Second Circuit -- United States v. Caronia

First Amendment protects pharmaceutical reps who advocate off-label uses of the drugs.

Narrowing construction of the statute - FDCA doesn't apply to marketing statements. 

Doesn't work under strict scrutiny or intermediate -- criminalizing reps' representations does nothing if anyone else can make the same representations.

Dissent -- speech was merely evidence of motive.  Demonstrates objective intent to violate statute.

United States v. Caronia