First Amendment Prohibits Criminal Prosecution of Truthful Off-Label Promotion

by Morgan Lewis

[authors: Erica Smith-Klocek, Brian W. Shaffer, and Chelsea C. Stine]

Second Circuit holds that the government will be required to prove more than simple off-label promotion for misbranding prosecutions under the FDCA.

On December 3, the U.S. Court of Appeals for the Second Circuit ruled in a highly anticipated, divided (2-1) panel decision that truthful, non-misleading speech by pharmaceutical manufacturers and their sales representatives promoting the off-label use of medications approved by the U.S. Food and Drug Administration (FDA) is protected from criminal prosecution by the Free Speech Clause of the First Amendment. The panel's decision in United States v. Caronia[1] vacated and remanded the federal conviction of Jazz Pharmaceuticals sales representative Alfred Caronia for conspiracy to introduce a misbranded drug into interstate commerce—a misdemeanor violation of the federal Food, Drug, and Cosmetic Act (FDCA). Finding that the prohibition and criminalization of a pharmaceutical manufacturer's truthful speech promoting off-label use would violate the First Amendment, the majority applied the principle of "constitutional avoidance" in deciding that the FDCA does not prohibit such speech. In doing so, the Second Circuit now requires that the government prove more than simple off-label promotion for misbranding prosecutions under the FDCA.


Under the FDCA's regulatory scheme, which requires that a prescription drug be approved by the FDA for specific uses before a manufacturer may introduce the drug into interstate commerce, physicians may lawfully prescribe, and patients may lawfully use, prescription medicines for uses not approved by the FDA ("off label"). However, the FDCA makes it a criminal offense to introduce "into interstate commerce . . . any . . . drug . . . that is . . . misbranded." Under the FDCA, a drug is "misbranded" if its labeling fails to bear "adequate directions for use," meaning, directions under which a drug can be used safely for the purposes for which it is intended. Although the FDCA does not expressly prohibit off-label marketing, the majority stated that the government had "construed the FDCA to prohibit promotional speech as misbranding itself."[2]

In 2005, Caronia was tape-recorded by a government informant, on two occasions, promoting the off-label use of Xyrem. Xyrem was a medication approved by the FDA for the treatment of a limited number of narcolepsy symptoms; however, the informant's recording captured Caronia marketing the drug for both "unapproved indications and unapproved subpopulations."[3] Caronia was subsequently charged with two misdemeanor violations of the FDCA: conspiracy to introduce a misbranded drug into interstate commerce and introducing a misbranded drug into interstate commerce. In 2008, the U.S. District Court for the Eastern District of New York denied Caronia's motion to dismiss, in which he argued that his conduct was protected by the First Amendment. At trial, the district court instructed the jury that a drug "'manufacturer, its agents, representatives and employees, are not permitted to promote uses for a drug that have not been cleared by the [FDA].'"[4] The jury returned a conviction under the conspiracy charge and Caronia was sentenced to a one-year term of probation and 100 hours of community service.

Second Circuit's Majority Decision

In attempting to uphold the conviction, the government first urged on appeal that the First Amendment was not implicated in the conviction, claiming Caronia's speech promoting the off-label uses of Xyrem was only used as evidence of the intended use of the medication, rather than serving as the basis of the conviction itself. But Judge Denny Chin, writing for the majority, rejected this argument outright based on the trial court record, citing passages where the government "repeatedly argued that Caronia engaged in criminal conduct by promoting and marketing the off-label use" of the medication. The court held that the record made "clear that the government prosecuted Caronia for his promotion and marketing efforts."[5]

Moving on, the court held that the FDCA does not criminalize the "simple promotion of a drug's off-label use because such a construction would raise First Amendment concerns."[6] Relying heavily on the U.S. Supreme Court's 2011 decision in Sorrell v. IMS Health, Inc.,[7] which held unconstitutional on First Amendment grounds a Vermont regulation prohibiting pharmaceutical companies from using prescriber-identifying information for marketing purposes, the majority found that the prohibition of off-label marketing was both content based, because the express purpose was to diminish the effectiveness of off-label drug marketing by manufacturers, and speaker based, because it targeted only drug manufacturers. Accordingly, the Second Circuit found that the limitations of off-label promotional statements would be subject to heightened scrutiny under Sorrell as applied to content- and speaker-based speech limitations.

