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COMMENT: What does Amarin’s off-patent victory over the FDA mean for the industry?

Published on 14/03/16 at 01:08pm

Last week, reported that small biopharma Amarin had settled litigation with US drugs regulator the FDA that will allow it to market triglyceride-lowering drug Vascepa (icosapent ethyl) off label.

In reaching an agreement with the FDA, Amarin now has the right to promote the drug for uses for which it is not formally approved by the FDA – a potentially significant outcome for the pharma industry.


Amarin’s fish-oil- based drug Vascepa was approved by the FDA in July 2012 to treat a lipid disorder causing very high levels of triglycerides – a condition linked to obesity and diabetes called hypertriglyceridemia. This approval, based on results from a single late-stage trial, was rather narrower than Amarin had hoped for, as study data also suggested the drug could help lower persistently high triglyceride levels and prevent adverse cardiovascular events, but the FDA did not approve in these additional indications, and warned the drugmaker not to promote Vascepa for them, saying this could be considered a violation of the Food, Drug, and Cosmetic Act (FDCA).

Last year, Amarin brought an injunction against the FDA, arguing that in US law, the First Amendment prevents the FDA from stopping it discussing additional uses of Vacepa based on its trial findings, on the basis of truthful free speech.

In August 2015, a US District Court granted this injunction, agreeing that the drugs regulator could not stop Amarin from promoting Vascepa to doctors for off-label uses, provided what it told them was “truthful and non-misleading” This could mean the company telling the doctors about ongoing clinical trials supporting the drug’s use in other indications.

Last week, Amarin reported that the FDA had decided not to appeal the court’s verdict, and that the two had reached a settlement.

What this means

The FDA played down the significance of the case, telling the media the settlement was specific to the particular case and did not signify its position on the First Amendment and commercial speech more broadly.

But lawyers have described the case as the most significant case relating to FDA regulation of off-label speech since Orphan Medical and Xyrem – the US v Caronia case where a company sales rep was convicted for promoting the off-label use of the drug to doctors. This decision was later overturned on appeal, with the three-judge panel ruling 2-1 in favour of Caronia, the sales rep in question.

The dissenting judge, Debra Ann Livingston, argued at the time that the decision “calls into question the very foundations of our century-old system of drug regulation,” adding that if drugmakers were allowed to promote FDA-approved drugs for non-approved uses, “they would have little incentive to seek FDA approval for those uses.”

This latest outcome will certainly encourage other pharma companies looking to promote their drugs off-label. They will be buoyed by the knowledge that it is unlikely the regulator will be able to oppose them, so long as this promotion is based on fact.

Is the FDA losing its grip on off-label promotion? The Amarin case, following other defeats, would suggest so. The Agency’s remit is, of course, to protect patients from harm where the benefit or safety of a drug is unproven, but it cannot prevent salespeople from telling doctors the said drug could be beneficial in an unapproved indication, if this claim can be backed up with trial data.

These sales reps must however ensure they stick to vetted scripts in their conversations with doctors, for if they are given free rein to converse unscripted on off-label drug uses, they are inviting misbranding action.

Trade groups like PhRMA will continue to press the FDA for guidance recognising the value of truthful information in drug promotion, and the industry will be watching closely for future developments and for any sign of opportunity.  

Joel Levy

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