The court recently extended its stay of the proceedings in Amarin Pharma Inc.’s suit against the FDA challenging threatened agency action concerning the alleged promotion of drugs for off-label uses See Amarin Pharma, Inc. v. FDA, No. 15-cv-3588 (S.D.N.Y., order 10/30/15). The stay to December 17th is reportedly to give the parties more time to engage in settlement discussions. This one remains a case to watch for those in the pharma practice area.
First Amendment doctrine, and its relationship to the FDCA, has changed dramatically since the FDCA and many of its implementing regulations were adopted. And one may question whether the FDA has kept up with these changes.
Earlier this Summer, the district court granted a motion for preliminary injunction in favor of Amarin, reaching the merits of Amarin’s First Amendment claims. The case concerned Vascepa , an omega-3 fatty acid obtained from fish oil. Vascepa was approved to reduce triglyceride levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia. Amarin was seeking a new indication pursuant to a Special Protocol Assessment (“SPA”) agreement with FDA, for patients with “persistently high” triglycerides (≥ 200 and ≤ 500 mg/dL). While Amarin believed it had satisfied all of FDA’s requirements to obtain the new approval, FDA disagreed and rescinded the SPA. FDA went further to warn Amarin that any effort by Amarin to market Vascepa for the proposed supplemental use could constitute “misbranding” under the Federal Food, Drug, and Cosmetic Act.
Amarin filed a civil complaint against FDA, claiming that this threat of prosecution for misbranding had a chilling effect on its commercial speech. Amarin proposed to engage in truthful, non-misleading speech about Vascepa directly with healthcare professionals, such as disseminating study results and reprints of peer-reviewed scientific publications. The company also proposed to make “contemporaneous disclosures” to ensure that the messages were not at all misleading.
The court noted that in contrast to FDA’s long-standing position that off-label promotion of drug products can constitute criminal misbranding, off-label use is not illegal and may even be the standard of care in some circumstances. The company relied on the Second Circuit’s First Amendment decision in Caronia, but the FDA argued Caronia was a narrow, fact-bound decision, turning on particular jury instructions given at the sales rep’s trial. At the least, it ought to be construed in harmony with FDA regulations distingusihing between directed off-label speech and requests by the practicioner for information. The court rejected FDA’s interpretation, finding the FDA may not bring such an action based on truthful promotional speech alone. “Where the speech at issue consists of truthful and non-misleading speech promoting the off-label use of an FDA-approved drug, such speech, under Caronia, cannot be the act upon which an action for misbranding is based.”
With this rule in mind, the court evaluated and ruled on each of Amarin’s proposed off-label statements concerning Vascepa along with FDA’s responses. This included the “agreed-upon statements and disclosures,” which were found to be “based on current information, truthful and non-misleading.” And then the additional “contested disclosures” (such as “not-approved for” use language). The court eventually crafted a revised hybrid disclosure on that. The court also said the proposed cardiovascular disease claim, as revised during litigation, given its qualified phrasing and its acceptance in other contexts by the FDA, was presently truthful and non-misleading.
The court offered a few important caveats: 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.
And the dynamic nature of science and medicine is such that knowledge is ever-advancing. A statement that is fair and balanced today may become incomplete in the future as new studies are done or new data is acquired.
Again, one to keep an eye on.