Guest Post – The FDA’s Two-Day Meeting on Manufacturer Off-Label Communications

by Reed Smith

Today’s guest post is by Liz Minerd, a Reed Smith associate, who closely followed the online feed of  the recent FDA meeting that the Agency called to discuss what changes would be appropriate in its off-label promotion restrictions – although the official agenda steered away from both the terms “off-label” and “promotion”.  What follows is her summary of two days of testimony from over 60 speakers, some of whom thought that it was crazy that any damn fool can say whatever s/he wants about off-label uses, except for manufacturers, who can’t even tell the truth although knowing the most about them due to ongoing pharmacovigilance obligations, and other speakers who … do not.

As always, our guest poster deserves 100% of the credit (and any blame) for her post.  We’re only the piano-players.  Take it away Liz.


Last Wednesday and Thursday (Nov. 9-10, 2016), the FDA conducted a public meeting on “Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products.”  The FDA’s notice of the meeting (available here) stated:

FDA is engaged in a comprehensive review of its regulations and policies governing firms’ communications about unapproved uses of approved/cleared medical products, and the input from this meeting will inform FDA’s policy development in this area.

What that means, stripped of regulatory jargon, is that the FDA public meeting involved potential updating of the FDA’s decades-old prohibition on truthful promotion of off-label uses by regulated manufacturers.

Over the course of two days, some 60 speakers presented diverse viewpoints about the FDA’s current position on off-label communications, with the first day predominantly consisting of those in favor of easing restrictions and the second day of those in favor maintaining or increasing those restrictions.

Speakers advocating for an easing of the restrictions on off-label communications included the main participants in our healthcare system:  (1) drug and device manufacturers, (2) third-party payors, (3) physicians, and (4) patients.  Also speaking on this side were free speech advocates, even though the FDA’s notice (as the Blog pointed out at the time) did not mention the First Amendment.  But even among these speakers, there were differences in opinion as to, (i) who should receive the off-label communications and (ii) how much evidence should underlie the communication.

First, these speakers generally agreed that a manufacturer should be allowed to have expanded off-label communications with payors so that the payors would have sufficient information to develop formularies.  Both the manufacturers and the payors focused on delays in getting drugs added to formularies in a timely manner if they are not able to communicate regarding new drugs (or new indications for drugs) until after approval of labeling recognizing new uses.  They also advocated for allowing payors to receive post-approval off-label information to allow payors to make value-based decisions on coverage.

In addition, many (but not all) of these speakers supported allowing more opportunities for off-label manufacturer communications with physicians. In particular, physicians treating patients who suffer from rare or pediatric diseases—where off-label use is often the standard of care, because no labeled uses exist—advocated for allowing robust off-label discussions provided that they are backed by scientific evidence.  On the device side, both manufacturers and physicians advocated for easing restrictions on off-label communications, because physicians often need technical assistance to use/program devices and restrictions on off-label communications can deprive those physicians of such assistance for off-label uses, thereby resulting in patient harm.

Only a few speakers advocated for allowing direct to consumer off-label communications. Those who advocated this position focused on the trend in patients taking a more active role in learning about their own medical care and the difficulty of restricting the flow of information where patients are performing their own internet research.

Second, speakers advocating for an easing of restrictions generally agreed that off-label communications should be based on scientific evidence.  But opinions varied widely on how much scientific evidence should be required—from requiring peer review to accepting anecdotal or real-world experience evidence.  Many recognized that it is too restrictive to only permit dissemination of re-prints because many physicians do not have the time to read full articles.  Several speakers suggested that disclaimers could be used to provide context and further information to allow physicians to assess the level of evidentiary support for off-label information.

Several speakers expressed frustration with the FDA because the FDA has repeatedly delayed issuing clear guidance in this area, and the FDA’s notice for the meeting only fleetingly mentioned the constitutional concerns. These speakers questioned whether the FDA is looking at potential changes to regulations of off-label communications through the appropriate framework if it is not focused on the recent First Amendment jurisprudence: United States v. Caronia, 703 F.3d 149 (2d Cir. 2012), and Amarin Pharma, Inc. v. FDA, 119 F. Supp.3d 196 (S.D.N.Y. 2015), in particular, and Sorrell v. IMS Health Inc., 564 U.S. 552 (2011), and Thompson v. Western States Medical Center, 535 U.S. 357 (2002), more generally.

Speakers advocating for increased restrictions on manufacturer off-label communications often cited historical examples of harm that occurred from unregulated drugs prior to the enactment of the FDCA.  These speakers included:  (1) family members of patients harmed by off-label use, (2) plaintiff-side consumer advocacy groups, (3) similarly pro-plaintiff public health research groups/academics, and (4) a whistleblower.

These speakers largely ignored the First Amendment implications of FDA regulation of off-label communications. Those who didn’t ignore the First Amendment argued that the recent jurisprudence was wrongly decided, should be narrowly interpreted, or, in the case of Amarin, non-binding.  Some also implied that manufacturers’ claims of First Amendment protection should be discounted or ignored because those manufacturers restrict patient/plaintiffs’ speech through confidentiality provisions included in settlement agreements.

Many of the speakers advocating for increased restrictions argued that manufacturers should not even be allowed to provide physicians with re-prints of articles. These speakers contended that the peer reviewed process is flawed, resulting in the publication of articles with little evidentiary basis.  These speakers pointed to alleged “ghost-writing” and use of paid consultants by manufacturers to disseminate off-label information that, according to the speakers, already results in over-prescribing off-label uses.  In their eyes, the FDA should be the only arbiter of whether information is backed by sufficient scientific evidence to justify permitted a manufacturer to disseminate it to physicians.  These speakers argued that off-label uses backed by sufficient scientific evidence will not be kept a “secret” from physicians even if manufacturers are not permitted to disseminate information on these uses because physicians will learn of such uses from medical societies.

At the most extreme, some speakers advocated for the FDA to insert itself into the doctor-patient relationship (something that is illegal under 21 U.S.C. §396) and require physicians to obtain separate informed consent (potentially even provided by the FDA) before prescribing or using a drug or device off-label.

The FDA will be accepting written comments until January 9, 2017. Instructions for submitting written comments are available here.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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