United States: Amarin Court Holds Truthful Off-Label Speech Entitled To First Amendment Protection

On August 7, 2015, the U.S. District Court for the Southern District of New York issued an opinion in Amarin Pharma, Inc. v. FDA, granting Amarin preliminary relief to engage in truthful and non-misleading off-label speech about its triglyceride-lowering drug, Vascepa. The court ruled that Amarin may make certain truthful statements about Vascepa's potential benefits for patients with "persistently high triglycerides," despite the drug lacking FDA approval for that use. Relying on the 2012 Second Circuit decision in United States v. Caronia, the court determined that Amarin's proposed off-label speech was constitutionally protected and could not, on its own, form the basis of a misbranding charge. 


In 2012, FDA approved Vascepa, an omega-3 fatty acid, for the treatment of adult patients with triglyceride levels above 500 mg/dL of blood (i.e., "severe hypertriglyceridemia")—a patient population at increased risk of pancreatitis and cardiovascular disease. Amarin subsequently sought an indication for Vascepa to treat patients with triglyceride levels between 200 and 499 mg/dL despite being on statin therapy (i.e., "persistently high triglycerides"). Amarin's clinical research demonstrated with statistical significance that Vascepa was safe and effective in reducing persistently high triglyceride levels, but FDA determined, based on the results of clinical trials of other drugs, that lowering triglyceride levels was not an established surrogate for reducing cardiovascular risk in this patient population. FDA accordingly denied Amarin's supplemental application and made clear in a Complete Response Letter ("CRL") that it would consider Vascepa to be misbranded if Amarin marketed the drug for patients with persistently high triglycerides without approval. 

After receiving the CRL, Amarin filed its complaint in the district court and subsequently moved for a preliminary declaration from the court and a preliminary injunction, arguing that the First Amendment permits it to engage in truthful and non-misleading speech about the off-label use of Vascepa. Amarin sought protection to make "carefully-circumscribed, truthful, and scientifically-accurate statements" when promoting the potential effects of Vascepa on coronary heart disease in patients with persistently high triglycerides and for providing doctors with peer-reviewed scientific publications about the off-label use. The Company also noted that FDA currently permits manufacturers of dietary supplements containing a chemically identical omega-3 fatty acid to make a qualified health claim about coronary artery disease similar to the one proposed by Amarin. The Medical Information Working Group, co-represented by Ropes & Gray, filed an amicus brief in support of Amarin. 


Granting Amarin's request for preliminary relief, the court declared that (1) Amarin may engage in truthful and non-misleading speech promoting the off-label use of Vascepa to treat patients with persistently high triglycerides, and under Caronia, such speech may not form the basis of a prosecution for misbranding, and (2) based on the information presently known, the combination of statements and disclosures that Amarin proposes to make to doctors, as modified by the court, are truthful and non-misleading. 

Caronia Broadly Protects Truthful and Non-Misleading Speech

The court relied extensively on the Caronia decision to support its ruling. In 2012, the Second Circuit vacated a conviction of a drug manufacturer's sales representative for conspiracy to misbrand the drug Xyrem by promoting it for unapproved uses. The Second Circuit held that a drug manufacturer's speech promoting an off-label use is constitutionally protected commercial speech, and that the Federal Food, Drug, and Cosmetic Act ("FFDCA") would "run afoul of the First Amendment" if it were construed to criminalize the mere promotion of a drug's off-label use by a manufacturer. FDA argued that Caronia was a fact-bound decision that turned on the particular jury instructions given in that case, and that it did not generally preclude the government from bringing a misbranding action for truthful and non-misleading statements promoting an off-label use. Ruling on Amarin's motion for preliminary relief, the court disagreed. In particular, the court held that Caronia was "categorical, rather than case-specific" and that the First Amendment protects all truthful and non-misleading off-label speech, including proactive, promotional statements made by a pharmaceutical manufacturer. 

