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. . . A federal judge ruled that the Food and Drug Administration (FDA) cannot prohibit a pharmaceutical company from marketing its drugs for off-label uses if its claims are truthful and not misleading. This ruling, while not precedential, alters the traditional compliance analysis regarding the legality of off-label marketing.
This decision, Amarin Pharma Inc. et al v United States Food & Drug Administration et al, 1:15-cv-03588-PAE (NYSD) [enhanced opinion available to lexis.com subscribers | Lexis Advance], follows precedent established in 2012 in United States v. Caronia [enhanced opinion available to lexis.com subscribers | Lexis Advance], in which the Second Circuit vacated the conviction of a pharmaceutical sales representative who engaged in the off-label promotion of a drug, holding that the First Amendment does not permit one’s conviction solely on the basis of truthfully promoting off-label uses. However, in the Amarin decision, Judge Engelmayer expanded the scope of Caronia by concluding that truthful and non-misleading speech cannot serve as the basis for a misbranding action.
In 2012, the FDA approved Amarin’s drug, Vascepa®, for patients with very high triglyceride levels, a condition known to increase the risk of pancreatitis and cardiovascular disease. However, the FDA rejected a second use of the drug that would have allowed Amarin to market Vascepa to patients with persistently high triglycerides who also take statins (i.e., drugs used to lower cholesterol). Although it was undisputed that Vascepa was safe and effective in reducing such triglyceride levels, the FDA told Amarin it needed to submit additional data regarding whether lowering triglyceride levels for patients on statins actually translates to a reduced cardiovascular risk. Absent formal approval, the FDA contended that distributing information about the alternate use would constitute misbranding under the Federal Food, Drug, and Cosmetic Act (FDCA).
Amarin subsequently filed a lawsuit seeking declaratory and injunctive relief that would prevent the FDA from prosecuting it for truthful, non-misleading speech concerning Vascepa. Amarin argued that the FDA’s efforts to stop it from sharing “off-label” information would violate its free speech protections. In a 71-page opinion, Judge Engelmayer agreed with Amarin and ruled that, consistent with the First Amendment, Amarin “may engage in truthful and non-misleading speech promoting the off-label use of Vascepa.” Notably, the judge opined: “In the end . . ., if the speech at issue is found truthful and non-misleading, under Caronia, it may not serve as the basis for a misbranding action.”
The FDA has 60 days to appeal Judge Engelmayer’s ruling. If the decision stands, it could continue to pave the way for pharmaceutical companies and medical device manufacturers to engage in the off-label marketing of drugs that is truthful and not misleading. While Amarin and Caronia signal a potential change in the way the government will have to approach off-label marketing cases, it is important to note that these decisions both come out of the Second Circuit, and it still is uncertain how other circuits will rule when presented with similar facts.
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