Another Successful First Amendment Challenge to the Prohibition of Off-Label Promotion for FDA-Approved Drugs: Part Two

by Jackson Walker
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The Free Speech Clause notched another victory in the latest and, perhaps, final chapter of the lawsuit between the FDA and Amarin Pharma, Inc. concerning off-label marketing of an FDA-approved drug. On March 8, 2016, the FDA took the unprecedented step of settling the Amarin lawsuit,1 in which a federal district court previously granted a preliminary injunction that allowed Amarin to publish certain "truthful and non-misleading speech" promoting the off-label use of Amarin's drug Vascepa. The FDA agreed to terms that not only gave considerable concessions to the relatively small pharmaceutical manufacturer, but the settlement may also pave the way for other pharmaceutical companies to negotiate off-label marketing issues with the FDA.

A. The 2015 Amarin Decision

As discussed in our previous e-Alert, in August 2015, the U.S. District Court for the Southern District of New York granted a preliminary injunction in favor of Amarin that allowed it to publish information about off-label use of the drug Vascepa without fear of being prosecuted for misbranding. The Court held that "[w]here the speech at issue consists of truthful and non-misleading speech promoting the off-label use of an FDA-approved drug, such speech … cannot be the act upon which an action for misbranding is based." Amarin Pharma, Inc., 119 F. Supp. 3d at 226. That decision was a significant victory for pharmaceutical companies in the conflict between the First Amendment and the Federal Food, Drug, and Cosmetic Act ("FDCA"), which generally prohibits promoting products for any uses other than those specifically approved by the FDA.

Vascepa was initially FDA-approved to treat patients with high levels of triglycerides. Amarin then sought approval to publish information regarding off-label use for patients with somewhat lower levels of triglycerides. Notably, physicians regularly prescribed Vascepa precisely to this wider group of patients. Furthermore, FDA-approved studies had demonstrated the safety and efficacy of this off-label use. The FDA nevertheless rejected Amarin's request, warning that Vascepa "may be considered to be misbranded" under the FDCA if marketed for this particular off-label use.

After receiving the FDA's misbranding warning, Amarin preemptively filed suit against the FDA. Amarin argued that the FDA violated the company's First Amendment rights by prohibiting it "from making completely truthful and non-misleading statements about its product to sophisticated healthcare professionals." Amarin, 119 F. Supp. 3d at 212 (internal quotation marks omitted). The FDA asserted that the agency could use speech as evidence of the intent (mens rea) and the act (actus rea) of misbranding. Id. at 223. The FDA also argued that granting First Amendment protection to off-label promotion allows a manufacturer to sidestep the FDA drug approval process—which is intended to ensure that pharmaceutical companies market medications for uses that are proven to be safe and effective. Id. at 205.

The Court ultimately rejected the FDA's arguments, including the claim that off-label promotion might eviscerate the FDA drug-approval process. According to the Court, the FDCA's ban on off-label advertising was not narrowly tailored to further the asserted government interest and, therefore, failed to satisfy requirements established by U.S. Supreme Court's commercial speech analysis in Central Hudson Gas & Elec. Corp. v. Public Service Comm'n of New York, 447 U.S. 557, 562-63 (1980). Accordingly, the Court granted Amarin’s requested injunction and, thereby, protected Amarin’s efforts to engage in truthful and non-misleading speech about the off-label use of Vascepa. Amarin at 237.

B. The Unprecedented Amarin Settlement

Following the Court's thoughtful order granting Amarin’s preliminary injunction, the parties engaged in settlement discussions and reached an agreement six months later. In the settlement agreement,2 the FDA agreed to be bound by the Court's decision that Amarin may engage in "truthful and non-misleading" speech about the off-label use of Vascepa without facing misbranding charges. The settlement agreement specifically states, in part:

  1. [The FDA agrees] to be bound by the Court's conclusion that Amarin may engage in truthful and non-misleading speech promoting the off-label use of Vascepa®, i.e., to treat patients with persistently high triglycerides, and under Caronia,3 such speech may not form the basis of a prosecution for misbranding.
  2. [The FDA agrees] to be bound by the Court's conclusion that, based on the information known as of August 7, 2015, the combination of statements and disclosures that Amarin proposes to make to doctors relating to use of Vascepa® to treat persons with persistently high triglycerides, as such communications have been modified in the August 7 Order, is truthful and non-misleading.
  3. Amarin bears the responsibility, going forward, of assuring that its communications to doctors regarding off-label use of Vascepa® remain truthful and non-misleading.
  4. All terms contained herein are to be interpreted consistently with the August 7 Order, and nothing in this Order shall be construed to limit Amarin's constitutional rights to free speech concerning Vascepa®.

