Danco Laboratories, LLC, v. Alliance for Hippocratic Medicine; U.S. FDA v. Alliance for Hippocratic Medicine

This case involved a challenge by anti-abortion doctors to the Food and Drug Administration’s (FDA) approval of mifepristone — a medication used in most abortions in this country. The FDA approved mifepristone over twenty years ago, finding that it is safe, effective, and medically necessary. Decades of study and practice have confirmed mifepristone’s efficacy and safety. Yet a district court in Texas and the US Court of Appeals for the Fifth Circuit issued an injunction against the FDA approval, a ruling that would have imperiled access to the drug for everyone. Our brief argued that these decisions constitute impermissible judicial overreach. They rest on self-serving anecdotal data and discredited testimony, while declining to engage with the rigorous—and plentiful— scientific data supporting the FDA’s decisions.

Permitting even part of the district court’s decision to take effect would have immediately erected unnecessary burdens to mifepristone access. Since its approval, more than 5 million people in the United States have used mifepristone for medication abortion and miscarriage management, and the two-drug medication abortion regimen approved by the FDA now accounts for 53% of all abortions in the United States. Today, with abortion access already severely restricted nationwide, mifepristone’s ready availability is critically important.

On April 21, 2023, the U.S. Supreme Court stayed the lower court decisions, ensuring that mifepristone remains available pending further litigation in the case.