Alliance for Hippocratic Medicine v. FDA

Update: The U.S. Supreme Court ruled on June 13, 2024, that anti-abortion plaintiffs suing the FDA did not have standing to bring the case. The ruling allows the widely used abortion medication, mifepristone, to remain accessible through telemedicine and pharmacies—distribution permitted under the FDA’s recent actions to expand access to the drug.

Medication abortion is the most commonly used method of abortion in the United States, accounting for more than half of all abortions.  Mifepristone is part of a two-drug regimen for medication abortion and was first approved by the U.S. Food and Drug Administration in 2000.

Since its approval, the drug has established a well-documented safety record, as demonstrated by its real-world use by more than five million people as well as hundreds of additional high-quality studies.  

This lawsuit—filed by anti-abortion advocates against the FDA and the U.S. Health and Human Services (HHS) in November 2022—challenges the FDA’s initial approval of mifepristone as well as its more recent actions to increase access to the drug. If the lawsuit succeeds, access to the most common medication abortion regimen used in the U.S. would end across the country—even in those states where abortion rights are protected. 

The Center for Reproductive Rights and its movement partners have submitted amicus briefs in this case supporting the FDA’s approval of the medication. Leading pharmaceutical companies, medical and health organizations, members of Congress, government officials, rights and justice groups, and other experts have also submitted amicus briefs in support of the FDA.

Here’s a snapshot of case rulings:

• A federal district court in Texas issued a decision on April 7, 2023, attempting to block the long-standing FDA approval of mifepristone. If allowed to take effect, it would be a devastating blow to abortion access across the country.
• The U.S. Department of Justice appealed the decision on April 10, 2023, to the Fifth Circuit Court of Appeals. 
• On April 12, 2023, the Fifth Circuit issued a ruling largely refusing to block the federal district court’s order and attempting to reinstate burdensome restrictions from pre-2016.
• The Department of Justice announced April 13, 2023, that it would seek emergency relief from the U.S. Supreme Court and filed an emergency application with the Court the following day.
• On April 14, 2023, the U.S. Supreme Court issued a temporary stay through April 19, 2023, preventing the district court’s order from taking effect. On April 19, the Court extended its stay until Friday, April 21, 2023, at 11:59 p.m.
• On April 21, 2023, the Supreme Court granted a stay of the lower court decision, leaving mifepristone on the market while the case proceeds at the Fifth Circuit Court.
• Oral arguments at the Fifth Circuit were held May 17, 2023.
• On August 16, 2023, the Fifth Circuit Court of Appeals ruled to reinstate burdensome pre-2016 restrictions on mifepristone, but not to remove the drug from the market. Due to the U.S. Supreme Court’s April 21 order, mifepristone will remain available under current regulations while the case continues.
• On September 8, 2023, the U.S. Department of Justice filed a writ of certiori to the U.S. Supreme Court asking it to review the August 16 ruling by the Fifth Circuit.
• On December 13, 2023, the U.S. Supreme Court agreed to review the case.
• The U.S. Supreme Court announced on January 29, 2024, that it would hear oral arguments on March 26, 2024.
• Oral arguments were held March 26, 2024, with a ruling expected before the end of the Court’s term in June or July. Listen to the audio replay here.
• On June 13, 2024, the U.S. Supreme Court ruled that anti-abortion plaintiffs suing the FDA did not have standing to bring the case. The ruling allows the widely used abortion medication, mifepristone, to remain accessible through telemedicine and pharmacies—distribution permitted under the FDA’s recent actions to expand access to the drug. Read the Court’s ruling here.