regulations on advisory committees require that the interests and affiliations of committee members are reviewed for compliance with any applicable conflict of interest requirements.   But the question that industry-funding of patient advocacy organizations raises is, of course, a different one.  That is, what should (and can) be done about conflicts of interest not among the members of the advisory committee, but among those speaking during the public hearing of an advisory committee (or submitting written comments to the committee)?

FDA already recommends, in a guidance document, that open public hearing speakers disclose financial conflicts of interest and that the Chair of the advisory committee make a statement encouraging such disclosure.  At the June 2015 meeting on Addyi, these recommendations seem to have been followed.  Yet concerns have persisted that the presentations at the open public hearing may have inappropriately swayed the advisory committee’s positive assessment of the drug and the FDA’s 2015 decision to approve the drug (after rejecting it twice before).

The authors of the post on the Hastings Center website suggest, among other things, that the FDA should ban industry-funded speakers and representatives of industry-funded organizations from participating in open public hearings at advisory committee meetings.  This proposal is arguably consistent with the Federal Advisory Committee Act’s (FACA) intent that advisory committee recommendations not be “inappropriately influenced . . . by any special interest.”  But a complete ban on participation seems a stretch—both as a practical matter, because of current interest in “patient-focused” drug development, and a legal matter.  Leaving aside any First Amendment issues with such a ban, section 10 of FACA provides that “interested persons shall be permitted to attend, appear before, or file statements with any advisory committee, subject to . . . reasonable rules and regulations” (emphasis added).

So what more might the FDA do? The agency, perhaps, could transform its recommendation for disclosure into a requirement for disclosure through rulemaking.  But such a measure may not be worth the trouble if the agency’s recommendation for disclosure is generally followed, particularly in the current political climate. And, of course, disclosure is not likely to be a panacea for conflicts of interest even if formally required.

This is not, however, to say the agency cannot, or should not do, anything.  The most viable option may be for the agency to review and tweak its processes for managing public input for advisory committees.  There may be ways to further encourage full disclosures by those speaking at open public hearings (and those who submit written comments for advisory committees), to help advisory committee members properly account for those disclosures in their discussions and recommendations, and to try to ensure fair representation of viewpoints at the open public hearing. For example, for those meetings for which there are more requests to present than can be accommodated in the open public hearing session, the agency may conduct a lottery to determine who is allotted time to speak.  For such meetings, the agency might consider whether it could account for conflicts of interest in allotting spots to help ensure fair representation.  Ultimately, it seems worthwhile for the FDA to do what it can to mitigate conflicts of interest among those providing input at advisory committee meetings, because of the prevalence of industry support for patient advocacy organizations, the current emphasis on incorporating patient voices into the FDA process, and the importance of advisory committee recommendations.

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About Patti Zettler

Patti Zettler is an associate professor and a faculty member of the Center for Law, Health & Society at Georgia State University College of Law in Atlanta, GA. She teaches and writes about the U.S. Food and Drug Administration, health law and policy, and torts. Prior to joining Georgia State, she was a fellow at the Center for Law and the Biosciences at Stanford Law School, and, before that, she served as an associate chief counsel in the FDA’s Office of the Chief Counsel. She also has bioethics experience through work at the Program in Medical Ethics at the University of California San Francisco and at the Department of Bioethics at the National Institutes of Health. She received her undergraduate and law degrees from Stanford, both with distinction.

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