Overview

• In a letter led by Sen. Lindsey Graham, 51 Republican senators urged regulators to suspend new generic mifepristone approvals, fold generics into a REMS review, reinstate in-person dispensing, pause distribution as an "imminent hazard," and withdraw pharmacy-dispensing guidance.
• The FDA recently cleared a mifepristone generic from Evita Solutions after determining it is bioequivalent to the brand-name drug under the Food, Drug, and Cosmetic Act.
• HHS and the FDA have highlighted an ongoing safety review of mifepristone, while agency officials emphasize statutory limits on denying or delaying a lawfully demonstrated generic.
• Louisiana filed suit in federal court seeking to restore pre-2023 REMS, require in-person pickup, and block interstate mail-order distribution of mifepristone.
• The fight centers on telehealth prescribing, pharmacy distribution, and state enforcement, with Louisiana having classified mifepristone and misoprostol as controlled substances in 2024.