DOJ’s Expansive Reading of the FDCA Sparks State Resistance and Raises New Criminal Exposure for Healthcare Providers

We previously reported on the September 9, 2025 decision by the U.S. District Court for the District of Massachusetts granting Boston Children’s Hospital’s (BCH) motion to quash an administrative subpoena issued by the Department of Justice (DOJ). See Memorandum of Decision, In re Administrative Subpoena, No. 1:25-mc-91324-MJJ (D. Mass. Sept. 9, 2025).

This alert provides an important update: a coalition of states has now filed an amicus brief backing BCH’s position and further challenging the government’s expansive inquiry into gender-affirming care (“GAC”).

Recent Filing by States

A group of states submitted a brief that was accepted by Judge Myong J. Joun in connection with the subpoena litigation. The states argue that the government’s request for BCH’s records is not merely a fraud or off-label investigation under the False Claims Act (FCA) or the Food, Drug & Cosmetic Act (FDCA), but rather a transparent effort to use federal investigative tools to interfere with lawful, state-protected gender-affirming care.

Key points raised in the states’ brief include:

• The subpoena’s overbroad scope — covering patient identifiers, medical records, personnel files, and communications with pharmaceutical companies — far exceeds any reasonable FCA or FDCA purpose.
• The DOJ’s interpretation of the FDCA, as applied here, would expose not only GAC providers but a “wide variety of doctors” to potential criminal liability for routine, evidence-based medical practices.
• Without clear limits, the government’s approach could chill legitimate care and threaten state authority to regulate medical practice — the states’ brief asserts their interest in protecting both patients and providers in their jurisdictions from such government intrusion.
• The brief specifically warns that if the DOJ’s approach is accepted, entire fields of medicine could be at risk — not just transgender care.

This filing was joined by Massachusetts, California, Colorado, Connecticut, Delaware, District of Columbia, Illinois, Maine, Maryland, Minnesota, Nevada, New Jersey, New Mexico, New York, Oregon, Rhode Island, Vermont, Washington and Wisconsin which underscores a unified defiance of what they view as an overreaching federal agenda. Indeed, the number of participating states signals growing willingness among jurisdictions to intervene in defense of care providers and to resist federal overreach in areas traditionally governed by state medical regulation.

Criminal Implications for Providers

The states’ brief echoes Judge Joun’s finding that the subpoena was “motivated by bad faith” and constituted a “fishing expedition,” not a legitimate fraud investigation. They argue the DOJ’s true motive is policy-driven — namely, to restrict gender-affirming care under the guise of fraud enforcement.

The brief argues that if DOJ’s theory of FDCA and FCA liability for off-label drug use or novel treatment protocols is upheld, the exposure is not limited to GAC providers. Physicians in oncology, pediatrics, psychiatry, and other fields routinely rely on off-label uses that could fall within the DOJ’s broadened interpretation of “fraudulent” medical conduct. Moreover, States with statutory protections for GAC — including Connecticut’s gender-affirming care shield law (Conn. Gen. Stat. § 52-146x) — now face direct conflict between federal subpoenas and state confidentiality obligations, complicating compliance strategies for providers.

DOJ’s Expansive Misbranding Theory Under the FDCA

The states’ brief also points out that the DOJ’s position suggests that medical providers could be liable under the FDCA’s prohibition on distributing “misbranded” medications merely for explaining an off-label use of an already approved drug or device to patients. Under the FDCA, a drug or device is considered “misbranded” if its labeling is “false or misleading.” 21 U.S.C. § 352(a)(1). The statute prohibits the introduction or delivery for introduction into interstate commerce of any “adulterated or misbranded” drug or device. 21 U.S.C. § 331(a). Historically, both the FDA and DOJ have construed these provisions as applying primarily to manufacturers, distributors, and their agents—that is, firms engaged in the commercial promotion or marketing of drugs—not to independent health-care providers who prescribe or administer approved medications.

In its recent filing, however, DOJ advances a markedly broader interpretation. Relying on a declaration from an agency official, the Department suggests that health-care providers themselves could be subject to criminal liability for “misbranding” merely by explaining an off-label use of an approved drug or device to a patient. The government reasons that because the FDCA defines “labeling” broadly to include materials that “supplement” or “explain” a drug—such as instruction sheets or explanatory handouts—a provider who supplies such materials could be deemed to have “distributed” a misbranded drug if those materials are viewed as misleading or as promoting an unapproved use.

