Federal Court Says Promoting Off-Label Drug Use Protected By Free Speech

Pharmaceutical companies may now be able to provide truthful and non-misleading information about the off-label use of drugs already approved by the U.S. Food and Drug Administration (FDA) after a recent U.S. district court ruling.

The landmark court case (bit.ly/1Lwp3Vk) involved a lawsuit filed by Amarin Corporation against the FDA for restricting the promotion of the off-label use of icosapent ethyl (Vascepa) in patients with cardiovascular disease and persistently high triglycerides after statin therapy. The FDA approved the drug in July 2012 only for use in patients with severe (≥ 500 mg/dL) hypertriglyceridemia.

Amarin wanted to offer icosapent ethyl to an expanded patient population and conducted the ANCHOR trial to demonstrate that the drug lowered triglycerides in patients with levels between 200 mg/dL and 500 mg/dL uncontrolled by diet and statin therapy. The company says the drug is medically accepted for this use and physicians commonly prescribe it to these patients. Amarin also launched a second trial (REDUCE-IT) to evaluate the drug’s efficacy in reducing cardiovascular mortality and morbidity in high-risk patients on statin therapy. Results of the trial should be ready for publication in 2018, according to the company.

Despite the findings of the ANCHOR trial and launch of the REDUCE-IT study, the FDA has repeatedly denied approving Vascepa for lowering triglyceride levels in patients on statins. The denials prompted Amarin to challenge the constitutionality of restricting information that the company believed would fully inform prescribing physicians about a proven option for improving the care of high-risk patients.

"This lawsuit was based on the principle that better informed physicians will make better treatment decisions for their patients," John Thero, president and chief executive officer of Amarin, said in a statement. "Many physicians are aware of the efficacy data included in FDA-approved labeling for Vascepa, but are not aware of efficacy data from the ANCHOR study of Vascepa.”

Mr. Thero said Amarin is now free to communicate efficacy data from ANCHOR and relevant studies to physicians and healthcare professionals in the context of appropriate disclaimers.

The impact of the court’s decision will be felt beyond the walls of Amarin’s headquarters. “It’s a significant victory — both for the industry and for the First Amendment,” said Joel Kurtzberg, a partner at the Cahill, Gordon and Reindel law firm in New York City and the lawyer who represented Amarin. “The decision made clear — clearer than any other decision has before it — that the FDA cannot prohibit the truthful and non-misleading promotion of off-label uses for FDA-approved drugs.”

Mr. Kurtzberg said the FDA has in the past sought to regulate dangerous off-label uses by regulating drug manufacturers’ legitimate claims of off-label uses. “That is precisely what the First Amendment does not allow,” he commented.

—Dan Cook

References:

1. Amarin Corp. First Amendment Decision a Win for Amarin and Physician Plaintiffs [press release]. www.amarincorp.com. 2015 Aug 7.

2. Amarin Pharma, Inc. et al v. United States Food & Drug Administration et al, No. 1:2015cv03588 - Document 73 (S.D.N.Y. 2015). law.justia.com. Accessed August 25, 2015.

3. Shacat J. Court Ruling Allows Amarin to Promote Vascepa Off-Label. FDANews. www.fdanews.com. 2015 Aug 14.