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 arti...