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

by Reed Smith
Contact

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.

© Reed Smith | Attorney Advertising

Written by:

Reed Smith
Contact
more
less

Reed Smith on:

Readers' Choice 2017
Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Custom Email Digest
Privacy Policy (Updated: October 8, 2015):
hide

JD Supra provides users with access to its legal industry publishing services (the "Service") through its website (the "Website") as well as through other sources. Our policies with regard to data collection and use of personal information of users of the Service, regardless of the manner in which users access the Service, and visitors to the Website are set forth in this statement ("Policy"). By using the Service, you signify your acceptance of this Policy.

Information Collection and Use by JD Supra

JD Supra collects users' names, companies, titles, e-mail address and industry. JD Supra also tracks the pages that users visit, logs IP addresses and aggregates non-personally identifiable user data and browser type. This data is gathered using cookies and other technologies.

The information and data collected is used to authenticate users and to send notifications relating to the Service, including email alerts to which users have subscribed; to manage the Service and Website, to improve the Service and to customize the user's experience. This information is also provided to the authors of the content to give them insight into their readership and help them to improve their content, so that it is most useful for our users.

JD Supra does not sell, rent or otherwise provide your details to third parties, other than to the authors of the content on JD Supra.

If you prefer not to enable cookies, you may change your browser settings to disable cookies; however, please note that rejecting cookies while visiting the Website may result in certain parts of the Website not operating correctly or as efficiently as if cookies were allowed.

Email Choice/Opt-out

Users who opt in to receive emails may choose to no longer receive e-mail updates and newsletters by selecting the "opt-out of future email" option in the email they receive from JD Supra or in their JD Supra account management screen.

Security

JD Supra takes reasonable precautions to insure that user information is kept private. We restrict access to user information to those individuals who reasonably need access to perform their job functions, such as our third party email service, customer service personnel and technical staff. However, please note that no method of transmitting or storing data is completely secure and we cannot guarantee the security of user information. Unauthorized entry or use, hardware or software failure, and other factors may compromise the security of user information at any time.

If you have reason to believe that your interaction with us is no longer secure, you must immediately notify us of the problem by contacting us at info@jdsupra.com. In the unlikely event that we believe that the security of your user information in our possession or control may have been compromised, we may seek to notify you of that development and, if so, will endeavor to do so as promptly as practicable under the circumstances.

Sharing and Disclosure of Information JD Supra Collects

Except as otherwise described in this privacy statement, JD Supra will not disclose personal information to any third party unless we believe that disclosure is necessary to: (1) comply with applicable laws; (2) respond to governmental inquiries or requests; (3) comply with valid legal process; (4) protect the rights, privacy, safety or property of JD Supra, users of the Service, Website visitors or the public; (5) permit us to pursue available remedies or limit the damages that we may sustain; and (6) enforce our Terms & Conditions of Use.

In the event there is a change in the corporate structure of JD Supra such as, but not limited to, merger, consolidation, sale, liquidation or transfer of substantial assets, JD Supra may, in its sole discretion, transfer, sell or assign information collected on and through the Service to one or more affiliated or unaffiliated third parties.

Links to Other Websites

This Website and the Service may contain links to other websites. The operator of such other websites may collect information about you, including through cookies or other technologies. If you are using the Service through the Website and link to another site, you will leave the Website and this Policy will not apply to your use of and activity on those other sites. We encourage you to read the legal notices posted on those sites, including their privacy policies. We shall have no responsibility or liability for your visitation to, and the data collection and use practices of, such other sites. This Policy applies solely to the information collected in connection with your use of this Website and does not apply to any practices conducted offline or in connection with any other websites.

Changes in Our Privacy Policy

We reserve the right to change this Policy at any time. Please refer to the date at the top of this page to determine when this Policy was last revised. Any changes to our privacy policy will become effective upon posting of the revised policy on the Website. By continuing to use the Service or Website following such changes, you will be deemed to have agreed to such changes. If you do not agree with the terms of this Policy, as it may be amended from time to time, in whole or part, please do not continue using the Service or the Website.

Contacting JD Supra

If you have any questions about this privacy statement, the practices of this site, your dealings with this Web site, or if you would like to change any of the information you have provided to us, please contact us at: info@jdsupra.com.

- hide
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.