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

by Jackson Walker

The Free Speech Clause of the First Amendment prevailed in the latest challenge to the FDA's prohibition against marketing FDA-approved drugs for off-label (or non-FDA-approved) uses. Applying the Second Circuit’s precedent-setting decision in U.S. v. Caronia, 703 F.3d 149 (2d Cir. 2012), Judge Engelmayer of the United States District Court for the Southern District of New York granted a preliminary injunction in favor of Amarin Pharma, Inc., and 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. v. U.S. Food & Drug Admin., No. 1:15-cv-03588-PAE, *49 (S.D.N.Y. August 7, 2015) (emphasis in original).

A. The Amarin Decision

Amarin manufactures Vascepa, a drug derived from an omega-3 fatty acid obtained from fish oil. Vascepa is FDA-approved to treat patients with high levels (>500 mg/dL) of triglycerides. Amarin sought approval to publish information1 regarding Vascepa's off-label use for patients with lower levels (200-499 mg/dL) of triglycerides—a use for which physicians were already regularly prescribing Vascepa. In spite of the fact that the safety and efficacy of this off-label use was supported by FDA-approved studies, the FDA warned that Vascepa "may be considered to be misbranded" under the Federal Food, Drug, and Cosmetic Act ("FDCA") if Amarin marketed it for off-label use.

Amarin preemptively filed suit against the FDA in order to prevent the FDA's prohibition against off-label promotion of Vascepa from chilling its constitutionally protected speech. Amarin argued that the FDA violated the First Amendment by prohibiting Amarin from making "completely truthful and non-misleading statements about its product to sophisticated healthcare professionals." Amarin, at *26 (quoting the Complaint filed by Amarin). The FDA responded with the argument that it could use speech as evidence of the intent (mens rea) and the act (actus rea) of misbranding. Id. at *44. It likened off-label advertising to activities such as jury tampering, insider trading, and blackmail in which speech alone, consistent with the First Amendment, is illegal. Id. at *45. The FDA further argued, among other things, that granting First Amendment protection to off-label promotion allows a manufacturer to sidestep the FDA drug approval process. Id. at *35, 49-50.

Relying heavily on, if not extending, the Second Circuit's Caronia decision, 2 the Court rejected the FDA’s arguments and ultimately held that Amarin can publish information regarding off-label use so long as it is "truthful and non-misleading." Id. at *71.3 As to the FDA's argument that off-label promotion is evidence both of the intent and the act of misbranding a drug, the court held that, as established in Caronia, the prohibition against dissemination of information about off-label use does, in fact, impermissibly prosecute the act of constitutionally protected speech. Id. at *46.4 Second, the court rejected the FDA's argument that permitting off-label promotion might eviscerate the FDA drug approval process. In this regard, the court followed Caronia's conclusion that the FDCA's ban on off-label advertising was not narrowly tailored to further the asserted government interest and, therefore, failed to satisfy the 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). Based on these conclusions, the court ultimately decided that Amarin could engage in truthful and non-misleading speech promoting the off-label use of Vascepa. Amarin, at *69

B. Impact and Takeaways from Amarin

While the Amarin decision is another significant victory for pharmaceutical companies in the conflict between the First Amendment and the FDCA, its import (as well as Caronia's) is not as simple as "the First Amendment allows off-label advertising." First, neither Amarin nor Caronia give drug manufacturers carte blanche to publish any off-label information about their products. Certainly "snake oil salesman" pitches that are untrue or misleading or that may promote unsafe usage might still be prosecuted in misbranding actions. Second, both Amarin and Caronia concern communications with healthcare professionals, who have the discretion to prescribe drugs for off-label uses, as well as the training to appreciate the risks and benefits of off-label usage. Thus, we are unlikely to see direct-to-consumer advertising for particular off-label uses because—though the claims in the advertisements might be true—they might still be considered misleading to particular audiences.

The Amarin opinion includes ample warnings reiterating the importance of taking precautions to avoid the implication of the FDA's misbranding regulations even in light of protections that may be afforded by the First Amendment. Many of the precautionary measures involve pre-screening promotional materials with the FDA prior to circulation. The Court reccomended that drug manufactuerers:

  1. Consult with the FDA regarding any off-label uses and how promotional materials can properly promote such use. The FDA's Office of Prescription Drug Promotion can provide advisory commentary and practical guidance as to the content and scope of such communications.
  2. Ensure that the appropriate disclosures are included prior to dissemination of articles from scientific or medical journals related to unapproved uses of the FDA-approved drugs, and that such disclosures adequately address the FDA's concerns.
  3. Avoid false or misleading statements regarding off-label use on marketing materials; such statements may still be prosecuted as misbranding. Inadequate directions for intended uses may also be prosecuted as misbranding by the FDA.
  4. Closely monitor data concerning the safety and efficacy of off-label uses for particular drugs. Drug manufacturers are charged with ensuring that all statements regarding off-label use are truthful and non-misleading, and this status can change rapidly due to the dynamic nature of science and medicine. As Amarin warns, "A statement that is fair and balanced today may become incomplete or otherwise misleading in the future as new studies are done and new data is acquired." Id. at *66.

While the Amarin and Caronia decisions have provided First Amendment protections for pharmaceutical companies and their employees, it is crucial that all materials advertising off-label use for FDA-approved drugs be thoroughly scrutinized before publication and distribution.

1The information Amarin sought to publish included reprints of peer-reviewed scientific publications, summaries of clinical studies concerning the promoted off-label use, and various statements and disclosures about the promoted off-label use of Vascepa. Amarin, at *53-54.

2The Second Circuit's Caronia decision also addressed the conflict between the First Amendment and the FDA's prohibition on off-label advertising. In Caronia, a drug manufacturer's sales representative successfully appealed his conviction of conspiracy to introduce a misbranded drug into interstate commerce. Applying the principle of constitutional avoidance—since off-label promotion is not an explicit violation of the FDCA—the Second Circuit found that the FDCA could not be interpreted to prohibit truthful off-label promotion of a drug without violating the First Amendment. Id. at 162. The Caronia decision, in turn, held that "the government cannot prosecute pharmaceutical manufacturers and their representatives under the FDCA for speech promoting the lawful, off-label use of an FDA-approved drug." Id. at 169.

3Notably, the Amarin decision applies "across-the-board to all truthful and non-misleading promotional speech." Id. at *51 (referencing Caronia, at 149). Even before Amarin, drug manufacturers could disseminate off-label information in limited circumstances such as providing limited responses to unsolicited requests for off-label information on prescription drugs. Under the Amarin decision those limited exceptions seem to no longer be of consequence.

4The court recognized, however, that truthful speech might be evidence of the intent to commit misbranding where the act at issue is promotional activities other than truthful speech; e.g., payments to doctors as a reward for prescribing a drug for an off-label use. Id. at *52.


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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