Fighting for Freedom of Speech

We are all aware of freedom of speech – the right to communicate our opinions without fear of government retaliation and censorship, but how far does this apply when it comes to off-label drug promotion? The FDA has a duty to ensure that drugs are only marketed for their approved indications and frequently rebukes companies for off-label promotion and misbranding. But some companies are fighting back, claiming that preventing them from talking about off-label use is imposing upon their right to freedom of speech, which is protected in the US by the First Amendment. In August, a federal judge in Manhattan ruled that the FDA could not prevent Amarin from promoting Vacepta for unapproved indications, providing that any information disseminated by Amarin was truthful (1). Off-label use of a drug isn’t illegal in the US, but it is usually considered illegal to actively promote a drug for off-label use.

Vacepta is approved for patients with very high levels of triglyceride in their blood, which can lead to heart problems. It is also sometimes prescribed off-label for patients with lower triglyceride levels. Amarin conducted a study and sought to officially expand the use of the drug, but was blocked by a Complete Response Letter from the FDA. Unhappy with the outcome, Amarin filed for a lawsuit. Delivering the verdict in August, the judge ruled that Amarin was protected from FDA enforcement providing that the off-label statements are truthful; however, the First Amendment would not offer protection from any false or misleading claims. This isn’t the first time that drug promotion has been defended by freedom of speech legislation. In 2012, a court case focused on a sales rep who had been recorded giving a speech promoting off-label use of a narcolepsy drug. The court ruled that providing the sales rep’s speech was truthful, it was protected under the First Amendment. Following on from the Amarin ruling, Pacira Pharmaceuticals filed a lawsuit in early September looking to promote its post-surgery pain relief drug Exparel for a wider range of patients (2). Exparel is approved for pain relief in bunionectomies and hemorrhoidectomies, but the company has been promoting the drug for other kinds of surgeries – and received a warning letter in September 2014 for doing so. In its lawsuit, Pacira contends that all of its marketing claims are actually on-label, but adds that even if they weren’t, the Amarin ruling would apply to their case.

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