Ultimately, the court held that the FDCA construction urged by the government could not pass such heightened scrutiny. First, it found that, because off-label drug use is lawful, promotion of off-label drug use—provided it is not false and misleading—concerns lawful activity. Second, it found that the government's asserted interests in drug safety and public health are substantial. Third, it found that, because off-label drug use itself is not prohibited, the government's prohibition of off-label promotion did not "directly further the government's goals of preserving the efficacy and integrity of the FDA's drug approval process and reducing patient exposure to unsafe and ineffective drugs."[8] The majority noted that, in fact, "interfer[ing] with the ability of physicians and patients to receive potentially relevant treatment information . . . could inhibit, to the public's detriment, informed and intelligent treatment decisions."[9] Fourth, the majority found that "the government's construction of the FDCA to impose a complete and criminal ban on off-label promotion by pharmaceutical manufacturers is more extensive than necessary to achieve the government's substantial interests" and proposed a variety of possible alternatives.[10] Thus, the court concluded that the misbranding provisions of the FDCA neither prohibit nor criminalize the truthful off-label promotion of FDA-approved prescription drugs.


In dissent, Judge Debra Ann Livingston disagreed that the government prosecuted Caronia for his speech alone and argued that she would confirm his conviction because the First Amendment "has never prohibited the government from using speech as evidence of motive or intent." The majority's decision, she stated, "calls into question the very foundations of our century-old system of drug regulation."[11] Judge Livingston urged that, even if offering Caronia's speech as evidence of intent implicates the First Amendment, application of the FDCA's misbranding provision to Caronia's case survived heightened scrutiny. First, she argued that the prohibition on off-label promotion directly advances a substantial government interest because, if drug manufacturers were allowed to promote FDA-approved drugs for non-approved uses, they would have little incentive to seek FDA approval for those uses because any substance that may be legally sold for some purposes may then be promoted by its manufacturer for any purpose—so long as the manufacturer's statements are merely unsubstantiated, rather than demonstrably false or misleading. Second, she argued that the prohibition was also the least restrictive way of advancing the government's interests. Criticizing the majority's proposed less-restrictive alternatives, Judge Livingston posited that permitting manufacturers to engage in off-label promotion undermined the FDCA's entire scheme of drug regulation.


The government and others who seek to bring legal action against drug manufacturers based on alleged off-label promotion are likely to argue that the Second Circuit's decision is limited in scope. Indeed, the majority acknowledged that speech can properly be used as evidence in a criminal prosecution but did not reach the question of whether the First Amendment would have barred Caronia's conviction had the government's prosecution and the district court's jury instructions limited the evidence of Caronia's off-label marketing to prove the element of intent for the misbranding charge.

The decision is nonetheless significant for several reasons. Most notably, it draws an important distinction between off-label marketing and misbranding and thus requires the government to prove something more than mere off-label promotion—such as proof that the off-label promotion was false or misleading—in order to obtain a criminal misbranding conviction. In fact, in its briefing, the government conceded that "[p]romoting an approved drug for off-label uses is not itself a prohibited act under the FDCA."

In addition, the decision is a significant recognition that off-label promotion is protected commercial speech—the regulation, penalization, or punishment of which may be subject to heightened scrutiny. It is also an express acknowledgment by a leading appellate court that (a) the FDCA does not expressly prohibit off-label promotion, (b) off-label drug use and prescribing are lawful, and (c) the government's construed prohibition applies only to manufacturers and their employees and not other actors, such as physicians or academics. While these are generally well-recognized principles, only a few courts to date have acknowledged them in published decisions.

Whether this decision will spark a broader change in FDA policy is yet to be seen, as we suspect the court's decision is far from final. A rehearing en banc, or a petition for certiorari to the U.S. Supreme Court, is a possible next step. In the interim, however, manufacturers have a new basis for arguing that government efforts to pursue pharmaceutical companies for truthful off-label promotion are overreaching and improper.

