Work

Mifepristone and the courts: The thread that could unravel regulation of drugs in the United States

Year: 2025

Type: article

Abstract: As a result of recent judicial actions threatening the authority of the Food and Drug Administration (FDA), the future of pharmaceutical regulation in the United States (US) is uncertain. In response to the US Supreme Court's federal reversal on abortion rights in June 2022, there has been a flurry of conflicting litigation at the state-level aimed at preserving or limiting abortion access depending on the political inclination of the local governments. Alliance for Hippocratic Medicine v. FDA is a case against the regulatory Agency that seeks to restrict abortion by preventing access to mifepristone. This medicine was first approved by the FDA in 2000 and it is indicated to end an intrauterine pregnancy under restrictions to assure safe use. The plaintiffs argued that mifepristone should not have been initially approved, claiming that the FDA review of evidence for safety and efficacy was inadequate.

Source: Carolina Digital Repository (University of North Carolina at Chapel Hill)

DOI: 10.17615/hqq3-w958

Authors: Funk, Michele Jonsson, Hincapie‐Castillo, Juan M.

Institution: University of North Carolina at Chapel Hill

Language: English

Topic: Reproductive Health and Contraception

Subfield: Public Health, Environmental and Occupational Health

Field: Medicine

Domain: Health Sciences

SDGs: Peace, justice, and strong institutions, Good health and well-being

Open Access status: green

Funders: U.S. Food and Drug Administration, Takeda Oncology