Since the Supreme Court’s Dobbs ruling on June 24, 2022, four new cases have been filed in federal courts specifically regarding aspects of the FDA’s regulation of medication abortion. These challenges, some in the early stages, could affect the availability of abortion medications in the short and long term. At the heart of these cases is the FDA’s authority to approve drugs, whether courts can reverse the FDA’s decisions, and if states can impose additional restrictions beyond what the FDA requires. 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 plaintiffs in this case contend the FDA did not act within its authority and that an 1873 anti-obscenity law, the Comstock Act, prohibits the mailing of any medication used for abortion.The outcome of this case could have ramifications for access to medication abortion throughout the country, including in states where abortion is legal and protected. For the first time, the court is being asked to essentially overturn the approval of a drug, in this case one that has been safely used by more than 5.6 million people since it was approved in 2000 with a long record of safety and effectiveness. This issue brief focuses on the major claims in the AHM case, as a decision is expected soon, but many of the issues raised will also be relevant to the other abortion cases involving the FDA and its role in approving and regulating mifepristone.
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