Pharma, Policy

FDA’s new Amarin decision could change the way drugs are marketed off-label

The Food and Drug Administration just OKed biopharma company Amarin to promote its only drug, Vascepa, for off-label use.

VascepaInvoking the First Amendment has turned out to be a powerful tool for pharmaceutical marketers: After a lengthy battle, the Food and Drug Administration just OKed biopharma company Amarin to promote its only drug, Vascepa, for off-label use.

This is a big deal. While regulators have long given physicians express permission to prescribe drugs for off-label medical use, drugmakers have only been allowed to market their wares for indications that are approved by the FDA.

With Tuesday’s announcement, however, this could open up the floodgates for biopharmaceutical companies to promote therapeutics for a wider range of diseases – ultimately broadening their potential consumer pool.

This follows an injunction last August from a federal judge in New York that said the FDA couldn’t restrict Amarin from using accurate data to market its drug for off-label indications. The judge invoked the First Amendment, saying that restricting the advertising would interfere with the company’s right to free speech. Reuters writes:

The closely watched case is the first to defend the promotion of drugs on First Amendment grounds since 2012. Then, a U.S. court overturned the conviction of drugs salesman Alfred Caronia, who was caught talking to physicians about unapproved uses for the narcolepsy drug Xyrem. The court ruled that the First Amendment protected truthful and non-misleading speech.

However, as the New York Times points out, the FDA is reticent to say that this ruling could have wide implications in biopharmaceutical marketing:

The agency on Tuesday downplayed the implications of the deal. In a statement, it said that the settlement applied only to the Amarin case and that its position on whether companies have a constitutional right to provide truthful information about off-label uses had not changed.

But some legal and drug-safety experts said the settlement could encourage other companies to seek similar arrangements and, ultimately, have profound implications for how drug makers sell their products.

“This really sends a signal to other companies that if you want to engage in off-label promotion, you can negotiate with the F.D.A.,” said Dr. Michael Carome, director of health research at Public Citizen, a consumer advocacy group in Washington.

“Ultimately, that’s taking us down a dangerous pathway.”

Vascepa, in essence, is an omega-3 fatty acid derivative of fish oil that’s available for prescription. The drug is approved for use in treating high cholesterol, but omega-3s have been studied in a wide range of indications – and Amarin is looking to expand its marketing claims to follow suit.