United States: The Titanic Is Sinking: Caronia, Amarin And Now Pacira V FDA

Last Updated: September 11 2015
Article by Michael A. Walsh and Katherine McGahey

In 2011, the US Supreme Court decided Sorrell v US, holding that "[s]peech in aid of pharmaceutical marketing . . . is a form of expression protected by the Free Speech Clause of the First Amendment." This one phrase stated matter-of-factly what was unthinkable a generation earlier. Sorrell was a watershed event for how the Supreme Court views the First Amendment in the context of FDA-regulated industry.

In 2012 the Second Circuit decided US v Caronia. In reversing Caronia's conviction, the Second Circuit ruled that the FDA's enforcement of the Food Drug and Cosmetic Act (FDCA) violated Caronia's First Amendment rights, stating: "We conclude simply that the government cannot prosecute pharmaceutical manufacturers and their representatives under the FDCA for speech promoting the lawful, off-label use of an FDA-approved drug." (See our discussion of Caronia here). Some commentators were outraged at the implications of Caronia and foretold undoing the work attributed to Frances Oldham Kelsey and a return to the horrors of products marketed without adequate warnings. Though the world today is very different than the world of Kelsey, the FDA Titanic nonetheless holds on to old arguments, while failing to meet new challenges.

As demonstrated in Sorrell and Caronia, it takes unusual facts for a case involving the FDCA and the First Amendment to reach a federal courthouse. Amarin sued the FDA in May of 2015, seeking to expand its approved drug claims to include claims being asserted by dietary supplement manufacturers for the same product. The court in Amarin flatly rejected the position the FDA has been touting for decades— that it was not prosecuting speech but conduct that is evidence of intent. The court went on to hold that "the FDA may not bring such an action based on truthful promotional speech alone, consistent with the First Amendment." (Slip Opinion at 48). The court further rejected the government's attempt to rewrite the holding in Caronia: "Where the speech at issue consists of truthful and non-misleading speech promoting the off-label use of an FDA-approved drug, such speech, under Caronia, cannot be the act upon which an action for misbranding is based." (Id. at 49)

Pacira v. FDA: Declaring The Truth False And Punishing It.

Pacira v US, 15-cv-7055-RA, (SDNY filed on Sept. 9, 2015) adds no new constitutional analysis, but what it does bring is unique facts boasting: "Pacira's case is even stronger, for while the speech at issue in Amarin and Caronia concerned "off-label" drug uses, the speech Pacira desires to engage in concerns on-label information about use of EXPAREL for its FDA-approved indication." (Brief at 1). Pacira's drug EXPAREL was indicated for general surgical use because "[a]s recognized by FDA's historical practice and regulatory guidance ... the safety and effectiveness of EXPAREL in these two well-established pain models provide a clear scientific and medical rationale for concluding that the drug's clinical benefits are generalizable to other surgical sites." (Brief at 2). The FDA-approved label did not limit the types of surgeries to those in the underlying studies. But, through its criminal enforcement power, three years after approval, FDA sought to rewrite the label to limit the indications to the two surgeries studied.

On September 22, 2014, the Company received a Warning Letter from FDA's Office of Prescription Drug Promotion objecting to the company's promotional materials and asserting a violation of the criminal provisions of the FDCA. In the FDA's defense, the Warning Letter (here) states that the clinical trial section of the label states "EXPAREL has not been demonstrated to be safe and effective in other procedures."

In response, the company tried to meet with the FDA to work out how to comply with the FDA's demands due to the fact that the indications section of the labeling did not limit the product to the surgeries studied. More importantly, the product was effective and the incidence of adverse events was low (one third of one tenth percent), but the FDA stonewalled. Given the threat of criminal sanctions, the company relented and did what the FDA demanded and refrained from disseminating truthful FDA-approved information to physicians. The FDA subsequently issued a "Close Out Letter" and Pacira continues to refrain from engaging in conduct that the FDA is barred by the First Amendment from prohibiting.

Not Commercial Speech

Pacira correctly observes that the FDA's interpretation of the regulations broadly defines the term "labeling" to include any utterance (and non-utterance) that supports the FDA's conclusion and the "FDA's interpretation of 'false or misleading' does not hinge on whether information is true." (Brief at 10). One difference in Pacira, unlike Amarin, the manufacturer is not conceding that the speech at issue is commercial speech. This is no minor technicality because where the manufacturer does not concede that the speech at issue is commercial speech and suggests that heightened scrutiny applies. The burden on the government to justify its restriction on speech is much greater when the manufacturer does not concede that intermediate scrutiny for commercial speech applies.

The FDA and Science Fiction

Pacira complains that FDA tramples the First Amendment, imposing two impermissible distinct speaker- and content-based restrictions on Pacira's ability to speak about EXPAREL. The issue for the court is whether the FDA's threatened enforcement of Pacira for discussing the use of EXPAREL in general surgeries and prohibiting statements about the drug's effectiveness runs afoul of the constraints of the First Amendment. Moreover, the FDA's position in its Warning Letter suggests that the FDA may be changing the rules to suit its purpose raising significant due process concerns. For the FDA to prevail, the court may need to agree with the FDA that "as a categorical matter . . . all claims regarding efficacy or comparative claims are false or misleading unless supported by two clinical trials, as FDA purports to do." (Brief at 9).

Before the regulatory ship sinks entirely, FDA might consider following through with what it said it would do: hold public hearings and get the reasoned voice of industry, the public, and even the public interest groups to provide guidance on what has become a public health imperative to provide more, not less, truthful scientific and medical information to the medical community and the public concerning approved products.

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
Michael A. Walsh
Katherine McGahey
Similar Articles
Relevancy Powered by MondaqAI
Proskauer Rose LLP
 
In association with
Related Topics
 
Similar Articles
Relevancy Powered by MondaqAI
Proskauer Rose LLP
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