The FDA Just Lost a Lawsuit That Could Change How Drugs Are Regulated

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A small drug company has won an early fight in its case against the FDA, which will allow it to promote its fish-oil pill for treatments not explicitly approved by the agency. The federal case has huge implications for the future of prescription drugs in the US and could weaken the FDA’s power to regulate how drugs are marketed.

As the Wall Street Journal reports, Irish pharmaceutical company Amarin promotes its drug Vascepa as a way to reduce heart disease in some people who are taking statins. But the company sought to broaden its consumer base. Unfortunately for Amarin, drug companies are forbidden from promoting unapproved uses of any drug, commonly called “off label” marketing, to doctors and the public.

The FDA had approved Vascepa for use in people with very high levels of triglycerides, but it hasn’t been approved in people with low levels of triglycerides. This, despite the fact that Amarin claimed it had clinical drug trials to support its efficacy.


The company filed its lawsuit on First Amendment grounds in May. District court judge Paul Engelmayer ruled in Amarin’s favor today.

With the court order, the company can now effectively promote its pill for whatever it likes, as long as those promotions are deemed truthful and “not misleading” — whether or not the FDA has approved of that particular use.

“This lawsuit is based on the principle that better informed physicians will make better treatment decisions for their patients,” the CEO of Amarin, John Thero, said in a statement.

Off label marketing has a long and strange history in the United States. Historically the FDA has aggressively gone after companies that market their drugs for uses that haven’t been explicitly approved. Just last year GlaxoSmithKline was ordered to pay a $105 million fine for off label promotion of its asthma and anti-depressant medications. Today’s ruling has the potential to hinder such prosecutions against drug companies in the future.


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