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

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.

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Publication Details

Journal
UNC Libraries
Published
2025-04-01
DOI
https://doi.org/10.17615/hqq3-w958
Primary Topic
Reproductive Health and Contraception
Type
article
Field-Weighted Citation Impact
0.00
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article

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

Juan M. Hincapie‐Castillo, Michele Jönsson Funk
UNC Libraries
Reproductive Health and Contraception
article

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

Juan M. Hincapie‐Castillo, Michele Jönsson Funk
article en

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.

UNC Libraries
University of North Carolina at Chapel Hill (US)
Openalex Percentile: Top 53%
Reproductive Health and Contraception
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Mifepristone and the courts: The thread that could unravel regulation of drugs in the United States — Juan M. Hincapie‐Castillo, Michele Jönsson Funk · UNC Libraries (2025) | TGRS Research Map | TGRS