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# Justice Petitions Supreme Court Over Mifeprex
- URL: https://www.fdaweb.com/justice-petitions-supreme-court-over-mifeprex/
- Published: 2023-09-11T12:00:00.000Z
- Updated: 2026-09-14T18:55:29.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155289

The Department of Justice has [petitioned](https://newjerseymonitor.com/wp-content/uploads/2023/09/USFDA-et-al.-v.-Alliance-for-Hippocratic-Medicine-et-al.-Petition.pdf?ref=fdaweb.com) the U.S. Supreme Court asking it to reverse last month’s decision ([see earlier story](https://www.fdaweb.com/abortion-drug-can-remain-on-market-appeals-court/)) by the Fifth Circuit Court of Appeals that would restrict how the abortifacient drug Mifeprex (mifepristone) is used by, and distributed to, patients. The government’s petition was filed late 9/8, the same day Danco Laboratories, which distributes the drug, filed a similar petition ([see story](https://www.fdaweb.com/danco-seeks-high-court-abortion-drug-review/)). 

In its writ of certiorari, the Justice Department contends the Fifth Circuit “erred in holding that the respondent associations have standing based on what it viewed as a statistical probability that some of their unidentified members might be asked to treat women who are prescribed mifepristone and who then suffer an exceedingly rare serious adverse event. This Court has emphatically rejected that statistical approach to associational standing, explaining that it would ‘make a mockery” of Article III.’”

Additionally, the government said the appeals court erred in holding that FDA’s 2016 and 2021 mifepristone approval actions were arbitrary and capricious. “FDA’s actions were supported by an exhaustive review of a record including dozens of scientific studies and decades of safe use of mifepristone by millions of women in the United States and around the world,” it says. “The Fifth Circuit swept aside the agency’s expert judgments based on novel requirements that have no basis in the FDCA \[Food Drug & Cosmetic Act\] or the Administrative Procedure Act.”