Amarin wins injunction against FDA in free speech case

Amarin sued the FDA in May shortly after the agency refused to approve the drug for statin patients.

Success for Amarin “has the potential to establish precedent that would return the country to the pre-1962 era when companies were not required to prove that their drugs were safe and effective for each of their intended uses”, the FDA warned.

Amarin’s prescription-grade omega-3 fatty acid is approved to treat severely high triglycerides – a measure of fat in the blood.

The pharmaceutical industry has been watching this case because it is one of the first to raise a First Amendment argument in defense of promoting drugs for uses the FDA has not approved.

The question over where drug makers should be allowed to distribute information about unapproved uses of their medicines has been widely debated after a federal appeals court overturned the criminal conviction of a sales rep for promoting so-called off-label uses of a drug three years ago.

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

Off label marketing has a long and odd history in the United States.

“It’s a huge victory”, said Samp, whose law and policy center advocates against government interference in business. The court ruled his actions constituted protected speech because the information was truthful and not misleading. A spokeswoman for the agency declined to comment on the ruling Friday morning.

The company said it wanted to share with doctors the positive results of a 2011 study on the impact for the larger patient group and other information about “supportive but not conclusive” research that its drug could reduce coronary disease.

“This lawsuit is based on the principle that better informed physicians will make better treatment decisions for their patients”, the CEO of Amarin, John Thero, said in a statement.

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.

It’s a matter of great controversy surrounding the practice of “off-label” prescription.

According to Amarin, the court said that the company can promote to healthcare professionals certain uses of its main product, Vascepa, that are not now covered by the FDA-approved lableing for the drug. Vascepa should not be taken in place of a healthy diet and lifestyle or statin therapy. 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.