Times, They Are A-Changin’

On Wednesday, FDA announced that it will hold a two-day public hearing on November 9th and 10th to obtain input from a broad cross-section of the health care industry, including pharmaceutical and medical device companies, doctors, patients, research institutions, health care organizations, and payors and insurers, regarding the appropriate regulation of manufacturers’ communications about off-label uses for their marketed medical products. Medical products include prescription drugs, biologics, medical devices, and animal drugs. This public meeting was originally “teased” by Agency officials as far back as April 2015, so it has been highly anticipated by all interested stakeholders. FDA’s announcement also comes after a series of high-profile losses for the Agency and the DOJ in the government’s attempt to prohibit and criminalize truthful, non-misleading off-label marketing.

For example, six months ago, on March 8, 2016, Amarin Pharma, Inc. and FDA entered into a formal settlement, close to a year after the U.S. District Court for the Southern District of New York granted a preliminary injunction against the Agency’s threats to treat Amarin’s proposed truthful and non-misleading off-label marketing about its drug, Vascepa, as violative of the Food, Drug, and Cosmetic Act (“FDCA”). As we blogged about previously here, the court ruled that FDA was impermissibly chilling truthful, non-misleading speech in violation of the First Amendment.

In the Amarin/FDA Settlement Agreement, FDA acknowledged that “Amarin may engage in truthful and non-misleading speech promoting the off-label use of Vascepa…and such speech may not form the basis of a prosecution for misbranding.” However, Amarin “bears the responsibility, going forward, of assuring that its communications to doctors regarding off-label use of Vascepa remain truthful and non-misleading.”

But such case-by-case negotiation between a company and FDA, whether driven by a court order or not, certainly is not sustainable for the Agency in the long term given the resources such a system would require. Accordingly, as it notes in this week’s meeting announcement, “FDA is currently engaged in a comprehensive review of the regulatory framework related to firms’ communications about unapproved uses of approved/cleared medical products.”

The Intersection of Protecting Free Speech and Promoting Public Safety

It now seems clear that FDA has recognized that, consistent with First Amendment principles, it cannot suppress or attempt to criminalize truthful and non-misleading speech under regulatory authorities granted to it by the Food Drug and Cosmetic Act. However, it now must face the tall task of formulating policies that are not only consistent with the First Amendment, but promote public safety while encouraging innovation and clinical research. In the formal notice of FDA’s public hearing, the Agency describes the tension between these different goals and mandates. It then provides a lengthy (and non-exhaustive, as the notice is clear to say) list of questions for which it is seeking input and views from affected stakeholders.  A sampling of those specific questions includes:

• “FDA is interested in comment on both the pros and cons for public health associated with firms’ communications of unapproved use information and the kinds of limitations or requirements that would be appropriate to protect patients from harm.”

• “FDA is interested in comment on the extent to which additional communications from firms about unapproved uses can provide access to information that is relevant, scientifically sound, responsibly presented, and provides as full an understanding as possible about the limitations of the available evidence, as well as comment on the extent to which health care professionals currently face impediments to accessing such information, whether from firms or from other sources.”

• “FDA is interested in input from stakeholders on factors the Agency should consider in evaluating whether firms’ communications about unapproved uses of approved/cleared medical products are truthful and non-misleading, including what information firms should disclose in these communications to help ensure audiences are not misled, and on general considerations related to the audience for these communications and on communication vehicles and techniques.”

• “What are the benefits, [drawbacks, or risks] for clinical decision-making, research, coverage, reimbursement, or other purposes if firms communicate to health care professionals, payers, researchers, and patients more information, including preliminary or inconclusive information, about unapproved uses of approved/cleared medical products?”

• And one that may be of special interest to regular readers of this blog, “To what extent do changes occurring in the health care system that give payors and formulary committees more influence on prescribing decisions (including by denying, limiting, or endorsing coverage of unapproved uses of approved medical products) provide incentives for firms to generate the high-quality data needed to demonstrate safety and effectiveness for new uses?”

FDA’s complete list of questions can be reviewed in the Federal Register notice for the November hearing (here), and written comments should be submitted to the relevant docket (FDA-2016-N-1149) by January 9, 2017.  In addition, we recommend that any person who wishes to attend in person the public hearing at FDA’s campus in Maryland register as soon as possible – the instructions for registration are available here.  Although the registration deadline is October 16, in-person registration for all FDA meetings is first-come, first-served, and once the conference center is full, the system will be closed.  Please note that you do not have to attend the meeting in order to file written comments, and FDA also plans to stream a live webcast of the event to permit all interested persons to participate.