United States: FDA Announces Public Hearing On Manufacturer Communications Regarding Off-Label Uses

On August 31, 2016, FDA announced that it will hold a two-day public hearing on November 9 and 10, 2016 to obtain input on issues related to manufacturer communications regarding drugs and medical devices, particularly communications regarding unapproved uses of approved or cleared products (i.e., "off-label" uses). FDA's notice is published in the Federal Register here.

This notice comes more than five years after the Medical Information Working Group ("MIWG"), an ad hoc coalition of drug and device manufacturers co-represented by Ropes & Gray, submitted its first Citizen Petition seeking clarity on FDA regulation of manufacturer communications, and nearly three years after the MIWG submitted a second Citizen Petition requesting that FDA review and modify its regulatory scheme in light of important developments in First and Fifth Amendment case law. FDA granted both Citizen Petitions in 2014 and initially promised to release guidance on discrete issues involving manufacturer communications within the year, but, so far, has not made good on its promise.1 The scheduling of this hearing, with the comment period open through January 9, 2017, suggests that these vital constitutional and public health issues will remain unresolved well into the next presidential administration.

This Alert summarizes the key aspects of FDA's announcement and the significance for regulated industry.

Framing the Discussion

FDA's Federal Register notice requests stakeholder comments addressing manufacturers' communications about medical products, with a particular focus on communications about unapproved uses of approved or cleared medical products, and reflects a careful framing by FDA of the discussion around its regulation of manufacturers' speech. Consistent with past agency statements, the notice emphasizes the importance of premarket review and cites a few examples, all of which are decades old, to illustrate the public health risks potentially associated with off-label communications. Furthermore, while courts have held that truthful, non-misleading off-label promotion is fully protected by the First Amendment,2 and that the Fifth Amendment requires government agencies such as FDA to issue clear and narrowly tailored rules when regulating speech,3 FDA largely fails to acknowledge the impact of these critical constitutional developments on its regulatory regime. In fact, there is only a single mention of constitutional considerations in the entire Federal Register notice, where FDA states that the purpose of FDA's review of its off-label policies is to "help ensure that our implementation of the FDA Authorities . . . best protects and promotes the public health in view of ongoing developments in science and technology, medicine, health care delivery, and constitutional law" (emphasis added).

Moreover, while FDA pays lip service to the practice-of-medicine doctrine—stating that "FDA generally does not seek to interfere with the exercise of the professional judgment of health care providers in prescribing, for unapproved uses for individual patients, most legally marketed medical products"—FDA does not appear to believe this doctrine should impact its regulation of off-label communications. Indeed, by emphasizing the necessity of FDA premarket review of all potential uses for a product, the agency would appear to be suggesting that health care professionals lack the judgment to analyze the risks and benefits of a product for a particular patient without FDA weighing in.

Purpose and Scope of the Public Hearing

The Federal Register notice poses more than two dozen questions about off-label communications for consideration by a broad group of stakeholders, including, but not limited to, health care professionals, payers, industry representatives, patients and patient advocates, and public interest groups. Of note, FDA's request does not appear to cover communications about pipeline products (i.e., products not yet marketed for any use), but only unapproved uses of products that have already been approved or cleared by the agency. Nevertheless, there may be some room for stakeholder comment on this point, as FDA has requested comment on areas where it could clarify regulations that touch on issues broader than the communication of off-label information. Specifically, FDA poses an open-ended question on "what additional changes, if any . . . FDA [should] consider in its regulations related to firms' communications about medical products, such as the regulations related to what is false or misleading, adequate directions for use, the definition of labeling, or other relevant provisions[.]"

Other notable questions posed by the agency include:

  • How could increased communications from manufacturers about unapproved uses impact the public health, and would the impact differ across different categories of medical products?
  • What criteria should FDA consider in determining whether a study or analysis that is the basis of a manufacturer's communication is scientifically appropriate to support the presentations or conclusions in the communication?
  • What factors should FDA consider in evaluating whether manufacturers' communications about unapproved uses of approved/cleared medical products are truthful and non-misleading, and what information should manufacturers disclose in these communications to help ensure audiences are not misled?
  • What kinds of surveillance and monitoring could be undertaken to measure the public health impacts of communications about unapproved uses?
  • To what extent is it appropriate for manufacturers to communicate information about unapproved uses of their approved/cleared medical products to patient and consumer audiences?

Implications of the Announcement

While FDA does acknowledge the need to reform and clarify its regulation of manufacturers' off-label communications, the hearing will likely delay agency action even further. Moreover, while it may be a valuable exercise to solicit public feedback on off-label communications, absent FDA action, the hearing will not provide regulated industry with the clarity it has repeatedly requested or do anything to bring FDA's regulatory framework into conformance with the First and Fifth Amendments.

Nevertheless, it will be important for stakeholders to weigh in on the questions posed by the agency for consideration, if and when FDA ultimately issues guidance or a proposed rule addressing off-label communications. Persons seeking to attend or present at the public hearing on November 9-10, 2016 must register by October 19, 2016. Comments on the Federal Register notice may be submitted to the agency until January 9, 2017.

Footnotes

1 See June 2014 Citizen Petition Response, FDA-2011-P-0512 and FDA-2013-P-1079. See also July 2011 Citizen Petition, FDA-2011-P-0512; September 2013 Citizen Petition, FDA-2013-P- 1079.

2 See United States v. Caronia, 703 F.3d 149 (2d Cir. 2012); Amarin Pharma, Inc. v. FDA, 119 F. Supp. 3d 196 (S.D.N.Y. 2015).

3 See FCC v. Fox Television Stations, 132 S. Ct. 2307 (2012).

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

Authors
Similar Articles
Relevancy Powered by MondaqAI
 
In association with
Related Topics
 
Similar Articles
Relevancy Powered by MondaqAI
Related Articles
 
Related Video
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
Mondaq on Twitter
 
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
 
Email Address
Company Name
Password
Confirm Password
Position
Mondaq Topics -- Select your Interests
 Accounting
 Anti-trust
 Commercial
 Compliance
 Consumer
 Criminal
 Employment
 Energy
 Environment
 Family
 Finance
 Government
 Healthcare
 Immigration
 Insolvency
 Insurance
 International
 IP
 Law Performance
 Law Practice
 Litigation
 Media & IT
 Privacy
 Real Estate
 Strategy
 Tax
 Technology
 Transport
 Wealth Mgt
Regions
Africa
Asia
Asia Pacific
Australasia
Canada
Caribbean
Europe
European Union
Latin America
Middle East
U.K.
United States
Worldwide Updates
Registration (you must scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions

Mondaq.com (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of www.mondaq.com

To Use Mondaq.com you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.

Disclaimer

The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.

General

Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions