United States: More Talk – No Action – From FDA On Off-Label "Communication"

Last Updated: September 6 2016
Article by James Beck

It's been over two years since the FDA – in March, 2014 Draft Guidelines and then in its June 2014 " grant" of an industry-submitted citizen's petition – promised to review its restrictions on so-called "off-label promotion" by regulated drug and medical device manufacturers.  We were skeptical at the time that all we would get is "still more agency bobbing and weaving."

Then two years with zilch – save more Agency First Amendment losses in off-label promotion cases.  Then industry gets sufficiently frustrated by FDA inaction on off-label communication issues that it starts to take matters into its own hands.

So, a month later, we finally hear from the FDA again.

Finally, some action?

Don't bet on it.

On August 31, 2016, a notice appeared in the Federal Register entitled "Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products; Public Hearing; Request for Comments."

Wonderful.  More talk, and the FDA kicks the can further down the road.  Once again the Agency refuses to recognizes the constitutional bind in which it finds itself.  Indeed, the term "First Amendment" doesn't appear anywhere – not even once – in the notice.  Nor does the FDA so much as utter the phrase "off-label."  Except for citations, the FDA uniformly uses the more pejorative term "unapproved."

If not the First Amendment, then, what do we have?

Well, the FDA asks for comments, meaning that regulated manufacturers get to spend more money paying their regulatory lawyers to repeat the same things one more time.  With respect to off-label communication:

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 comment and information addressing whether and in what ways firms' communications of unapproved use information are distinct and perhaps provide unique benefits compared to other sources.

Notice – online version – at "Background."  OK, while we think this has been done to death, at least the FDA is asking pertinent questions.  To us it has never made any sense that, while any unregulated Tom, Diane or Harry can say whatever s/he wants in about off-label use public on the Internet, the entities with responsibility for researching their products and conducting adverse event reporting are muzzled.

The FDA makes a lot of references to "scientific" or "medical" information that is "relevant," "truthful," and "non-misleading."  We like that kind of information too, but we don't see how off-label use is so much different.  All information about all drugs and their uses – on- or off-label – should have these characteristics.  The FDA has decades of experience with these considerations already, in the context of indicated uses.  We don't see what more is necessary.  Granted, "[n]ot all communications of information about unapproved uses help support public health."  But "communications that emphasize a medical product's claimed benefits, while minimizing the limitations of the supporting evidence, or minimizing the product's known or potential adverse effects," are problematic whether or not the use appears on product labeling.  The FDA already has regulations (and extensive enforcement experience) regarding these concerns in the context of promotional activities generally.  Off-label use isn't any different in this respect.

The notice contains eight general topics which the Agency seeks comment, most of those broken into multiple subtopics, for a total of about 25.  Here they are in brief:

1. The public health impact of off-label communication by regulated persons:

  • Benefits and risks to recipients from increased communication about off-label use, given that the information be "preliminary or inconclusive."
  • Effects on prescribing, development, and research concerning new potential product uses.
  • Effects on incentives for patients to enroll in clinical trials, and for manufacturers to conduct them.
  • Could the impact be different for drugs, as opposed to biologics, medical devices, and other categories of regulated products?

2. Impact of the changing structure of the health care system, and its need for better data.

  • Data needs of payors and formulary committees that influence prescribing decisions.
  • Whether changes in the healthcare system preserve, enhance, or reduce incentives for manufacturers to seek FDA review of new uses.

3. The impact of increasing availability of off-label information through various sources on the incentives for manufacturers to engage in such communications, along with other factors (including financial) that affect these incentives.

4. Standards for off-label communication that would minimize the potential for the information to be misleading or otherwise harmful.

  • Processes that manufacturers use to determine what evaluate when off-label information is sufficiently reliable to communicate to those in the health care field.
  • Criteria that the FDA could use for making the same reliability determinations.
  • The extent and variability of health care professionals' understanding of the reliability of available information about off-label uses, and whether different audiences need different presentations of the same information.

" What off-label information is most important for health care professionals' ability to evaluate the reliability of off-label information, and whether this varies depending on the audience.

5. Standards for FDA determination whether off-label communications are truthful and not misleading, and what the content of these communications should be (again, we wonder why this is different than for on-label information).

  • Appropriate off-label disclaimers and whether these should vary by the means of communication.
  • How to determine when communications actually involve off-label uses, and how these determinations are made.
  • What kinds of risk, reliability, and regulatory information should accompany off-label communications.
  • How to present disclosures in off-label communication so that they are most effective, particularly as to scientific reliability.
  • When and under what conditions are off-label communications to the public – patients and other consumers – appropriate.

6. The extent to which non-public data should be disclosed if it forms the basis for an off-label communication.

7. Appropriate types of surveillance and monitoring for the FDA to conduct concerning off-label communications.

8. The FDA has stopped hiding its proposed changes to 21 C.F.R. §§201.128 801.4 that it slipped into a tobacco-related notice (80 Fed. Reg. 57756), and seeks input about:

  • Additional regulatory changes concerning communications, including whose concerning "false and misleading," "adequate directions for use," and how "labeling" is defined.
  • The advantages and disadvantages of alternative regulatory approaches to off-label communications with respect to the FDA's public health mission.

So here we go again.  A lot of these requests resemble those appearing in prior FDA notices.  For more details, we recommend the FDA Law Blog's discussion.

Information regarding attendance, registration, commenting, and presenting is also included in the notice.  Comments on the FDA's proposal will be accepted until January 9, 2017.

This article is presented for informational purposes only and is not intended to constitute legal advice.

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
James Beck
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