No Protection for False or Misleading Speech 

Although the court found that Amarin's truthful and non-misleading speech is protected and may not serve as the basis for a misbranding charge, it noted that the government's authority to prosecute manufacturers for off-label marketing remains intact against false or misleading speech, which is not entitled to First Amendment protection. The court carefully reviewed the promotional statements that Amarin proposed to make, including the contextual information and disclosures that Amarin proposed to accompany those statements, and, with certain modifications identified by the court, found them to be protected because they were truthful and non-misleading. In so doing, the court noted that the "unusual and extensive regulatory history" relating to Vascepa made it possible to determine the truthfulness of Amarin's proposed statements at this early stage of litigation.

When Speech Can Be Evidence of Intended Use

The court acknowledged that although truthful and non-misleading off-label speech, without more, cannot form the basis for an FFDCA violation, a manufacturer's speech may serve as evidence of intent where the conduct in question is not purely speech-based. For example, if a manufacturer paid doctors or bought them resort vacations to reward off-label prescribing, the manufacturer's truthful statements promoting off-label use could be admissible to prove that its intent in paying the doctors had been to promote off-label (as opposed to on-label) use.


The ultimate implications for FDA-regulated industry remain to be seen. For the moment, the case remains the opinion of one district court, and the government has 60 days within which to appeal to the Second Circuit. Although the court correctly rejected the government's assertion that protecting truthful and non-misleading off-label speech would constitute a "frontal assault" on the FFDCA's new drug approval requirements, the rationale of the Amarin court does call into question a number of key features of FDA's regulations and policies governing manufacturer speech—particularly as they relate to purported distinctions between proactive promotional statements and responses to unsolicited requests, or promotional communications and scientific exchange. Thus, at a minimum, we expect the decision will encourage FDA to expedite review of its promotional policies to align them with First Amendment principles. The decision should also provide helpful support to pharmaceutical and medical device manufacturers in cases where the government seeks to enforce the FFDCA based on allegations of truthful and non-misleading off-label promotion. 

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.

In association with
Related Video
Up-coming Events Search
Font Size:
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
Confirm Password
Mondaq Topics -- Select your Interests
 Law Performance
 Law Practice
 Media & IT
 Real Estate
 Wealth Mgt
Asia Pacific
European Union
Latin America
Middle East
United States
Worldwide Updates
Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:
  • To allow you to personalize the Mondaq websites you are visiting.
  • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our information providers who provide information free for your use.
  • Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.
    If you do not want us to provide your name and email address you may opt out by clicking here
    If you do not wish to receive any future announcements of products and services offered by Mondaq you may opt out by clicking here

    Terms & Conditions and Privacy Statement

    Mondaq.com (the Website) is owned and managed by Mondaq Ltd and as a user you are granted a non-exclusive, revocable license to access the Website under its terms and conditions of use. Your use of the Website constitutes your agreement to the following terms and conditions of use. Mondaq Ltd may terminate your use of the Website if you are in breach of these terms and conditions or if Mondaq Ltd decides to terminate your license of use for whatever reason.

    Use of www.mondaq.com

    You may use the Website but are required to register as a user if you wish to read the full text of the content and articles available (the Content). 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 & conditions or with the prior written consent of Mondaq Ltd. You may not use electronic or other means to extract details or information about Mondaq.com’s content, users or contributors in order to offer them any services or products which compete directly or indirectly with Mondaq Ltd’s services and products.


    Mondaq Ltd and/or its respective suppliers make no representations about the suitability of the information contained in the documents and related graphics published on this server for any purpose. All such documents and related graphics are provided "as is" without warranty of any kind. Mondaq Ltd and/or its respective suppliers hereby disclaim all warranties and conditions with regard to this information, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Mondaq Ltd 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 or performance of information available from this server.

    The documents and related graphics published on this server could include technical inaccuracies or typographical errors. Changes are periodically added to the information herein. Mondaq Ltd and/or its respective suppliers may make improvements and/or changes in the product(s) and/or the program(s) described herein at any time.


    Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:

    • To allow you to personalize the Mondaq websites you are visiting.
    • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
    • To produce demographic feedback for our information providers who provide information free for your use.

    Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.

    Information Collection and Use

    We require site users to register with Mondaq (and its affiliate sites) to view the free information on the site. We also collect information from our users at several different points on the websites: this is so that we can customise the sites according to individual usage, provide 'session-aware' functionality, and ensure that content is acquired and developed appropriately. This gives us an overall picture of our user profiles, which in turn shows to our Editorial Contributors the type of person they are reaching by posting articles on Mondaq (and its affiliate sites) – meaning more free content for registered users.