In an apparent attempt to avoid future disputes over what other off-label promotions are "truthful and non-misleading," the settlement agreement also formulated a procedure by which Amarin could submit a number of proposed off-label-use communications to the FDA for comment. This procedure established certain timeframes for each of the parties to object and respond to objections on proposed promotions. Although the FDA already has a general, optional procedure for agency "preclearance," the review process established in the settlement agreement is more regimented, particularly with regard to the inclusion of strict deadlines. The settlement agreement's review procedure also includes a dispute resolution process to resolve subsequent disagreements over whether communications are truthful and non-misleading.

C. Impact and Takeaways from Amarin

The Amarin saga is undeniably significant. The FDA has revealed a willingness to negotiate and even relax the standards that might have previously led to misbranding actions. But this case's impact should not be interpreted too broadly.  Neither the Amarin court decision nor the Amarin settlement gives drug manufacturers carte blanche to publish any and all off-label information about their products. The decision and settlement were primarily a product of the unique facts and circumstances leading to Amarin's dispute with the FDA. These unique circumstances include, for example, that Amarin had already collected significant scientific data to support the off-label use at issue in the lawsuit; that the FDA had largely conceded that Amarin's proposed communications about Vascepa were truthful and non-misleading; and that the FDA had also conceded it had no evidence Vascepa—a fish oil product—was harmful.

Thus, to some extent, the settlement agreement reflects a pragmatic decision by the FDA to limit the potentially industry-changing impact of this unique case. Accordingly, pharmaceutical companies seeking to engage the FDA in similar disputes should be aware that, although the FDA may now be more flexible in limited cases, it is doubtful the FDA views Amarin as a dispute that fundamentally changed the drug-approval process.

Certainly nothing about the settlement (or the Amarin Court's decision) changes the core proposition that the First Amendment only protects commercial speech that is both truthful and non-misleading. The FDA clearly retains the authority to protect consumers and physicians from advertising and promotion that is false and misleading. The current FDCA, which was amended after widespread deaths due to ineffective or adulterated drugs, requires manufacturers to demonstrate their drugs are both safe and effective for the intended uses before the FDA will approve distribution. And a drug still may be deemed "misbranded" if, among other things, "its label is false or misleading; the label fails to display required information prominently; its container is misleading; or it is dangerous to health when used in the dosage, manner, frequency, or duration prescribed, recommended, or suggested on the label." Caronia, 703 F.3d at 154 n.3. Given the expansive definition of misbranding and the history of the regulations that govern drug advertising, drug manufacturers that publish false or misleading information, or information that might promote unsafe use, are still susceptible to misbranding actions. Thus, the FDA will almost certainly be on the lookout for disputes that may ultimately limit the scope of Amarin.

Finally, although the Amarin decision and settlement clearly provide some First Amendment protections to pharmaceutical companies and their employees regarding off-label promotion, what constitutes "truthful and non-misleading" information remains a distinctly gray area that will vary depending on many factors such as the drug at issue and the intended audience. As evidenced by its cautionary statements to drug manufacturers regarding the continuing concerns about misbranding, the Amarin Court clearly appreciates this reality. It is critical that pharmaceutical companies must do the same by employing precautionary measures to pre-screen promotional materials with the FDA.

In sum, how and to what extent the Amarin decision and settlement will impact pharmaceutical companies' ability to market drugs for off-label uses is difficult to predict at present. Although Amarin is indeed unprecedented, the FDA will remain vigilant in identifying off-label marketing activities, even where it might be willing to negotiate. Pharmaceutical companies and their employees should also continue to use caution regarding any advertisements or promotional activities that stray from a product's current FDA-approved labeling.

1 Amarin Pharma, Inc. v. United States FDA, 119 F. Supp. 3d 196 (S.D.N.Y. 2015).
2 The Court approved the settlement agreement on March 8, 2016.
3 United States v. Caronia, 703 F.3d 149 (2d Cir. 2012).

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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