Morgan Lewis's White Collar Practice

Morgan Lewis's national and international White Collar Practice features dozens of former prosecutors and former high-level government officials whose experience representing companies and individuals covers a broad array of substantive white collar and government enforcement areas, including, among others:

  • Antitrust
  • Congressional investigations
  • Environmental
  • False Claims Act
  • FCPA
  • Financial fraud
  • Healthcare fraud
  • Industrial accidents and workplace safety
  • Import/export regulations
  • Money laundering
  • Qui tam
  • Securities fraud/SEC enforcement
  • Tax

If you have any questions regarding this LawFlash, or require assistance with any issue relating to the defense of a government enforcement matter, please contact any of the authors, Erica Smith-Klocek (215.963.5364;, Brian W. Shaffer (215.963.5103;, or Chelsea C. Stine (215.963.5498;

[1]. United States v. Caronia, No. 09-5006-cr, 2012 WL 5992141 (2d Cir. Dec. 3, 2012), available here.

[2]. Id. at *3.

[3]. Id. at *4.

[4]. Id. at *7.

[5]. Id. at *9.

[6]. Id. at *8.

[7]. Sorrell v. IMS Health, Inc., 131 S. Ct. 2653, 180 L. Ed. 2d 544 (2011).

[8]. Caronia, 2012 WL 5992141, at *13.

[9]. Id.

[10]. Id. at *14.

[11]. Id. at *15 (Livingston, J., dissenting).


DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© Morgan Lewis | Attorney Advertising

Written by:

Morgan Lewis

Morgan Lewis on:

Readers' Choice 2017
Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Custom Email Digest
- hide

JD Supra Privacy Policy

Updated: May 25, 2018:

JD Supra is a legal publishing service that connects experts and their content with broader audiences of professionals, journalists and associations.

This Privacy Policy describes how JD Supra, LLC ("JD Supra" or "we," "us," or "our") collects, uses and shares personal data collected from visitors to our website (located at (our "Website") who view only publicly-available content as well as subscribers to our services (such as our email digests or author tools)(our "Services"). By using our Website and registering for one of our Services, you are agreeing to the terms of this Privacy Policy.

Please note that if you subscribe to one of our Services, you can make choices about how we collect, use and share your information through our Privacy Center under the "My Account" dashboard (available if you are logged into your JD Supra account).

Collection of Information

Registration Information. When you register with JD Supra for our Website and Services, either as an author or as a subscriber, you will be asked to provide identifying information to create your JD Supra account ("Registration Data"), such as your:

  • Email
  • First Name
  • Last Name
  • Company Name
  • Company Industry
  • Title
  • Country

Other Information: We also collect other information you may voluntarily provide. This may include content you provide for publication. We may also receive your communications with others through our Website and Services (such as contacting an author through our Website) or communications directly with us (such as through email, feedback or other forms or social media). If you are a subscribed user, we will also collect your user preferences, such as the types of articles you would like to read.

Information from third parties (such as, from your employer or LinkedIn): We may also receive information about you from third party sources. For example, your employer may provide your information to us, such as in connection with an article submitted by your employer for publication. If you choose to use LinkedIn to subscribe to our Website and Services, we also collect information related to your LinkedIn account and profile.

Your interactions with our Website and Services: As is true of most websites, we gather certain information automatically. This information includes IP addresses, browser type, Internet service provider (ISP), referring/exit pages, operating system, date/time stamp and clickstream data. We use this information to analyze trends, to administer the Website and our Services, to improve the content and performance of our Website and Services, and to track users' movements around the site. We may also link this automatically-collected data to personal information, for example, to inform authors about who has read their articles. Some of this data is collected through information sent by your web browser. We also use cookies and other tracking technologies to collect this information. To learn more about cookies and other tracking technologies that JD Supra may use on our Website and Services please see our "Cookies Guide" page.

How do we use this information?

