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

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altogether, which would make it illegal to distribute the medication in the U.S., or in the alternative, to reinstate outdated and unnecessary regulations that would, among other things, require abortion patients to make an in-person trip to a clinic to obtain mifepristone, rather than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.

On June 13, 2024, the Supreme Court ruled, in a unanimous opinion, that the plaintiffs lack standing to bring the lawsuit. The Court found that the plaintiffs failed to demonstrate that the FDA’s actions concerning mifepristone had or would cause them a legally significant injury. The ruling means that the lower court must dismiss the claims brought by these plaintiffs, and that access to mifepristone remains unchanged for now.  However, the case will return to the district court, where the states of Idaho, Kansas, and Missouri seek to continue the litigation.  The district court previously allowed those states to intervene as plaintiffs.

The Supreme Court rules that the original plaintiffs lack standing to maintain the lawsuit.

The Supreme Court hears oral argument.

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

The District Court grants Missouri, Idaho and Kansas’ motion to intervene in the case.

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

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.

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

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

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.

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