This theory departs sharply from longstanding federal enforcement practice. Neither FDA nor DOJ has previously applied § 331(a) to impose misbranding liability on a physician or nurse acting solely in a clinical, non-commercial capacity—particularly where no manufacturer sponsorship or promotional activity is involved. If accepted, DOJ’s interpretation would represent a significant expansion of federal criminal exposure for medical professionals, effectively inserting federal oversight into routine provider–patient communications.

Expansion of Provider Liability for Off-Label Use

The DOJ’s misbranding theory is further compounded by its assertion that health-care providers themselves may face criminal liability simply for purchasing, storing, or administering FDA-approved drugs for off-label uses. To reach that conclusion, DOJ constructs a multi-step theory under which (1) a drug used for an unapproved indication is treated as a “new drug,” (2) its distribution constitutes a federal crime, and (3) any provider who purchases, stores, or administers it is part of the “chain of distribution.” This interpretation departs from both statutory text and decades of established practice, which have limited misbranding and distribution liability to manufacturers, distributors, and their agents, not independent health-care professionals. If accepted, DOJ’s theory would make ordinary medical activities—such as hospital pharmacies acquiring or clinicians administering off-label medications—potentially criminal acts under federal law.

That position is flatly inconsistent with the FDCA itself, which expressly safeguards the discretion of licensed medical professionals to use approved drugs and devices for off-label purposes within a legitimate provider–patient relationship. See 21 U.S.C. § 396 (“Nothing in this chapter shall be construed to limit or interfere with the authority of a health care practitioner to prescribe or administer any legally marketed device to a patient for any condition or disease within a legitimate health care practitioner-patient relationship.”). Courts have long recognized that such practices are lawful and medically necessary, particularly in fields like oncology, pediatrics, and psychiatry, where off-label use is both routine and vital. See, e.g., United States v. Facteau, 89 F.4th 1, 15 (1st Cir. 2023); In re Celexa & Lexapro Mktg. & Sales Pracs. Litig., 915 F.3d 1, 5 (1st Cir. 2019). By treating physicians as “distributors” merely for administering approved medications or devices to patients, DOJ’s theory would upend accepted medical practice, undermine patient care, and contravene the FDCA’s longstanding recognition of the legality of off-label prescribing by duly licensed professionals.

Takeaways

In practical terms, the DOJ’s approach could expose physicians who prescribe and discuss off-label treatments to misbranding prosecution simply for providing patients with written materials about their care. Such a reading risks muting clinical dialogue, undermining informed consent, and constraining legitimate medical judgment in areas where off-label use is both common and medically appropriate.

Although such prosecutions would represent a significant expansion of federal criminal law, the mere existence of this theory can have a chilling effect on providers, researchers, and hospitals engaged in any off-label practice. Providers should understand that the DOJ’s investigative focus may evolve from civil enforcement (subpoenas and FCA actions) into criminal inquiries if records or testimony suggest intentional misrepresentation or concealment.

Next Steps for Providers

Given the evolving landscape, health-care providers offering gender-affirming services (and potentially other care subject to off-label or novel use scrutiny) should consider the following actions:

• Monitor Subpoena Threats and Timing: Receipt of an administrative subpoena from DOJ (or its investigative components) should trigger an immediate evaluation of scope, relevance, and legitimacy.
• Engage Experienced Counsel Promptly: Legal counsel familiar with FCA, FDCA, administrative subpoenas and health-care privacy laws can help shape strategic responses, including motions to quash or narrow.
• Preserve Documents Safely: Even when contesting a subpoena, providers should ensure appropriate document preservation to avoid spoliation risk.
• Evaluate Privacy and State Law Impacts: Especially in jurisdictions with statutory protections for gender-affirming care or patient confidentiality (such as Connecticut’s shield statute, Conn. Gen. Stat. § 52-146x), providers must balance state-law confidentiality obligations with federal investigative demands.
• Review Practice and Compliance Protocols: Given the DOJ’s expanded enforcement focus (including off-label use, billing codes, communications between providers and pharma), providers should audit their documentation, consent processes, billing practices and off-label drug use policies.

Bottom Line

The states’ amicus brief marks a significant escalation in the legal battleground surrounding gender-affirming care and federal investigative authority. For providers, the important takeaway is that administrative subpoenas in this context are not solely about fraud or off-label use — they may reflect broader policy objectives and could have far-reaching implications across the healthcare sector. Timely legal response, careful preservation of records, and strategic review of practice operations are essential.

As new developments arise, we will continue to update our Dobbs Decision Resource Center. In the meantime, please contact one of the lawyers in Shipman’s Health Law practice group if you have questions about this ever-changing legal landscape.