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New Generic Abortion Pill Approval Sets Off GOP Senate Push, Louisiana Court Challenge

Agencies say the approval was legally required, with a safety review in progress.

Overview

  • Fifty-one Republican senators led by Lindsey Graham urged HHS and the FDA to reevaluate the new generic mifepristone, suspend generic approvals, reinstate in‑person dispensing, restrict mail-order distribution, and withdraw pharmacy guidance.
  • The FDA quietly approved a second generic mifepristone from Evita Solutions late last month, with officials emphasizing that generic approvals are constrained by statute and do not constitute an endorsement.
  • Louisiana filed a federal suit in the Western District of Louisiana seeking to restore pre‑2023 REMS, bar mail-order dispensing, and invoke the Comstock Act, citing state abortion laws and alleging hundreds of mail-order abortions monthly in 2024.
  • HHS and FDA officials say a safety review of mifepristone is underway, with the White House noting the law tightly limits the agency’s discretion when a generic drug demonstrates required equivalence.
  • Anti-abortion advocates amplified accounts of alleged coercive use of abortion drugs and highlighted interstate enforcement clashes, as GOP lawmakers and groups pressed for swift reinstatement of in‑person requirements.