DOJ Subpoenas, Scientific Exchange, and Deference to Doctors – What We Are Watching

Introduction

In early 2025, President Trump issued Executive Order 14187 (EO), “Protecting Children from Chemical and Surgical Mutilation,” demanding an end to gender-affirming care. The Attorney General then issued a memorandum in April 2025 instructing U.S. Attorneys to investigate female genital mutilation, and the Consumer Protection Branch to investigate medical providers and pharmaceutical companies for violations of the Food, Drug and Cosmetic Act (FDCA) for engaging “in misbranding by making false claims about the on- or off-label use of puberty blockers, sex hormones, or any other drug used to facilitate a child's so-called gender transition." The memorandum led to more than 20 subpoenas to hospitals and health care providers (HCPs) seeking records and documents related to gender affirming care, including personal identifying information such as social security numbers and birth dates.

Parents of patients treated at one of the subpoena recipients, the University of Pittsburgh Medical Center (UPMC), moved to quash the subpoena. The parents argued that the government’s attempt to use the FDCA to criminalize or regulate medical practice is unprecedented and unsupported by law, and that once a drug is approved, HCPs may prescribe it for unapproved uses when medically appropriate. The parents also argue the DOJ’s position confuses the distinct legal obligations of manufacturers, who are prohibited from going beyond scientific exchange and advertising or promoting their drugs for unapproved uses, with those of physicians, who are allowed to prescribe drugs for unapproved, or “off-label” uses.

The DOJ’s position, detailed in a declaration from the Acting Director Lisa Hsiao, signals a significant shift in DOJ policies around enforcement involving drug treatments. (In Re 2025 UPMC Subpoena, Civil Action No. 2:25-mc-01069-CB, DI 27-1).

Challenges to the subpoenas are making their way through the courts. At least one has rejected DOJ’s unprecedented legal theory and quashed a similar subpoena’s demands for patient-identifying medical records and HCP care information. Although the order limits DOJ’s ability to enforce those requests against one hospital, the ruling may be appealed, and DOJ might apply that ruling only to one subpoena recipient. Importantly, the order does not address the subpoena’s requests for manufacturer communications to HCPs about their drugs. Thus, we believe that these matters could become important in assessing the Trump Administration’s views of long-standing FDA precedent.

The Hsiao Declaration

The Hsiao Declaration is premised on a major departure from well-established theories of the HCP practice-of-medicine exemption with respect to off-label prescribing under the FDCA. Specifically, Ms. Hsiao asserts that although “physicians are permitted to prescribe an FDA-approved drug for an unapproved use, such prescribing may warrant investigation because it may provide evidence of FDCA violations. Also… prescribing for unapproved uses can itself involve FDCA violations, for example, where the physician is engaged in the distribution or labeling of an unapproved drug.” Hsiao Declaration at 12.

Hsiao then asserts that HCPs who prescribe certain drugs off-label may be subject to FDCA liability. She asserts that providers of gender affirming care are failing to provide adequate labeling for off-label uses, and are “actively deceiving patients and parents with false claims and statements regarding the drugs’ effectiveness or alternatives, and misrepresented . . . risks.” Hsiao Declaration at 12. The subpoena in turn seeks information about prescribing, billing, or marketing practices and which actors have authority to engage in such activities at UPMC, as well as documents showing relationships between manufacturers or distributors and providers that may be probative of intent to conspire to use products off-label. The subpoena also seeks patient-level information, including clinical justification, informed consent, and disclosure of off-label use that may show physicians downplayed or concealed risks related to those uses. Hsiao Declaration at 14.

This approach conflates “distributors” (manufacturers, wholesalers, pharmacies) with “dispensers” (licensed practitioners), a distinction recognized in 21 USC 353(b) and case law. The government’s theory represents a major deviation from how the practice-of-medicine exemption has been understood with respect to off-label prescribing under the FDCA. In 21 USC 396, Congress made clear that nothing in the FDCA “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.” See also Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001). The Acting Director’s declaration appears oblivious to this statutory provision and case law applying the provision.

