First Amendment Decision on Off-Label Promotion Will Not Stop FDA (EyeforPharma)
The recent decision to overturn the conviction of sales rep Alfred Caronia for off-label promotion of the narcolepsy drug Xyrem may not be as much of a game-changer as was previously assumed.
The decision, taken by the Court of Appeals for the Second Circuit in Manhattan which recognised the representative’s first amendment right to discuss off-label uses (as long as they are not false or misleading), was touted by many as the first step towards the legalisation of off-label promotion. However, as this Forbes article has noted, the FDA may simply change its line of attack, focussing less on the “promotion” of off-label uses and more on charges of “misbranding”.
Free speech is protected by the First Amendment, and as Caronia pointed out in court off-label uses for drugs such as Xyrem are legally able to be discussed among physicians, and between physicians and their patients. Caronia appealed on the basis that he was being prosecuted for his speech, and that this was a violation of his constitutional rights. However, despite vacating Caronia’s conviction, the court’s opinion indicated that statements by...
