Court sides against FDA in “off-label” drug promotion case

In 2013, the FDA cancelled a special protocol assessment (SPA) for the ANCHOR trial with regard to Amarin’s request to expand the drug’s use among adults having high triglycerides with mixed dyslipidaemia.

Amarin said it can now use information from research that showed Vascepa reduced the risk of coronary heart disease.

However, Amarin, the company behind the fish-oil drug called Vascepa, said that the restrictions posed by the FDA are abusive and go against the First Amendment.

“Healthcare professionals routinely lawfully prescribe FDA-approved drugs for unapproved uses, and informed patient care relies upon doctors having access to accurate, comprehensive, and current information about such uses”, Mit Spears, PhRMA’s general counsel, said in a statement.

Following a series of discussions, the company decided to initiate a rare Constitutional challenge, arguing the FDA’s muzzling of its efforts to communicate truthful information to doctors breached the company’s First Amendment right to free speech.

Amarin also wants to market the pill to doctors for patients who have more moderately elevated levels of triglycerides despite already taking statins, another type of drug that lowers blood fats.

Sarah Peddicord, an FDA spokeswoman, declined to comment on the ruling, which remains in effect until another trial can be heard. But companies’ ability to distribute independent materials about their drugs – such as medical journal articles – has been subject to years of legal debate. And FDA regulators suggested that distributing information about the alternate use would be illegal. Judge Paul Engelmayer agreed in a 71-page opinion.

After a new ruling by a court of the U.S., the FDA loses the case against drug marketing.

Amarin has said that it plans to promote Vascepa for statin patients by telling doctors about recent clinical findings supporting the off-label use.

Some lawyers said Friday that other companies could follow a similar path by filing lawsuits in the second circuit.

Other experts were less convinced of the cases’ importance.

All could have been resolved in a matter of weeks, according to Loss, with no hassle, but if the company insists to “strut and think they accomplished a great achievement by beating the FDA in court, they’re free to do it.”.

Amarin Corporation PLC is based in Dublin, Ireland.

Amarin’s American depositary receipts rose 16 percent to $2.37 at 11:54 a.m.in New York, after climbing as much as 27 percent in the biggest intraday gain since May 28. Fish oil is thought to lower heart disease risk, though no definitive studies have yet established that benefit.