We use the information and data we collect principally in order to provide our Website and Services. More specifically, we may use your personal information to:

  • Operate our Website and Services and publish content;
  • Distribute content to you in accordance with your preferences as well as to provide other notifications to you (for example, updates about our policies and terms);
  • Measure readership and usage of the Website and Services;
  • Communicate with you regarding your questions and requests;
  • Authenticate users and to provide for the safety and security of our Website and Services;
  • Conduct research and similar activities to improve our Website and Services; and
  • Comply with our legal and regulatory responsibilities and to enforce our rights.

How is your information shared?

  • Content and other public information (such as an author profile) is shared on our Website and Services, including via email digests and social media feeds, and is accessible to the general public.
  • If you choose to use our Website and Services to communicate directly with a company or individual, such communication may be shared accordingly.
  • Readership information is provided to publishing law firms and authors of content to give them insight into their readership and to help them to improve their content.
  • Our Website may offer you the opportunity to share information through our Website, such as through Facebook's "Like" or Twitter's "Tweet" button. We offer this functionality to help generate interest in our Website and content and to permit you to recommend content to your contacts. You should be aware that sharing through such functionality may result in information being collected by the applicable social media network and possibly being made publicly available (for example, through a search engine). Any such information collection would be subject to such third party social media network's privacy policy.
  • Your information may also be shared to parties who support our business, such as professional advisors as well as web-hosting providers, analytics providers and other information technology providers.
  • Any court, governmental authority, law enforcement agency or other third party where we believe disclosure is necessary to comply with a legal or regulatory obligation, or otherwise to protect our rights, the rights of any third party or individuals' personal safety, or to detect, prevent, or otherwise address fraud, security or safety issues.
  • To our affiliated entities and in connection with the sale, assignment or other transfer of our company or our business.

How We Protect Your Information

JD Supra takes reasonable and appropriate precautions to insure that user information is protected from loss, misuse and unauthorized access, disclosure, alteration and destruction. We restrict access to user information to those individuals who reasonably need access to perform their job functions, such as our third party email service, customer service personnel and technical staff. You should keep in mind that no Internet transmission is ever 100% secure or error-free. Where you use log-in credentials (usernames, passwords) on our Website, please remember that it is your responsibility to safeguard them. If you believe that your log-in credentials have been compromised, please contact us at

Children's Information

Our Website and Services are not directed at children under the age of 16 and we do not knowingly collect personal information from children under the age of 16 through our Website and/or Services. If you have reason to believe that a child under the age of 16 has provided personal information to us, please contact us, and we will endeavor to delete that information from our databases.

Links to Other Websites

Our Website and Services may contain links to other websites. The operators of such other websites may collect information about you, including through cookies or other technologies. If you are using our Website or Services and click a link to another site, you will leave our Website and this Policy will not apply to your use of and activity on those other sites. We encourage you to read the legal notices posted on those sites, including their privacy policies. We are not responsible for the data collection and use practices of such other sites. This Policy applies solely to the information collected in connection with your use of our Website and Services and does not apply to any practices conducted offline or in connection with any other websites.

Information for EU and Swiss Residents

JD Supra's principal place of business is in the United States. By subscribing to our website, you expressly consent to your information being processed in the United States.

  • Our Legal Basis for Processing: Generally, we rely on our legitimate interests in order to process your personal information. For example, we rely on this legal ground if we use your personal information to manage your Registration Data and administer our relationship with you; to deliver our Website and Services; understand and improve our Website and Services; report reader analytics to our authors; to personalize your experience on our Website and Services; and where necessary to protect or defend our or another's rights or property, or to detect, prevent, or otherwise address fraud, security, safety or privacy issues. Please see Article 6(1)(f) of the E.U. General Data Protection Regulation ("GDPR") In addition, there may be other situations where other grounds for processing may exist, such as where processing is a result of legal requirements (GDPR Article 6(1)(c)) or for reasons of public interest (GDPR Article 6(1)(e)). Please see the "Your Rights" section of this Privacy Policy immediately below for more information about how you may request that we limit or refrain from processing your personal information.
  • Your Rights
    • Right of Access/Portability: You can ask to review details about the information we hold about you and how that information has been used and disclosed. Note that we may request to verify your identification before fulfilling your request. You can also request that your personal information is provided to you in a commonly used electronic format so that you can share it with other organizations.
    • Right to Correct Information: You may ask that we make corrections to any information we hold, if you believe such correction to be necessary.
    • Right to Restrict Our Processing or Erasure of Information: You also have the right in certain circumstances to ask us to restrict processing of your personal information or to erase your personal information. Where you have consented to our use of your personal information, you can withdraw your consent at any time.