Conspiracy Through Scientific Exchange: A New Enforcement Theory

The declaration also contradicts long-standing understandings of “scientific exchange.” Specifically, the Hsiao Declaration posits that the subpoena seeks evidence of a conspiracy that may exist between manufacturers and HCPs to promote off-label use, with “scientific exchange” serving as that evidence. Traditionally, FDA guidance has protected scientific exchange, i.e., the non-promotional sharing of scientific information. The DOJ’s theory may mark a significant shift, as limiting scientific exchange directly contradicts recent FDA guidance expanding manufacturers’ ability to disseminate “scientific information on unapproved use(s) of the firm’s approved/cleared medical products to health care providers.” The guidance, “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products” (“SIUU Guidance”), provides a detailed framework for lawful scientific exchange, and explicitly states “FDA does not intend to use the firm’s dissemination of such communication standing alone as evidence of a new intended use.”

We have previously analyzed online here how the SIUU Guidance allows manufacturers to provide certain source publications to HCPs that discuss evidence relating to unapproved uses of approved products. FDA will not seek to use such communications as evidence of intent to promote a new intended use so long as the information is truthful and not misleading, the studies are scientifically sound, and certain disclosures are included. Conversely, Acting Director Hsaio’s declaration argues that the requested documents relating to relationships with drug manufacturers or distributors may “support a FDCA theory (including conspiracy) involving unlawful off-label promotion.” Hsiao Declaration at 13. Of course, DOJ has historically assessed communication between manufacturers and HCPs to determine whether they fall under scientific exchange principles. They have not done so, however, by asserting that HCPs might be in a potential conspiracy with the manufacturers or that they might be acting as distributors of drug products. Both potentially represent a wholesale deviation from FDA’s longstanding approach to the permissibility of such communications.

Recent Rejection of DOJ’s Theory of FDCA Liability

In a detailed ruling issued on November 21, 2025, Judge Kearney (E.D. Pa.) held that DOJ lacks statutory authority to compel the production of personally identifying patient records and HCP care information, finding such materials “bear no relevance” to its FDCA investigation. The court also rejected Ms. Hsiao’s interpretation of HCP liability under section 331 as a misstatement of the statute’s scope.

The decision reinforces a key principle: Congress regulates commerce, not care. The FDCA governs drug manufacturing and distribution, not the practice of medicine, which remains under state authority. Off-label prescribing is lawful and beyond the FDCA’s reach. The court further ruled that “labeling” does not encompass clinical documents such as medical records, informed consent forms, or physician–patient communications.

This marks the third public ruling against DOJ subpoenas; DOJ has appealed two prior losses and is expected to appeal here. Notably, the order does not affect subpoena requests for manufacturer communications to HCPs, including “scientific exchange,” which remain enforceable. We are still awaiting a decision in the UPMC case.

Key Takeaways and Recommendations

• Legal Uncertainty: The DOJ’s evolving theories, especially regarding conspiracy evidenced by scientific exchange, could represent a significant shift from precedent and create significant uncertainty for manufacturers, distributors, and HCPs. Of course, we don’t know whether the declaration means that shift is limited to drugs used for gender-affirming care or might extend to other off-label uses. Drug manufacturers, in particular, and providers should closely monitor developments and consider reviewing internal policies on scientific exchange and off-label communication.
• Protecting Scientific Exchange: Stakeholders should continue to advocate for clear regulatory boundaries that protect legitimate scientific exchange, consistent with FDA guidance and judicial precedent.
• Patient Privacy: Health care providers should be vigilant in protecting patient privacy and challenging overly broad government demands for patient information, especially where the legal basis for such demands is contested. Providers should not assume compliance is mandatory and be aware of state-based protections for patients and certain types of care.
• Collaboration and Compliance: Drug manufacturers and HCPs should ensure that interactions remain within the bounds of scientific exchange.
  
  

Authored by Meredith Manning, Sally Gu, Bryan Walsh, and Katie Kramer