Risk Evaluation and Mitigation Strategies

A federal judge ruled that the FDA's 2023 restrictions on mifepristone, a drug used for early pregnancy termination, were not sufficiently justified. The restrictions, challenged by abortion providers in Kansas, Montana, and Virginia, require special certification for pharmacies and clinicians and risk acknowledgment forms. A similar case in Hawaii had previously reached the same conclusion.

A federal judge ruled that the FDA's 2023 restrictions on mifepristone, including special certification requirements for prescribers and pharmacies, were not sufficiently justified. The decision follows a lawsuit by abortion providers in Kansas, Montana, and Virginia, who argued the restrictions were excessive and inconsistent with legal requirements.

A federal judge in Virginia ruled that the FDA's 2023 restrictions on mifepristone, a drug used to terminate early pregnancies, are unlawful due to insufficient justification. The ruling follows similar challenges from abortion providers in Kansas, Montana, and Virginia, who argued the restrictions—requiring special certifications and risk acknowledgment forms—are excessive and medically unnecessary.