Amarin Pharma, Inc. has filed a proactive First Amendment suit against the FDA regarding the enforcement of the prohibition of off-label promotion that may end up with huge implications for medical device makers.
Challenging Truthful Off-Label Promotion Prohibition
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“Truthful and Factual” Information
On May 7, 2015, Amarin and four physicians, Drs. Jonathan Herbst, Eric Rishe, Peter Gottesfeld and Ralph Yung, filed suit to claim their right to provide “truthful and factual” information to physicians about unapproved uses for Amarin’s Vascepa product. The company says that providing truthful factual information to physicians about unapproved uses for a drug [or device] should be protected free speech under the First Amendment.
They claim that educating physicians will expand available treatments for patients, and be beneficial to the overall health of those patients.
Continued Prosecutions
The FDA and Department of Justice are both still actively enforcing the prohibition of off-label, but truthful promotion through a combination of administrative, civil and, in some cases, criminal enforcement. This system, says the company and doctors, operates to keep doctors and their patients in the dark about all of the options for drugs and devices they are legally empowered to prescribe.
According to the company, this complaint asks the Court to hold that FDA’s prohibitions on “off-label” promotion, as applied to the truthful and non-misleading speech the company wishes to make, “are unconstitutional under the First Amendment, ” and to declare that Amarin may engage in its proposed speech about Vascepa. Such a holding falls squarely within the 2012 Second Circuit Caronia precedent, where the Court reversed, on First Amendment grounds, a criminal conviction of a sales rep based on truthful and non-misleading off-label promotion.
This case is the first time a drug or device maker has not waited to defend itself against prosecution, but proactively get a court to declare their right to exercise their First Amendment rights.
This case will be worth watching.
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Discussion
This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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