Challenges to the FDA’s Approval of Medication Abortion Pills Could Curtail Access Throughout the United States

In anticipation of a ruling in a case with enormous implications for access to medication abortion in the United States, a new KFF brief explains the impact of this case, and others filed in federal courts, involving the FDA’s regulation of medication abortion. The case that has gotten the most attention recently is Alliance for Hippocratic Medicine (AHM) v. FDA, filed in November 2022, a challenge to the FDA’s decision to approve mifepristone (the first medication taken as part of the medication abortion drug regimen) and to include misoprostol in the medication abortion regimen. The outcome of AHM v. FDA, along with the other challenges, could have ramifications for access to medication abortion throughout the country, including in states where abortion is legal and protected. The outcome could also potentially have broader implications for the FDA’s authority in regulating drugs.

Read the brief, “Legal Challenges to the FDA Approval of Medication Abortion Pills,” which focuses on the major claims in the AHM case. Many of the issues raised in the brief will also be relevant to the other abortion cases involving the FDA and its role in approving and regulating mifepristone.