May 8, 2015
By Alex Keown, BioSpace.com Breaking News Staff
BEDMINSTER, N.J. – Amarin Corporation , the maker of Vascepa, a federally approved prescription Omega 3 fatty acid, as filed a lawsuit against the U.S. Food and Drug Administration (FDA) for restricting the company’s right to sell the fish oil drug for off-label use, Reuters reported this morning.
In its lawsuit, which was filed Thursday in U.S. District Court for the Southern District of New York, Amarin said the FDA’s ban violated the company’s First Amendment-protected right to free speech under the U.S. Constitution. Amarin said it wants to share “truthful and non-misleading information” with physicians about Vascepa.
According to the lawsuit, Amarin “seeks a judicial declaration that FDA regulations limiting off-label promotion of such truthful and non-misleading information are unconstitutional under the First Amendment.” In its lawsuit, the company said it wants to communicate directly with healthcare workers (not the general public) about the efficacy data of Vascepa trials in patients with high triglyceride levels despite statin therapy as well as a health claim the company said the FDA has supported for more than 10 years 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.”
“The plaintiffs contend that broader communication of truthful information about Vascepa will improve patient care by making physicians better informed with current scientific data before deciding how to treat patients consistent with multiple national and international medical treatment guidelines. Currently, FDA regulations restricting off-label promotion limit this type of truthful and non-misleading communication, preventing most physicians from making fully-informed treatment decisions,” the company said in its filing.
Four physicians are involved in the lawsuit who said they want to get additional information about Vascepa to prevent heart attacks and strokes through lowering of triglycerides. Amarin is currently prohibited from sharing additional information.
Amarin and the individual physician plaintiffs are represented in the lawsuit by Floyd Abrams, Joel Kurtzberg and Michael Weiss, partners at Cahill Gordon & Reindel.
The FDA maintains authority over speech in the way approved medications are marketed. In an article about the lawsuit Forbes noted that “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, on the other hand, can prescribe medications to their patients even if it doesn’t match the approved FDA marketing data.
However, drugmakers are prohibited from encouraging doctors to prescribe medications for anything other than what the FDA has approved.
Currently Vascepa is only approved for lowering high triglyceride levels, above 500 milligrams per deciliter. In its complaint the company noted that approximately 20 percent of all prescriptions in the United States are used by physicians for such “off-label” indications.
The court has ruled that the First Amendment protected truthful and non-misleading off-label speech in U.S. v. Caronia, which involved Xyrem, a narcolepsy drug made by Jazz Pharmaceuticals . Forbes noted 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.”
Amarin has been seeking a wider use approval for Vascepa for a few years. Vascepa was approved in 2012, but in 2013 the company sought approval to market Vascepa to patients with blood fat abnormalities who are at high risk of coronary heart disease and are taking statins, such as Pfizer Inc. ‘s Lipitor.
Sales of Vascepa were just $54 million in 2014. Amarin is currently conducting a clinical study of whether Vascepa will prevent heart attacks and strokes, but the trial will not be completed until sometime in 2017.
Amarin stock was trading down this morning at a low of $1.87 per share, down from Thursday’s close of $1.99 per share.
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