News & Insights


Criminal Punishment for Telling the Truth: Off-Label Promotion and the First Amendment

Program Speakers

Jeffrey S. Bucholtz, Lisa M. Dwyer, and John C. Richter


The Department of Justice aggressively prosecutes manufacturers who promote FDA-approved drugs or medical devices for off-label uses. The government's stance raises serious First Amendment questions that the government has largely managed to avoid by extracting onerous settlements from manufacturers. Until now, that is. The Southern District of New York recently granted a pharmaceutical manufacturer's request for a declaration that the First Amendment precludes the government from imposing criminal liability for truthful speech about off-label uses. The same issue is presented in other pending cases. This presentation will explore the recent developments in this area and offer guidance about how to mount successful First Amendment challenges to the government's off-label promotion regime.

You may register for the program here.

If you have questions that are not addressed during the program, please contact one of the speakers and they will be happy to answer them.

If you would like to receive CLE credit for this program, please complete this linked form and return to King & Spalding (see instructions on form).

Thank you for your interest in our e-Learn Series.  To send a request to have your name placed on the e-Learn invitation list, click here


Glenda R. Smith
Senior Paralegal

King & Spalding LLP
1180 Peachtree Street NE
Atlanta, GA 30309
+1 404 572 3017 Direct

Event Details

Date: December 10, 2015