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# Abortion Drug Can Remain on Market: Appeals Court
- URL: https://www.fdaweb.com/abortion-drug-can-remain-on-market-appeals-court/
- Published: 2023-08-16T12:00:00.000Z
- Updated: 2026-09-14T18:50:50.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155117

The Fifth Circuit Court of Appeals has ruled that the abortion drug mifepristone can remain on the market while litigation continues, but it should be available under the conditions for use that existed in 2016 until final judgment. In 2016, FDA approved a supplemental NDA that removed several restrictions on the drug's use in a move to make it easier for patients to obtain and use. Additional access restrictions were removed in subsequent years, including in 2021 when the agency permitted mail order distribution.

In its [8/16 ruling](https://storage.courtlistener.com/recap/gov.uscourts.ca5.213145/gov.uscourts.ca5.213145.506860229.1.pdf?ref=fdaweb.com), the three-judge panel voted 2 to 1 to vacate Texas federal judge **Matthew Kacsmaryk’**s earlier nationwide ban on mifepristone ([see earlier story](https://www.fdaweb.com/mifeprex-judge-damns-fda-for-worse-abortion-outcomes/)), stating that it is “barred by the statute of limitations.” The case is now set up for a likely review by the U.S. Supreme Court. For now, the appeals court notes that access to mifepristone is unchanged due to an earlier Supreme Court order that put the lower court's ruling on hold until a final decision is handed down.

In April, the Supreme Court granted FDA a stay of Kacsmaryk’s mifepristone ban while it was appealed to the Fifth Circuit. FDA’s [appeal](https://www.supremecourt.gov/DocketPDF/22/22A902/263491/20230414103258942%5FAlliance%20for%20Hippocratic%20Med%20%20application.pdf?ref=fdaweb.com), filed by the Department of Justice, “concerns unprecedented lower court orders countermanding FDA’s scientific judgment and unleashing regulatory chaos by suspending the existing FDA-approved conditions of use for mifepristone,” the government said. Approved in 2000, FDA has maintained its scientific judgment “across five presidential administrations, and it has modified the original conditions of mifepristone’s approval as decades of experience have conclusively demonstrated the drug’s safety,” it contended.

Meanwhile, HHS secretary **Xavier Becerra** is on record supporting a high court review “as we vigorously fight to defend the FDA’s independent, expert authority to review, approve, and regulate a wide range of prescription drugs. We are confident the law is on our side and remain focused on prevailing in court. Mifepristone remains approved and available as this case winds through the courts. We will never stop fighting to preserve women’s rights to access the health care they need and Americans’ rights to access safe and effective medicine.”

Additionally, the drug industry is supporting FDA’s authority. Pharmaceutical Research and Manufacturers of America earlier reiterated its [amicus brief](https://phrma.org/resource-center/Topics/FDA/PhRMA-Files-Amicus-Brief-with-US-Supreme-Court-in-Support-of-FDA?ref=fdaweb.com) in the matter, stating that “Congress gave the FDA the authority to determine whether a medicine is safe and effective for patients to use. Allowing the courts to second-guess a decision by the FDA to approve a medicine would create significant uncertainty and harm for manufacturers, patients and physicians. We will remain engaged to help ensure the concerns of our members are heard as the legal process unfolds.”