    We are only able to provide the material on the Mondaq (and its affiliate sites) site free to site visitors because we can pass on information about the pages that users are viewing and the personal information users provide to us (e.g. email addresses) to reputable contributing firms such as law firms who author those pages. We do not sell or rent information to anyone else other than the authors of those pages, who may change from time to time. Should you wish us not to disclose your details to any of these parties, please tick the box above or tick the box marked "Opt out of Registration Information Disclosure" on the Your Profile page. We and our author organisations may only contact you via email or other means if you allow us to do so. Users can opt out of contact when they register on the site, or send an email to unsubscribe@mondaq.com with “no disclosure” in the subject heading

    Mondaq News Alerts

    In order to receive Mondaq News Alerts, users have to complete a separate registration form. This is a personalised service where users choose regions and topics of interest and we send it only to those users who have requested it. Users can stop receiving these Alerts by going to the Mondaq News Alerts page and deselecting all interest areas. In the same way users can amend their personal preferences to add or remove subject areas.


    A cookie is a small text file written to a user’s hard drive that contains an identifying user number. The cookies do not contain any personal information about users. We use the cookie so users do not have to log in every time they use the service and the cookie will automatically expire if you do not visit the Mondaq website (or its affiliate sites) for 12 months. We also use the cookie to personalise a user's experience of the site (for example to show information specific to a user's region). As the Mondaq sites are fully personalised and cookies are essential to its core technology the site will function unpredictably with browsers that do not support cookies - or where cookies are disabled (in these circumstances we advise you to attempt to locate the information you require elsewhere on the web). However if you are concerned about the presence of a Mondaq cookie on your machine you can also choose to expire the cookie immediately (remove it) by selecting the 'Log Off' menu option as the last thing you do when you use the site.

    Some of our business partners may use cookies on our site (for example, advertisers). However, we have no access to or control over these cookies and we are not aware of any at present that do so.

    Log Files

    We use IP addresses to analyse trends, administer the site, track movement, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information.


    This web site contains links to other sites. Please be aware that Mondaq (or its affiliate sites) are not responsible for the privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of these third party sites. This privacy statement applies solely to information collected by this Web site.

    Surveys & Contests

    From time-to-time our site requests information from users via surveys or contests. Participation in these surveys or contests is completely voluntary and the user therefore has a choice whether or not to disclose any information requested. Information requested may include contact information (such as name and delivery address), and demographic information (such as postcode, age level). Contact information will be used to notify the winners and award prizes. Survey information will be used for purposes of monitoring or improving the functionality of the site.


    If a user elects to use our referral service for informing a friend about our site, we ask them for the friend’s name and email address. Mondaq stores this information and may contact the friend to invite them to register with Mondaq, but they will not be contacted more than once. The friend may contact Mondaq to request the removal of this information from our database.


    From time to time Mondaq may send you emails promoting Mondaq services including new services. You may opt out of receiving such emails by clicking below.

    *** If you do not wish to receive any future announcements of services offered by Mondaq you may opt out by clicking here .


    This website takes every reasonable precaution to protect our users’ information. When users submit sensitive information via the website, your information is protected using firewalls and other security technology. If you have any questions about the security at our website, you can send an email to webmaster@mondaq.com.

    Correcting/Updating Personal Information

    If a user’s personally identifiable information changes (such as postcode), or if a user no longer desires our service, we will endeavour to provide a way to correct, update or remove that user’s personal data provided to us. This can usually be done at the “Your Profile” page or by sending an email to EditorialAdvisor@mondaq.com.

    Notification of Changes

    If we decide to change our Terms & Conditions or Privacy Policy, we will post those changes on our site so our users are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose it. If at any point we decide to use personally identifiable information in a manner different from that stated at the time it was collected, we will notify users by way of an email. Users will have a choice as to whether or not we use their information in this different manner. We will use information in accordance with the privacy policy under which the information was collected.

    How to contact Mondaq

    You can contact us with comments or queries at enquiries@mondaq.com.

    If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at problems@mondaq.com and we will use commercially reasonable efforts to determine and correct the problem promptly.

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