Is Off-Label Drug Promotion Protected Free Speech?

by Searcy Denney Scarola Barnhart & Shipley

It is a very common practice. Drug sales reps visit a client, usually a hospital, a clinic or a doctor, with the sole purpose of selling a drug or medical device. That is the primary way a doctor learns about a drug or device, but it is fraught with problems.

The Washington Post asks the question “Should a pharmaceutical sales rep be allowed to tell a doctor that Topamax, prescribed for migraines and seizures, might also work on alcohol addiction?” Is it his free speech right to say that any drug has uses beyond what’s listed on its label? Historically, the answer to that question has been no.

Doctors have been allowed to prescribe off-label but the drug industry has not been allowed to advertise use of a drug for which it was not approved. To do so could be considered Medicare fraud, deceptive practices, misbranding and a violation of consumer protection laws.

Courtesy of Housed.But misbranding has become increasingly common. Consider the case of Risperdal, the Johnson & Johnson (Janssen Pharmaceuticals) antipsychotic drug approved to treat schizophrenia and a bi-polar condition.  But the drug was routinely prescribed to keep quiet dementia patients in nursing homes, mentally challenged youths or disabled individuals. The known side effects include heart complications and stroke and Risperdal posed a substantial risk of death, particularly in the elderly.

That didn’t stop Johnson & Johnson from promoting those uses - and in many cases, Medicare paid.

As a result, the Department of Justice fined J&J $2.2 billion for off-label marketing. It’s not all bad news for J&J. At the end of the day, Risperdal brought more in profits than fines.

Prompted in part by some recent court decisions, the Food and Drug Administration (FDA) plans to set some new guidelines by the end of the year to clarify what sort of data drug companies will be allowed to disclose to physicians.  The drug industry had argued it was their First Amendment right of free speech to tell physicians about the off-label uses of their drugs, as long as it is truthful. However, fatalities resulted when that happened with Risperdal when it was promoted for off-label use.

Suffice it to say the FDA has had no consistent policy prohibiting the off-label speech and promotion concerning drugs and devices.

GlaxoSmithKline also paid about $3 billion for mislabeling its popular antidepressants off-label. Vioxx was promoted as a treatment for rheumatoid arthritis, for which it was not approved. The drug was found to increase the risks of heart attacks and was linked to at least 55,000 deaths before it was recalled. In the end, the profits derived exceeded the fines.

Medicare even pays for some drugs prescribed off-label.

How can the FDA protect Americans if industry reps can urge the use of untested practices? The truth is that without rules and penalties, the FDA cannot protect Americans from off-label use of drugs. In order to be labeled and approved, a drug must undergo clinical trials and premarket approval to prove safety and efficacy. Off-label use has not undergone any such testing, so how is the FDA protecting Americans and fulfilling its role as a watchdog?

Is Off-Label Drug Promotion Protected Free Speech?

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.

© Searcy Denney Scarola Barnhart & Shipley | Attorney Advertising

Written by:

Searcy Denney Scarola Barnhart & Shipley

Searcy Denney Scarola Barnhart & Shipley 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:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Custom Email Digest
Privacy Policy (Updated: October 8, 2015):

JD Supra provides users with access to its legal industry publishing services (the "Service") through its website (the "Website") as well as through other sources. Our policies with regard to data collection and use of personal information of users of the Service, regardless of the manner in which users access the Service, and visitors to the Website are set forth in this statement ("Policy"). By using the Service, you signify your acceptance of this Policy.

Information Collection and Use by JD Supra

JD Supra collects users' names, companies, titles, e-mail address and industry. JD Supra also tracks the pages that users visit, logs IP addresses and aggregates non-personally identifiable user data and browser type. This data is gathered using cookies and other technologies.

The information and data collected is used to authenticate users and to send notifications relating to the Service, including email alerts to which users have subscribed; to manage the Service and Website, to improve the Service and to customize the user's experience. This information is also provided to the authors of the content to give them insight into their readership and help them to improve their content, so that it is most useful for our users.

JD Supra does not sell, rent or otherwise provide your details to third parties, other than to the authors of the content on JD Supra.

If you prefer not to enable cookies, you may change your browser settings to disable cookies; however, please note that rejecting cookies while visiting the Website may result in certain parts of the Website not operating correctly or as efficiently as if cookies were allowed.

Email Choice/Opt-out

Users who opt in to receive emails may choose to no longer receive e-mail updates and newsletters by selecting the "opt-out of future email" option in the email they receive from JD Supra or in their JD Supra account management screen.


JD Supra takes reasonable precautions to insure that user information is kept private. 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. However, please note that no method of transmitting or storing data is completely secure and we cannot guarantee the security of user information. Unauthorized entry or use, hardware or software failure, and other factors may compromise the security of user information at any time.

If you have reason to believe that your interaction with us is no longer secure, you must immediately notify us of the problem by contacting us at In the unlikely event that we believe that the security of your user information in our possession or control may have been compromised, we may seek to notify you of that development and, if so, will endeavor to do so as promptly as practicable under the circumstances.

Sharing and Disclosure of Information JD Supra Collects

Except as otherwise described in this privacy statement, JD Supra will not disclose personal information to any third party unless we believe that disclosure is necessary to: (1) comply with applicable laws; (2) respond to governmental inquiries or requests; (3) comply with valid legal process; (4) protect the rights, privacy, safety or property of JD Supra, users of the Service, Website visitors or the public; (5) permit us to pursue available remedies or limit the damages that we may sustain; and (6) enforce our Terms & Conditions of Use.

In the event there is a change in the corporate structure of JD Supra such as, but not limited to, merger, consolidation, sale, liquidation or transfer of substantial assets, JD Supra may, in its sole discretion, transfer, sell or assign information collected on and through the Service to one or more affiliated or unaffiliated third parties.

Links to Other Websites

This Website and the Service may contain links to other websites. The operator of such other websites may collect information about you, including through cookies or other technologies. If you are using the Service through the Website and link to another site, you will leave the 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 shall have no responsibility or liability for your visitation to, and the data collection and use practices of, such other sites. This Policy applies solely to the information collected in connection with your use of this Website and does not apply to any practices conducted offline or in connection with any other websites.

Changes in Our Privacy Policy

We reserve the right to change this 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 the Service or Website following such changes, you will be deemed to have agreed to such changes. If you do not agree with the terms of this Policy, as it may be amended from time to time, in whole or part, please do not continue using the Service or the Website.

Contacting JD Supra

If you have any questions about this privacy statement, the practices of this site, your dealings with this Web site, or if you would like to change any of the information you have provided to us, please contact us at:

- hide
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.