United States: Podcast: FDA Holds Public Hearing On Manufacturer Communication Of Scientific And Medical Information

In this podcast, Doug Hallward-Driemeier, chair of Ropes & Gray's appellate and supreme court practice, moderates a discussion with partner Kellie Combs and senior counsel Alan Bennett about the FDA's open hearings regarding off-label communications. 


Doug Hallward-Driemeier: I'm Doug Hallward-Driemeier, Chair of Ropes & Gray's appellate and Supreme Court practice. I'm here today with partner Kellie Combs and senior counsel Alan Bennett, from our FDA Life Sciences practice, to discuss this week's open FDA hearings regarding off-label communications. We've seen a growing concern among pharmaceutical and medical device manufacturers over the degree to which FDA regulates off-label communication. And, Kellie, you testified at the FDA open hearings on November 9, on behalf of the Medical Information Working Group, a coalition of more than a dozen drug and device manufacturers seeking changes to FDA's regulatory scheme. So, tell us about the hearings, about your testimony, and whether you think it was a significant step toward meaningful reform.

Kellie Combs: Sure, Doug, I'd be happy to. The MIWG has been urging the FDA for nearly ten years now to clarify its regulatory framework governing manufacturer speech, and in 2014 the agency actually promised to issue guidance later that year, in four critical areas: scientific exchange, payer communications, responses to unsolicited requests and dissemination of clinical practice guidelines. So, the agency also promised, at that time, to engage in a comprehensive review of its policies to determine whether any revisions were necessary in view of First and Fifth Amendment limitations. Unfortunately, more than two years have now passed, and we haven't had any meaningful action from FDA. So, at the hearing, we emphasized that because off-label use is common that it's absolutely essential there be clear pathways for manufacturers to actually provide scientific and medical information about those off label uses to healthcare professionals and to payers. And, then we also described the First and Fifth Amendment principles that the agency needs to be mindful of in this space. In particular, that FDA can't restrict manufacturers from providing truthful and non-misleading information, even if it is off-label, unless those restrictions are clear, precise and narrowly drawn to advance a compelling interest. And, then finally, we urged the agency to issue those four overdue guidance documents immediately so that industry could finally have clarity on how to communicate in those areas and so that valuable information could be shared to inform treatment decisions.

DHD: And I know that you had prepared remarks, as did the other speakers, but I also know that, somewhat unexpectedly, it was a fairly live active panel from the FDA, and so they were asking questions. So, did their questions give you any hint of where you think FDA is going with this?

KC: You know, I think I and many of us were pleasantly surprised at how engaged the agency actually was. The panelists asked really thoughtful, substantive questions of almost all the speakers, and it was really clear from the questions that the panel, number one, recognizes that there is value in off-label communications, and that additional clarity and flexibility is needed. But, number two, the panelists really appeared to be grappling with how to implement the clarity and flexibility that everyone knows is needed.

Alan Bennett: Kellie, I would add something to that. As you said, the panel was quite involved, and I think they were probing the outer boundaries of our arguments. Questions like do we view the rules for consumer audiences and professional audiences as the same, who judges what's true, and what's the appropriate standard for evaluating data are all designed to see how far free speech advocates are willing to push the arguments.

KC: Yeah, Alan, I think that's a really good point, and you know, Doug, I would be interested in your view on this. So one of the questions we heard repeatedly over the course of the two days, is that, you know the panel has expressed some concern that off-label communications could ultimately lead to patient harm, and that as a result there should be greater restrictions on the extent to which manufacturers could share off-label information. How would you respond to that concern?

DHD: Because I look at this from a constitutional perspective, I think that the FDA is looking at this sort of from the wrong angle. They're trying to ask what are the justifications for allowing the speech, when what the constitution requires is that you look at what are the justifications the government has to limit this speech. And, they're limiting speech that is actually quite valuable, and, as a consequence, doctors are less informed as they make decisions about their patient care than they should be. But the fact that the speech is First Amendment protected doesn't mean that the government doesn't have any role to play, or that all speech, necessarily, is going to get out, even really unfounded claims. The government has a role, but it has to justify restrictions. And right now what the government is doing is imposing limitations on manufacturers' ability to speak, such as requiring they have two well-controlled randomized trials for anything they want to say, that the government itself does not apply to its own speech. FDA, CDC, ACIP, all rely on much different evidence and much lesser forms of evidence than it demands of the manufacturers, and that is what the First Amendment really doesn't allow, is that the government assigns itself the role of arbiter of truth, and setting up a rule that manufacturers can't speak unless the government allows it to. So I think that the meeting is going to be very important, to the extent that it sort of really compels FDA to grapple with that. I wanted to turn it back, though, to Alan, because you've been at this for 25 years. You have seen a long history of development here. I want to get your sense of where we have we come from, and where do you see this going.

AB: Well, it has been a long while, Doug, and it's interesting to look back. I think you have to look at that question in a couple of different ways. As a strictly regulatory matter, change, in fact, has been minimal over the last 25 years. FDA's policies haven't budged, and the agency strongly resists efforts to modify those policies and guidance, regulation or law. I would say, at a more practical level, the agency's interest in forcing some of those policies has been curtailed in recent years, in certain circumstances. For example, if a company has strong, adequate and well-controlled studies about an endpoint that's consistent with the label, it might consider options in a way that it might not have 5 or 10 years ago. While the regulatory scheme has not budged much, on a policy level I've never seen the agency under such immense pressure to make changes. Some of this comes from the way information is disseminated today, and the increasing need for information from physicians, from doctors, from payers. But we also can't forget the outside pressure that the courts are bringing by applying First Amendment principles to the regulatory system. I don't think the current set of rules and policies can survive. A new system is being born, based on truthful, non-misleading speech accompanied by adequate disclosures, but we don't know yet exactly what the contours of that system will be. That will make the next several years quite interesting for those who practice in this area.

DHD: Interesting, indeed, and we will keep you informed of future developments. Thank you, Alan and Kellie, for sharing your insights, and thank you for listening.

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.

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
Font Size:
Mondaq on Twitter
Mondaq Free Registration
Gain access to Mondaq global archive of over 375,000 articles covering 200 countries with a personalised News Alert and automatic login on this device.
Mondaq News Alert (some suggested topics and region)
Select Topics
Registration (please 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.


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.


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