FDA Law Blog: Drug Promotion in the 21st Century: Off-label Marketing and First Amendment Concerns

FDA Law Blog: Drug Promotion in the 21st Century: Off-label Marketing and First Amendment Concerns

Drug Promotion in the 21st Century: Off-label Marketing and First Amendment Concerns

Posted: 23 Mar 2016 04:51 AM PDT

On March 31, 2016, from 10:00 AM - 12:30 PM, the American University Washington College of Law (Washington, D.C.) will hold a symposium to discuss recent developments in off-label promotion, including the recent Amarin case (see our previous posthere).   The symposium, titled “Drug Promotion in the 21st Century: Off-label Marketing and First Amendment Concerns,” will be moderated by Lewis A. Grossman J.D., Ph.D., Professor of Law at American University’s Washington College of Law, and includes a stellar cast of panelists.

Here’s a description of the symposium from the event flyer:

Although FDA approves drugs for specific medical purposes, many treatments approved for one use are also effective for other diseases and conditions.  The FDA has traditionally prohibited the promotion of medical products for uses other than those approved by the agency and reflected in the labeling.  This restriction, however, has recently been weakened by successful legal challenges based on the First Amendment guarantee of freedom of speech.  This event will provide an overview of these issues and assess recent legal developments, including several important cases decided in the past few months.  The panelists will also consider the implications of this expanding right to off‑label promotion for the FDA, the drug industry, and medical practice.

Registration for the symposium is free but required.  You can register here.  Lunch will be served