Second Circuit Says First Amendment Shields Sales Rep’s Promotion of a Prescription Drug for Off-Label Use (that is, a use not approved by the FDA)

by Brian Wolfman

The FDA says it violates federal law for a drug company sales rep to promote a prescription drug for an off-label use (that is, a use not approved by the FDA). So, a rep is convicted of a misdemeanor in federal district court for promoting a prescription drug for an off-label use. But in United States of America v. Caronia, the Second Circuit has just held 2-to-1 that the rep "was convicted for his speech," which the First Amendment prohibits, and so it reversed the conviction. The majority stressed that the off-label use itself was lawful. David Lazarus criticizes the decision here.

Here's the beignning of the Second Circuit's opinion:

Defendant-appellant Alfred Caronia appeals from a judgment of conviction entered in the United States District Court for the Eastern District of New York (Eric N. Vitaliano, J.) on November 30, 2009, following a jury trial at which Caronia was found guilty of conspiracy to introduce a misbranded drug into interstate commerce, a misdemeanor violation of 21 U.S.C. §§ 331(a) and 333(a)(1). Specifically, Caronia, a pharmaceutical sales representative, promoted the drug Xyrem for "off-label use," that is, for a purpose not approved by the U.S. Food and Drug Administration (the "FDA"). Caronia argues that he was convicted for his speech — for promoting an FDA-approved drug for off-label use — in violation of his right of free speech under the First Amendment. We agree.


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