Amarin, FDA Seek One More Month to Hash Out Off-Label Promotion Settlement

Regulatory NewsRegulatory News | 18 February 2016 |  By 

Biopharma company Amarin and the US Food and Drug Administration (FDA) have jointly requested one more month to try to settle a landmark off-label promotion lawsuit.

This is the third call for an extension to the settlement talks and it comes six months after the US District Court for the Southern District of New York court ruled in August that Amarin can make certain truthful and non-misleading statements about off-label uses of its omega-3 drug Vascepa (icosapent ethyl). 

That declaratory judgment remains in effect while the settlement talks are ongoing, Amarin said. Both sides requested that further court proceedings be stayed until 18 March 2016.

Lawsuit Details

The judgment, which was a landmark victory for industry over FDA’s regulation of off-label promotion, allowed Amarin to disseminate promotional materials to doctors on an unapproved indication for Vascepa.

The lawsuit was linked to Amarin’s intention to send physicians three types of information relating to the use of Vascepa in patients with persistently high triglycerides, but which FDA had denied since it rejected that indication for the drug. 

Amarin stated in its complaint that it did not intend to promote this use of Vascepa in direct-to-consumer advertising, but only sought to “engage in truthful, nonmisleading speech about Vascepa directly with healthcare professionals.” 

Broader communication of truthful information about Vascepa will make physicians better informed with the current scientific data, Amarin contended.

But the company’s interest in promoting Vascepa for use in patients with high triglycerides came after an FDA advisory committee voted against and FDA later rejected the approval of the drug for that indication.

Amarin said that FDA concluded the Complete Response Letter “with a warning that any effort by Amarin to market Vascepa for the proposed supplemental use could constitute ‘misbrand[ing] under the Federal Food, Drug, and Cosmetic Act,’” which Amarin argued was in violation of its First Amendment rights.


In siding with Amarin, the US District Court acknowledged the lawful use of FDA-approved drugs for off-label uses and the inability of FDA to regulate those uses. 

The court also offered its own revised disclosure statement that Amarin must include in disseminating the off-label promotional material: “Vascepa is not FDA-approved for the treatment of statin-treated patients with mixed dyslipidemia and high (> 200 mg/dL and < 500 mg/dL) triglyceride levels due to current uncertainty regarding the benefit, if any, of drug-induced changes in lipid/lipoprotein parameters beyond statin lowered low-density lipoprotein cholesterol on cardiovascular risk among statin-treated patients with residually high triglycerides. No prospective study has been conducted to test and support what, if any, benefit exists.” 

As the FDA Law Blog notes, the ruling appears to bar FDA from prosecuting a pharmaceutical manufacturer for truthful and non-misleading off-label promotion, although “this precedent has only been established in the Second Circuit to date and there is considerable uncertainty as to how sister Circuits would rule if faced with the same set of facts.” 

And the ruling did seem to make a case for manufacturers to work with FDA on its off-label promotion speech so as not to falsely represent the benefits of a drug, noting:

“Although the FDA cannot require a manufacturer to choreograph its truthful promotional speech to conform to the agency’s specifications, there is practical wisdom to much of the FDA’s guidance, including that a manufacturer vet and script in advance its statements about a drug’s off-label use. A manufacturer that leaves its sales force at liberty to converse unscripted with doctors about off-label use of an approved drug invites a misbranding action if false or misleading (e.g., one-sided or incomplete) representations result.”

Amarin declined to comment on the settlement talks with FDA.


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