Home About RSS

Law and Biosciences Blog
Law and Biosciences Blog

The FDA, Off-Label Use, and the First Amendment: A Conversation with Richard Epstein

Tuesday, January 15

2:00 – 3:00 PM

Stanford Law School Room 280A

Before a drug can be sold legally in the United States, the FDA must approve it as safe and effective for a particular indication — the indication that then appears on the drug’s label. Federal law, however, allows doctors to prescribe drugs that the FDA has approved for one indication for any otherwise legal purpose, even though the FDA never passed on the safety or efficacy of the drug for that use. This kind of “off-label use” is very common and completely legal, but federal law forbids drug companies from promoting their products for such off-label uses, apart from some limited safe harbors. Civil and criminal actions against drug companies for illegal promotion for off-label use have proliferated in recent years, leading to many large settlements.  In United States v. Caronia, however, a divided Second Circuit panel recently ruled that the conviction of a drug marketing rep for off-label promotion violated the rep’s First Amendment free speech rights.

Richard Epstein, the Laurence A. Tisch Professor of Law at NYU and the Kirsten Bedford Senior Fellow at the Hoover Institution, has suggested courts should strike down not only the ban on off-label promotion, but (absent false or misleading information) all laws barring the sale of prescription drugs. See http://www.hoover.org/publications/defining-ideas/article/136416.

The Stanford Center for Law and the Biosciences is happy to sponsor a discussion with Professor Epstein about the Caronia decision and, more generally, the future of drug regulation.

This event is free and open to the public.

Leave a Reply