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June 2, 2023

The Mifepristone Case and the Legitimacy of the FDA

Author Affiliations
  • 1Yale Law School and Yale School of Medicine, Yale University, New Haven, Connecticut
JAMA. 2023;329(24):2121-2122. doi:10.1001/jama.2023.8712

In April, for what appears to be the first time in history, a federal court in Texas1 invalidated the US Food and Drug Administration’s (FDA) approval of a drug—after more than 20 years on the market with a strong safety and efficacy record. The drug, mifepristone, blocks progesterone and has a range of uses, from treatment for Cushing syndrome to, when used together with misoprostol, ending a pregnancy and managing miscarriage. The 2-drug regimen is used for more than 50% of abortions in the US.

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2 Comments for this article
FDA Authority
Richard Kuntz, JD | Private Practice
A key aspect of the decision is that FDA approval was based on the portion of the statute giving it authority to approve drugs for the “treatment of disease.” The court found that pregnancy was not a “disease.”
Some Pregnancies Are a "Disease"
Nancy Woolley, R.N., JD | Retired
Though many (most?) pregnancies are not a 'disease' as that term is usually understood, there are pregnancies that are diseased and if left untreated and allowed to continue, would cause great harm or even death. These cases are best treated by the termination of the diseased pregnancy, and the most efficacious manner of doing so is with medication such as mifepristone.