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Food & Drug Administration v. Alliance for Hippocratic Medicine / Danco Laboratories, L.L.C. v. Alliance for Hippocratic Medicine

(U.S. Sup. Ct. Nos. 23-235, 23-236; Fifth Circuit No. 23-10362)

An association of anti-abortion doctors brought this case to challenge the FDA’s approval of mifepristone (also known by the brand name, Mifeprex), a medication used in the safest and most effective regimen of medication abortion.  The plaintiff is seeking a court order directing the FDA to withdraw its approval of mifepristone altogether, which would make it illegal to distribute the medication in the U.S., or in the alternative, to reinstate outdated and unnecessary regulations that would, among other things, require abortion patients to make an in-person trip to a clinic to obtain mifepristone, rather than obtain the medication through the mail or from a retail pharmacy.  Currently, more than 60% of abortions in the U.S. are medication abortions.  If successful, the lawsuit would dramatically reduce access to this care throughout the country.

On April 11, 2023, the Lawyering Project joined over 100 other reproductive health, rights, and justice organizations in submitting an amicus curiae brief to the Fifth Circuit.  The brief attests to the safety and popularity of mifepristone and describes the profoundly negative consequences that would result from making the medication unavailable.

On January 30, 2024, the Lawyering Project joined the American Civil Liberties Union and Center for Reproductive Rights in submitting an amicus curiae brief to the Supreme Court.  The brief details why the plaintiff’s expert witnesses are not credible and how other courts have rejected their testimony for lacking a reliable scientific basis.

Timeline and Key Documents:

March 26, 2024

The Supreme Court hears oral argument.

January 30, 2024

The Lawyering Project joins the American Civil Liberties Union and Center for Reproductive Rights in submitting an amicus curiae brief to the Supreme Court.

December 13, 2023

The Supreme Court grants certiorari, agreeing to hear the case.

August 16, 2023

The Fifth Circuit affirms the district court’s order in part and vacates it in part.  The Supreme Court’s April 23, 2023, order prevented this decision from taking effect.

April 21, 2023

The Supreme Court stays the district court’s order for the duration of the appeals process.

April 11, 2023

The Lawyering Project joins 100 other reproductive health, rights, and justice organizations in submitting an amicus curiae brief to the Fifth Circuit.

April 7, 2023

The district court enters a preliminary order staying the effective date of the FDA’s September 28, 2000, approval of mifepristone and all subsequent FDA actions related to that approval.  This order has not taken effect because of a series of temporary stays, culminating in an order entered by the Supreme Court on April 21, 2023.

November 18, 2022

The lawsuit is filed in federal district court in the Northern District of Texas.