Using FDA Law to Threaten Medical Practice

Authors

• Lewis A. Grossman, American University, Washington DC
• Nathan G. Cortez, Southern Methodist University, Dedman School of LawFollow
• Patricia J. Zettler, Ohio State University, Moritz College of Law

ORCID (Links to author’s additional scholarship at ORCID.org)

Lewis A. Grossman: https://orcid.org/0000-0001-6373-6419

Nathan G. Cortez: https://orcid.org/0000-0002-2536-1297

Abstract

Though recent subpoenas from the U.S. DOJ target providers of gender-affirming care, the legal arguments behind them could affect physicians prescribing off-label treatment for any reason.

Publication Title

The New England Journal of Medicine

Document Type

Article

Keywords

healthcare access, patients, puberty, gender-affirming care, FDA approval, federal regulation, off-label drug use

Recommended Citation

Lewis A. Grossman, Nathan G. Cortez & Patricia J. Zettler, Using FDA Law to Threaten Medical Practice, 394 New Eng. J. Med. 524 (2026), https://doi.org/10.1056/NEJMp2516086