Pharmaceutical firm Amarin Corp. Plc has reached a legal settlement to promote its fish oil pill for unapproved uses. The U.S. Food and Drug Administration decides not to appeal the ruling that the company has the First Amendment right to make truthful, non-misleading claims about its products.
Back in August, U.S. District Judge Paul Engelmayer – through a preliminary injunction – allowed Amarin off-label promotion for Vascepa, a drug used to lower fat levels.
“[T]he court held the FDA’s restrictions on such speech were more extensive than necessary, and thus breached the First Amendment,” read part of the ruling.
Now under a settlement between Amarin and the FDA, the regulatory agency agrees to adhere to the earlier court decision, said Amarin last Tuesday.
In its statement, the FDA clarified that the settlement pertains specifically to this situation and does not herald a new legal precedent. It reiterates its role of protecting Americans through ensuring that “medical products meet the rigorous legal standards for safety and effectiveness for their intended uses.”
Drug companies are legally barred from making marketing drugs for off-label uses, yet the limits of “commercial speech” remain at the center of their ability to distribute marketing materials and information about their products.
In 2012, the FDA approved Vascepa for use among patients with extremely high triglyceride levels. It rejected a second use that would have allowed Amarin to market the same drug for patients with lower triglycerides who also take statins, a class of cholesterol-lowering medications. The agency sought more data on the effectiveness of lowering triglycerides in reducing heart problems in those patients.
In May last year, Amarin hit back with a lawsuit, arguing that FDA’s effort to stop it from sharing off-label information violates its free speech protections. The federal court ruling in August sided with Amarin.
Experts and public health advocates feared that this settlement would prompt companies to pursue legal action against the FDA, and pave the way for the drug firms to sell their products for conditions which they have not been tested for.
The American Medical Association showed that in the last decade alone, pharmaceutical companies have shelled out over $16 billion in settlements for off-label promotion.
Attorney Lisa Dwyer, though, believed that the settlement had its limitations and would apply to Amarin alone. It has not reached a point where one should extrapolate to other companies, she said.
According to a 2012 study, up to three-quarters of results from published pre-clinical trials could not be reproduced, while a separate study showed that 41 percent of the time, scientists were unable to corroborate 34 claims from typically cited published trials.
Read here the proposed settlement order (PDF), which is subject to court approval.
Photo: Brian Turner | Flickr
