Potential ‘Redefinition of Enforcement Boundaries’: Attorneys

Four Hogan Lovells attorneys say that recent Department of Justice (DoJ) subpoenas and the so-called Hsiao Declaration “signal a potential redefinition of enforcement boundaries under the Federal Food, Drug, and Cosmetic Act (FFDCA). By asserting that off-label prescribing may itself constitute an FFDCA violation and that scientific exchange could evidence conspiracy, DoJ departs from decades of precedent that shielded medical practice and non-promotional communications,” the attorneys write in an online analysis.

They say that if the theory is sustained, it could expose healthcare providers and manufacturers to heightened scrutiny for routine prescribing and lawful information sharing, creating significant compliance risks and uncertainty across therapeutic areas, and not solely gender-affirming care.

The subpoenas have gone to healthcare providers seeking patient-identifying records on gender care. The attorneys write that although recent court rulings have rejected the DoJ’s attempt to compel patient-identifying records and reaffirmed that the FFDCA does not regulate medical practice, subpoenas targeting manufacturer–provider communications remain enforceable. “Stakeholders should review internal policies governing off-label discussions, scientific exchange, and documentation practices to mitigate exposure,” they say. “Manufacturers and providers should also monitor appeals closely, as a shift in enforcement posture could reshape the regulatory landscape and blur long-standing distinctions between commerce and care.”

The “Hsiao Declaration” was issued by Julie Hsiao, an acting director in the DoJ consumer protection branch. The attorneys say the declaration is premised on a major departure from well-established theories of the healthcare provider practice of medicine exemption for off-label prescribing. They say Hsiao claims that although doctors are permitted to prescribe an FDA-approved drug for an unapproved use, such prescribing may warrant investigation because it may provide evidence of FFDCA violations. She further asserts that healthcare providers who prescribe certain drugs off-label may be subject to FFDCA liability. Thus, Hsiao says 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.”

The attorneys offer these 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 providers. 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: Healthcare 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 should be aware of state-based protections for patients and certain types of care.

·  Collaboration and Compliance: Drug manufacturers and providers should ensure that interactions remain within the bounds of scientific exchange.