Unfortunately for Amarin, drug companies are forbidden from promoting unapproved uses of any drug, commonly called “off label” marketing, to doctors and the public.
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The legal battle ensued after Amarin requested that the court stop the FDA from enforcing its off-label marketing ban with an injunction and the court obliged, the Wall Street Journal reports.
The preliminary ruling in U.S. District Court could strengthen the pharmaceutical industry’s ability to distribute information about drug uses that have not been cleared by the FDA.
Amarin sued the FDA in May shortly after the agency refused to approve the drug for statin patients.
The order by U.S. District Judge Paul Engelmayer in Manhattan means Amarin can promote its Vascepa pill to doctors for off-label use as long as it does so truthfully. The only requirements the judge put in place were that the promotion effort by Amarin is truthful and non-misleading.
Off-label use of drugs is permitted and often happens, but the FDA gets really concerned when education becomes pure marketing and risks get downplayed in the process.
The FDA has not approved this use, but doctors are allowed to prescribe drugs for any condition.
The FDA has approved Vascepa to treat patients with very high levels of blood fats known as triglycerides that have been linked to diabetes, kidney failure and pancreatic cancer.
Sarah Peddicord, an FDA spokeswoman, declined to comment on the ruling, which remains in effect until another trial can be heard.
In 2012 the US Court of Appeals Second Circuit vacated the conviction of Caronia, a former sales rep for Jazz Pharmaceuticals.
Still, the Dublin based Amarin Corporation PLC, has said that so severely regulating what information is conveyed along with their product effectively denies the company the right to free speech. It argued its First Amendment rights would be trammeled by the federal agency if it were not able to discuss such findings.
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CEO John Thero said that the lawsuit is based on a fact that if doctors will be better informed about the drug then they will be in a better position to take decision for their patients. Shares of Amarin rose 12 percent on Nasdaq. Amarin’s lead product, Vascepa (icosapent ethyl) capsules, are used as an adjunct to diet to reduce triglyceride levels in adult patients with severe (triglyceride or TG over 500 milligrams per deciliter) hypertriglyceridemia. The FDA had previously agreed that a cardiovascular study wouldn’t be needed before approval, though that was before studies on other drugs failed to show a heart benefit from lowering triglycerides.
