Prescription Fish Oil Maker Hires Top Lawyer To Sue FDA On First Amendment Grounds
Amarin 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, because doing so may lower 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.
The legal filing, which is being made in the Southern District of New York, builds upon a previous case, U.S. v. Caronia, which involved Xyrem, a narcolepsy drug made by Jazz Pharmaceutical, and ruled “the government cannot prosecute pharmaceutical manufacturers and their representatives under the FDCA for speech promoting the lawful, off-label use of an FDA-approved drug.”
The filing also makes several points in Amarin’s favor: that fish-oil-containing dietary supplements can make a claim that “supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease;” also that other drugs to lower triglycerides, like niacin and TriCor, both sold by AbbVie, and the fish oil pill Lovaza, made by GlaxoSmithKline, are allowed to be marketed to a broader swath of people with high triglycerides.
But the claim softpedals the scientific debate of whether any of the medicines do any good. Recent randomized controlled trials of fish oil, including one published in the Journal of the American Medical Association and another in the New England Journal of Medicine, have shown little benefit from taking it to prevent heart attacks. Vascepa is higher dose and more pure, and a similar fish oil product seemed to show a benefit in a clinical trial in Japan, but the data remain murky, many cardiologists say.
“We have no idea whether these triglyceride drugs work and that needs to inform all of our decisions about whether they’re available, how they’re promoted, and who should use them,” says Harlan Krumholz, the Harold H. Hines, Jr. Professor of Medicine at Yale University.
Sales of Vascepa were just $54 million last year. Amarin is conducting a big study of whether Vascepa prevents heart attacks and strokes, but it will not be completed until 2017.