Fish Oil Maker Sues FDA

AMARINAmarin Pharmaceuticals, which was rebuffed by the Food and Drug Administration in its effort to market its fish oil pill Vascepa to treat high triglycerides, is suing the agency, saying its First Amendment rights are being violated.

To make its case, the small drugmaker has hired one of the nation?s top free speech lawyers, Floyd Abrams of the New York law firm Cahill Gordon & Reindel, to make its case. Abrams and his colleagues are also representing several doctors who say they want to be able to get information about using Vascepa to lower triglycerides, which may raise the risk of heart attacks and strokes. Right now, Vascepa is only approved for lowering extremely high triglyceride levels, above 500 milligrams per deciliter, while other drugs can be used about 200 mg/dL.

?It?s a First Amendment case,? says Abrams, who is also representing tobacco companies in a case that challenges the FDA?s ability to require graphic labeling. ??It?s a case which challenges the ability and the power of the FDA to limit speech and potentially punish it notwithstanding that the speech is both important in nature and has every aim of serving the public. ?

A great deal of the FDA?s marketing power comes from its ability to regulate speech. Drugs are approved for particular uses, and their manufacturers are allowed to market them to doctors and consumers only for the particular uses that have been vetted by the FDA. Doctors are allowed to prescribe medicines for anything they want, but if drug companies are caught encouraging those prescriptions, it is considered illegal. The bulk of the more than $13 billion in fines pharmaceutical firms have paid in recent years have been related to this so-called off-label marketing.

But Amarin?s lawyers insist that their case is drawn up specifically enough that it would not undermine the FDA?s power. Joel Kurtzberg, another lawyer at Cahill, says that a court could rule in Amarin?s favor but that other drug companies seeking to market outside their labels would still find themselves having to either go to court ahead of time or to make the marketing claims at the risk of regulatory action. ?I don?t think it opens the can of worms that you talked about,? says Kurtzberg.

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