BioCentury
ARTICLE | Politics, Policy & Law

Free speech, in theory

A federal court's rebuke to FDA in Caronia won't unleash off-label marketing

December 10, 2012 8:00 AM UTC

A federal appeals court's decision to overturn the criminal conviction of a pharmaceutical salesman for promoting off-label uses of an FDA-approved drug is, at least in the short term, far less consequential than media coverage suggests. But it may signal the agency and Congress will have to accept less FDA regulation of speech.

The U.S. Court of Appeals for the Second Circuit last week ruled inU.S. v. Caronia that the government's prosecution of Alfred Caronia for statements he made while selling Xyrem sodium oxybate to a physician violated his free speech rights under the First Amendment to the U.S. Constitution...