Irish drugmaker sues FDA under First Amendment

By Toni Clarke

(Reuters) - Amarin Corp Plc (AMRN.O), an Irish drugmaker trying to expand the market for its fish-oil pill, has sued the U.S. Food and Drug Administration for restricting its right to promote the drug for unapproved, or off-label, use.

The lawsuit, filed on Thursday in federal court in New York, argues that the FDA's ban on drug company promotions of their products for unapproved uses violates Amarin's right to free speech under the First Amendment. Amarin is represented by eminent U.S. constitutional lawyer Floyd Abrams.

It is the first lawsuit of its kind against the FDA since 2012, when a U.S. court overturned the conviction of a drugs salesman, Alfred Caronia, caught talking to physicians about off-label uses of the narcolepsy drug Xyrem. It ruled that the First Amendment protected truthful and non-misleading off-label speech.

"Over the last 10 years the Supreme Court ... has provided more protection for commercial speech than had been the case before and has been more willing to conclude that commercial speech was protected, even though there were substantial arguments to the contrary," said Abrams, a partner at Cahill Gordon & Reindel LLP.

Amarin sells Vascepa, a fish-oil pill approved by the FDA to treat patients with exceptionally high levels of blood fats known as triglycerides that have been linked to diabetes, kidney failure and pancreatic cancer.

Amarin also wants to market the drug for patients with high, but not exceptionally high, triglyceride levels. It applied to the FDA for permission to do so based on the results of a trial that showed Vascepa lowered triglycerides in this group.

Amarin's hypothesis, shared by some physicians, is that lowering triglycerides reduces the risk of heart attack. The company is conducting a trial to evaluate whether that is the case. The results are expected in 2018.

The company had wanted in the meantime to market the pill simply as a triglyceride-lowering agent, but an FDA advisory panel recommended it not be approved for the broader population until the results of the trial were in. Last month the agency rejected the company's application, prompting the lawsuit.

The FDA said previously it had crafted the restrictions on off-label promotion to protect public health after drug companies were repeatedly found pushing products for uses for which there was no scientific evidence to show they were safe and effective.

Amarin insists the information it wants to provide is both factual and not misleading. And it argues that while some doctors may not want the information, those that do should be allowed to get it.

An FDA spokeswoman, Andrea Fischer, said the agency "does not comment on pending litigation."

(This version of the story corrects the name of court in paragraph 2 from federal appeals court to federal court)

(Editing by Ted Botha)