You can make a request to exercise any of these rights by emailing us at or by writing to us at:

Privacy Officer
JD Supra, LLC
10 Liberty Ship Way, Suite 300
Sausalito, California 94965

You can also manage your profile and subscriptions through our Privacy Center under the "My Account" dashboard.

We will make all practical efforts to respect your wishes. There may be times, however, where we are not able to fulfill your request, for example, if applicable law prohibits our compliance. Please note that JD Supra does not use "automatic decision making" or "profiling" as those terms are defined in the GDPR.

  • Timeframe for retaining your personal information: We will retain your personal information in a form that identifies you only for as long as it serves the purpose(s) for which it was initially collected as stated in this Privacy Policy, or subsequently authorized. We may continue processing your personal information for longer periods, but only for the time and to the extent such processing reasonably serves the purposes of archiving in the public interest, journalism, literature and art, scientific or historical research and statistical analysis, and subject to the protection of this Privacy Policy. For example, if you are an author, your personal information may continue to be published in connection with your article indefinitely. When we have no ongoing legitimate business need to process your personal information, we will either delete or anonymize it, or, if this is not possible (for example, because your personal information has been stored in backup archives), then we will securely store your personal information and isolate it from any further processing until deletion is possible.
  • Onward Transfer to Third Parties: As noted in the "How We Share Your Data" Section above, JD Supra may share your information with third parties. When JD Supra discloses your personal information to third parties, we have ensured that such third parties have either certified under the EU-U.S. or Swiss Privacy Shield Framework and will process all personal data received from EU member states/Switzerland in reliance on the applicable Privacy Shield Framework or that they have been subjected to strict contractual provisions in their contract with us to guarantee an adequate level of data protection for your data.

California Privacy Rights

Pursuant to Section 1798.83 of the California Civil Code, our customers who are California residents have the right to request certain information regarding our disclosure of personal information to third parties for their direct marketing purposes.

You can make a request for this information by emailing us at or by writing to us at:

Privacy Officer
JD Supra, LLC
10 Liberty Ship Way, Suite 300
Sausalito, California 94965

Some browsers have incorporated a Do Not Track (DNT) feature. These features, when turned on, send a signal that you prefer that the website you are visiting not collect and use data regarding your online searching and browsing activities. As there is not yet a common understanding on how to interpret the DNT signal, we currently do not respond to DNT signals on our site.

Access/Correct/Update/Delete Personal Information

For non-EU/Swiss residents, if you would like to know what personal information we have about you, you can send an e-mail to We will be in contact with you (by mail or otherwise) to verify your identity and provide you the information you request. We will respond within 30 days to your request for access to your personal information. In some cases, we may not be able to remove your personal information, in which case we will let you know if we are unable to do so and why. If you would like to correct or update your personal information, you can manage your profile and subscriptions through our Privacy Center under the "My Account" dashboard. If you would like to delete your account or remove your information from our Website and Services, send an e-mail to

Changes in Our Privacy Policy

We reserve the right to change this Privacy Policy at any time. Please refer to the date at the top of this page to determine when this Policy was last revised. Any changes to our Privacy Policy will become effective upon posting of the revised policy on the Website. By continuing to use our Website and Services following such changes, you will be deemed to have agreed to such changes.

