So what: A U.S. District Court has ruled that Amarin is now allowed to promote Vascepa, the company’s lead product that is used to control triglyceride levels, beyond the currently approved FDA labeling as long as the promotion is truthful and does not mislead providers.
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“Although recognizing that the FDA’s policies advanced a substantial government interest in requiring manufacturers to submit supplemental applications for new drug uses”, the district judge wrote in his opinion, “the court held the FDA’s restrictions on such speech were more extensive than necessary, and thus breached the First Amendment”.
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.
Amarin wanted to provide doctors with clinical trial data that didn’t directly pertain to the approved uses of its Vascepa prescription fish-oil pill.
In 2013, the FDA cancelled a special protocol assessment (SPA) for the ANCHOR trial with regard to Amarin’s request to expand the drug’s use among adults having high triglycerides with mixed dyslipidaemia. A spokeswoman for the agency declined to comment on the ruling. Amarin is also developing Vascepa for the treatment of patients with high (TG over 200 milligrams per deciliter and less than 500 milligrams per deciliter) triglyceride levels who are also on statin therapy for elevated low-density lipoprotein cholesterol (LDL-C) levels. While doctors are already allowed to prescribe drugs off-label, drugmakers have been restricted on promoting such uses. And FDA regulators suggested that distributing information about the alternate use would be illegal. The only requirements the judge put in place were that the promotion effort by Amarin is truthful and non-misleading.
The decision means the FDA needs to more broadly apply a 2012 ruling overturning a criminal conviction of a sales representative for promoting an off-label drug, said Richard Samp, chief counsel at the Washington Legal Foundation. Analyst Ira Loss noted that the FDA neutralized many of Amarin’s points in a court filing released in June.
CEO John Thero said that the lawsuit is based on a fact that if doctors will be better informed about the drug then they will be in a better position to take decision for their patients.
“The FDA said they could do all those things weeks ago”, said Loss.
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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. 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.
