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The Enforceability of FDA's Off-Label Marketing Restrictions Following the Amarin Decision

February 17, 2016

By: Yune D. Emeritz

Today (2/17/2016) the American Health Lawyer's Association's (AHLA) Journal of Health & Life Sciences published as its “Featured Article” our analysis of the enforceability of FDA’s off-label marketing restrictions in the aftermath of the August 2015 Amarin Pharma, Inc. v. United States FDA decision. The article, titled, “To Promote or Not to Promote? The Enforceability of FDA’s Off-Label Marketing Restrictions Following Amarin,” traces the recent string of judicial decisions challenging the government’s restrictions on drug companies’ truthful and non-misleading off-label speech as violating the First Amendment’s free speech protections. We also analyze how prior decisions laid the foundation for the Amarin decision, which expressly prohibited a criminal prosecution under the Federal Food Drug and Cosmetic Act for such truthful speech. 

We note that despite Amarin’s historic victory, whether practical, evidentiary and legal considerations counsel continued caution as regards off-label promotion, at least for the time being, remains a live issue. We present a detailed analysis of Amarin and its likely practical impact on pharmaceutical companies and physicians, and the attorneys who represent them.

A link to the abstract and title page are available here. The full version of the article is available to AHLA members here. For non-AHLA members who are interested in reading the full article, please reach out to us via email at or

Disclaimer: This post does not offer specific legal advice, nor does it create an attorney-client relationship. You should not reach any legal conclusions based on the information contained in this post without first seeking the advice of counsel.

About the Authors:

Matt Newcomer 

Matthew T. Newcomer is a Principal in Post & Schell's Internal Investigations & White Collar Defense Practice Groups. Mr. Newcomer conducts internal investigations and counsels and defends corporations, officers and other individuals facing civil and criminal investigation, including matters involving multinational pharmaceutical and medical device companies and exposures concerning off-label sales and marketing practices, the Anti-Kickback Statute (AKS), the “Responsible Corporate Officer” or “Park” doctrine, the federal False Claims Act (FCA) and federal and state RICO statutes. Learn More >>

<a  data-cke-saved-href= Yune T. Do is an Associate in the Firm's Internal Investigations & White Collar Defense Practice Group. She represents and counsels boards, management and employees with government investigations and assists in the defense of clients in related litigation and at trial. This includes allegations of fraud or other misconduct at all stages of the government enforcement cycle, including conducting pre-enforcement internal investigations. Learn More >>