Respecting the First Amendment rights of businesses to make truthful claims, a federal court judge in New York said the Food and Drug Administration could not limit Amarin Pharma, Inc.'s statements about off-label uses of its drug Vascepa because the claims were not misleading.

In granting the pharmaceutical manufacturer's motion for a preliminary injunction against the agency, U.S. District Court Judge Paul A. Engelmayer said the company could make statements about the omega-3 drug's benefits for patients with "persistently high triglycerides" (with levels between 200 and 499 mg/dL) even though it does not have FDA approval to treat such a population. Currently Amarin only has clearance to market Vascepa to adult patients with "very high triglycerides," with levels above 500 mg/dL.

The dispute arose from a criminal action against Alfred Caronia, a pharmaceutical sales rep for Amarin Pharma. The FDA charged Caronia with violating the Food, Drug and Cosmetic Act after he promoted Vascepa for off-label use. Caronia appealed his conviction for conspiring to introduce a misbranded drug into interstate commerce to the Second Circuit Court of Appeals, which the three-judge panel reversed in 2012.

According to the court in U.S. v. Caronia, the misbranding provisions of the FDCA must be construed "as not prohibiting and criminalizing the truthful off-label promotion of FDA-approved prescription drugs" where the off-label use itself is lawful.

Amarin then sought to make statements to doctors about the off-label use of Vascepa based on two clinical trials. But the FDA rejected the proposals and threatened to take legal action. Amarin filed suit seeking an injunction to halt the agency from bringing misbranding charges against the company and its employees.

Relying heavily upon Caronia, Judge Engelmayer granted the relief.

The court rejected the FDA's narrow reading of Caronia as a "fact-bound decision" that turned on the jury instructions in his trial. "The Court's considered and firm view is that, under Caronia, the FDA may not bring such an action based on truthful promotional speech alone, consistent with the First Amendment," the court wrote, quoting the Second Circuit opinion: "To the extent there is any ambiguity as to whether off-label promotion is tantamount to illegal misbranding, we construe the FDCA narrowly to avoid a seriously constitutional question."

"Speech in the aid of pharmaceutical marketing is a form of expression protected by the First Amendment, the court said. Because off-label use of approved drugs is lawful, prohibiting the truthful promotion of off-label drug usage by a particular class of speakers would not enhance the FDA's approval process or reduce patient exposure to unsafe or ineffective drugs. Instead, allowing such actions paternalistically interferes with the ability of physicians and patients to receive potentially relevant information, the court explained."

"Therefore, insofar as Amarin seeks preliminary relief recognizing its First Amendment right to be free from a misbranding action based on truthful speech promoting the off-label use of an FDA-approved drug, Amarin has established a substantial likelihood of success on the merits on this point," Judge Engelmayer wrote.

To read the opinion and order in Amarin Pharma, Inc. v. FDA, click here.

Why it Matters: In a resounding victory for Amarin (and the pharmaceutical industry in general), the court rejected the FDA's concerns that the holding could undermine the drug approval process. Judge Engelmayer emphasized that the First Amendment does not protect false or misleading commercial speech and that "the dynamic nature of science and medicine is that knowledge is ever-advancing." He placed the burden on Amarin going forward to ensure that its communications—while fair and balanced today—remain truthful and non-misleading as new studies are done and new data is acquired.