FDA’s delayed mifepristone reviews spark Louisiana lawsuit over mail-order abortions

In Louisiana v. FDA, the state challenges the agency’s 2021 revision of the mifepristone Risk Evaluation and Mitigation Strategy, which eliminated the requirement that the drug be dispensed in person. The change allowed a California abortion provider to mail the medication to a Louisiana woman, Rosalie Markezich, whose boyfriend administered it, leading to the loss of her unborn child. The FDA argues that shield laws protecting providers, not its own regulations, caused the harm and that Louisiana lacks standing to sue.

Danco, the manufacturer, insists the state must first pursue an unsuccessful petition with the FDA before seeking judicial relief. Past citizen petitions on mifepristone have languished for years, raising doubts about the efficacy of another petition.