United States v. Caronia

Defendant appealed from a conviction of conspiracy to introduce a misbranded drug into interstate commerce, a misdemeanor violation of 21 U.S.C. 331(a) and 333(a)(1). Defendant, a pharmaceutical sales representative, promoted the drug Xyrem for "off-label use." The court agreed with defendant 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. The court limited its holding to FDA-approved drugs for which off-label use was not prohibited. Accordingly, the court vacated and remanded. View "United States v. Caronia" on Justia Law