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 sales reps could be taken as examples of the “intended use” of the drug, which, if it does not correspond to what is on the label, would mean that the drug has been “misbranded”. Law firm Hogan Lovellspredicts that “the government is likely to argue that speech has always been admissible to prove motive and intent”. Misbranding of drugs is prohibited by the FDA, and if the sales rep’s speech can be seen as evidence of this, then the First Amendment cannot be used as a defence.
One example of this change of focus, which targets not the promotion of a drug but its intended uses, can be seen in the recent Amgen settlement, where the DOJ stated that “it is illegal for drug companies to introduce into the marketplace drugs that the company intends will be used ‘off-label”. This rephrasing means that the justice department’s ongoing investigations and pending settlements, including an upcoming multi-billion dollar settlement against Johnson & Johnson, are likely to be unaffected by First Amendment concerns.
J&J is on track to pay up to $2.2 billion for civil and criminal charges relating to the off-label marketing of the antipsychotic drug Risperdal, which was promoted for unapproved uses including depression, anxiety, bipolar disorder in children and teenagers, and dementia in elderly patients. The settlement also includes other drugs that were marketed off-label, including Natrecor and Invega.