Contacting JD Supra

If you have any questions about this Privacy Policy, the practices of this site, your dealings with our Website or Services, or if you would like to change any of the information you have provided to us, please contact us at:

JD Supra Cookie Guide

As with many websites, JD Supra's website (located at (our "Website") and our services (such as our email article digests)(our "Services") use a standard technology called a "cookie" and other similar technologies (such as, pixels and web beacons), which are small data files that are transferred to your computer when you use our Website and Services. These technologies automatically identify your browser whenever you interact with our Website and Services.

How We Use Cookies and Other Tracking Technologies

We use cookies and other tracking technologies to:

  1. Improve the user experience on our Website and Services;
  2. Store the authorization token that users receive when they login to the private areas of our Website. This token is specific to a user's login session and requires a valid username and password to obtain. It is required to access the user's profile information, subscriptions, and analytics;
  3. Track anonymous site usage; and
  4. Permit connectivity with social media networks to permit content sharing.

There are different types of cookies and other technologies used our Website, notably:

  • "Session cookies" - These cookies only last as long as your online session, and disappear from your computer or device when you close your browser (like Internet Explorer, Google Chrome or Safari).
  • "Persistent cookies" - These cookies stay on your computer or device after your browser has been closed and last for a time specified in the cookie. We use persistent cookies when we need to know who you are for more than one browsing session. For example, we use them to remember your preferences for the next time you visit.
  • "Web Beacons/Pixels" - Some of our web pages and emails may also contain small electronic images known as web beacons, clear GIFs or single-pixel GIFs. These images are placed on a web page or email and typically work in conjunction with cookies to collect data. We use these images to identify our users and user behavior, such as counting the number of users who have visited a web page or acted upon one of our email digests.

JD Supra Cookies. We place our own cookies on your computer to track certain information about you while you are using our Website and Services. For example, we place a session cookie on your computer each time you visit our Website. We use these cookies to allow you to log-in to your subscriber account. In addition, through these cookies we are able to collect information about how you use the Website, including what browser you may be using, your IP address, and the URL address you came from upon visiting our Website and the URL you next visit (even if those URLs are not on our Website). We also utilize email web beacons to monitor whether our emails are being delivered and read. We also use these tools to help deliver reader analytics to our authors to give them insight into their readership and help them to improve their content, so that it is most useful for our users.

Analytics/Performance Cookies. JD Supra also uses the following analytic tools to help us analyze the performance of our Website and Services as well as how visitors use our Website and Services:

  • HubSpot - For more information about HubSpot cookies, please visit
  • New Relic - For more information on New Relic cookies, please visit
  • Google Analytics - For more information on Google Analytics cookies, visit To opt-out of being tracked by Google Analytics across all websites visit This will allow you to download and install a Google Analytics cookie-free web browser.

Facebook, Twitter and other Social Network Cookies. Our content pages allow you to share content appearing on our Website and Services to your social media accounts through the "Like," "Tweet," or similar buttons displayed on such pages. To accomplish this Service, we embed code that such third party social networks provide and that we do not control. These buttons know that you are logged in to your social network account and therefore such social networks could also know that you are viewing the JD Supra Website.

Controlling and Deleting Cookies

If you would like to change how a browser uses cookies, including blocking or deleting cookies from the JD Supra Website and Services you can do so by changing the settings in your web browser. To control cookies, most browsers allow you to either accept or reject all cookies, only accept certain types of cookies, or prompt you every time a site wishes to save a cookie. It's also easy to delete cookies that are already saved on your device by a browser.

The processes for controlling and deleting cookies vary depending on which browser you use. To find out how to do so with a particular browser, you can use your browser's "Help" function or alternatively, you can visit which explains, step-by-step, how to control and delete cookies in most browsers.

Updates to This Policy

We may update this cookie policy and our Privacy Policy from time-to-time, particularly as technology changes. You can always check this page for the latest version. We may also notify you of changes to our privacy policy by email.

Contacting JD Supra

If you have any questions about how we use cookies and other tracking technologies, please contact us at:

- hide

This website uses cookies to improve user experience, track anonymous site usage, store authorization tokens and permit sharing on social media networks. By continuing to browse this website you accept the use of cookies. Click here to read more about how we use cookies.