Doctors have always had the discretion, without any federal interference, to prescribe approved drugs and medical devices for unapproved, off-label uses, and patients have been free to take them for such uses. Indeed, off-label use "is an accepted and necessary" medical practice that often represents the standard of care. Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341, 350 (2001). Although the Federal Food Drug and Cosmetic Act (FDCA) does not directly prohibit promotion of off-label uses, the Department of Justice (DOJ) and Food and Drug administration (FDA) have long attempted to prosecute, both civilly and criminally, such "off-label promotion" under the theory that drugs or devices intended for off-label use are "adulterated" and "misbranded." United States v. Facteau, 2020 WL 5517573, at *1 (D. Mass. Sept. 14, 2020) (noting that "the statutory and regulatory scheme needs to be rethought" and that the government's theory "criminalizes conduct that it is not entirely clear Congress intended to criminalize"), aff'd, 89 F.4th 1 (1st Cir. 2023), cert. denied, 145 S. Ct. 137 (2024). For the last three decades, the industry has fought back, arguing that DOJ and FDA are infringing on manufacturers' First Amendment commercial speech rights. Vanda Pharmaceuticals Inc. v. FDA1 represents the latest entry in this three-decade fight.
Vanda's First Amendment Argument
For years, Vanda Pharmaceuticals Inc. (Vanda) has argued that its drug, Hetlioz (tasimelteon), is a safe and effective treatment for jet lag. FDA has repeatedly rejected that argument. While FDA approved Hetlioz for limited sleep disorders,2 it has repeatedly demanded that Vanda provide additional evidence of Hetlioz's efficacy, including proof of clinically meaningful sleep improvement over a placebo, before it can expand its label to include treatment of jet lag disorder. In the absence of that evidence, FDA has repeatedly rejected Vanda's request for this label expansion.
As a result of FDA's refusal to approve an expanded label for Hetlioz, using the drug to treat jet lag disorder is an "off-label" use. Doctors and patients may engage in off-label use, but the FDCA and FDA regulations limit the extent to which manufacturers can promote or intend off-label use.
Despite the restrictions on off-label use, Vanda desires to distribute three peer-reviewed studies to physicians that support using Hetlioz to treat jet lag disorder, accompanied by coversheets, article summaries, and descriptive statements about the studies all generated by Vanda. It couches this desire in terms of the need for doctors to "make informed treatment decisions by consulting the cutting edge of scientific knowledge." Compl. ' 1; see also id. ' 2 ("Doctors must have the best information available to make the best medical decisions ...."); id. ' 8 ("To make the best medical judgments, doctors should have all available truthful and non-misleading information at their disposal.").
In January 2025, FDA issued new guidance on this topic titled "Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers" ("2025 FDA Guidance"). The 2025 FDA Guidance, which consolidates and revises guidance from 2009, 2014, and 2023, permits pharmaceutical and device manufactures to disseminate limited scientific or research information about unapproved uses of approved drugs or devices without running afoul of the FDCA's prohibitions against off-label promotion.3 The 2025 FDA Guidance requires that any such scientific or research information be informative, truthful, and not misleading, and present all information necessary for health care providers to understand and evaluate the strengths and weaknesses, validity, and clinical utility of the scientific information on unapproved use(s) in that specific communication. Using a collection of questions and answers, the 2025 FDA Guidance further restricts the manner in which such informative, truthful, and not misleading information can be disseminated.
Most importantly for this case, the 2025 FDA Guidance "recommends" that when disseminating scientific or research information about unapproved uses, firms state "that the safety and effectiveness of the medical product for the unapproved use has not been established." Guidance at 15. Here, if Vanda desires to distribute three peer-reviewed studies, and Vanda-generated materials about the studies, to doctors about using Hetlioz to treat jet lag disorder, then it must also advise those doctors that "the safety and...
