Amarin's action has initiated a debate on whether the FDA's authority over ensuring the safety and efficacy is being side-stepped.
Drugmakers have long argued they should have the right to talk to doctors about unapproved uses for their products, as long as they are being truthful. And in some cases, courts have agreed. But the federal government still frowns on the practice and, in recent years, has fined drug companies billions of dollars for talking to doctors about so-called off-label uses for their medications.
On Thursday, Amarin Pharma took the unusual step of suing the FDA, arguing that it has a constitutional right to share certain information about its product with doctors, even though the agency did not permit the company to do so. Lawyers for the company said that they believed their case was the first time a manufacturer had pre-emptively sued the agency over the free-speech issue, before it had been accused of any wrongdoing. Other companies have sued the agency only after they have gotten into trouble.
Complete article on The New York Times: http://nyti.ms/1zJIZiC