Mifepristone REMS

(a) In general Not later than 90 days after the date of enactment of this Act, the Secretary of Health and Human Services shall— (1) withdraw approval of the risk evaluation and mitigation strategy pursuant to section 505–1 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355–1) for the covered medication that is in effect on the date of enactment of this Act; and (2) approve a risk evaluation and mitigation strategy for the covered medication that is identical to the risk evaluation and mitigation strategy for such covered medication that was approved by such Secretary in June 2011. (b) Restriction Notwithstanding any provision of section 505–1 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355–1), the Secretary of Health and Human Services— (1) shall require a risk evaluation and mitigation strategy pursuant to such section 505–1 for the covered medication; and (2) may not approve a risk evaluation and mitigation strategy pursuant to such section for the covered medication that is different from the strategy described in subsection (a)(2).