FDA Permits Retail Pharmacies To Distribute Abortion Pills, Expanding Access After Supreme Court Ruling

  • The FDA will allow pharmacies to offer abortion pills, mifepristone, in the U.S. Pharmacies must complete a form for certification to distribute the abortion pills.

  • "Under the Mifepristone REMS Program, as modified, Mifeprex and its approved generic can be dispensed by certified pharmacies or by or under the supervision of a certified prescriber," the agency said.

  • If successful, the pharmacies can dispense it directly to patients upon receiving a prescription from a certified prescriber.

  • Mifeprex was approved in 2000 with restrictions to assure its safe use. Mifeprex was deemed to have, in effect, an approved REMS under the FDA Amendments Act of 2007.

  • In 2019, when FDA approved the generic version of Mifeprex, the agency approved a single, shared system REMS for mifepristone products (known as the Mifepristone REMS Program).

  • Under the Mifepristone REMS Program, mifepristone may be dispensed in person or by mail.

  • Reuters reported that the regulatory change would potentially expand abortion access after they were sharply curtailed by the Supreme Court's decision to overturn the landmark Roe v Wade ruling.

  • Soon after the ruling, major pharmacies put a limit on purchases or deliveries of Plan B and other emergency contraceptive pills.

  • "Today's news is a step in the right direction for health equity," Planned Parenthood President Alexis McGill Johnson said in a statement.

  • A spokesperson for CVS Health Corp (NYSE: CVS) and Walgreens Boots Alliance Inc (NASDAQ: WBA) said they were reviewing the updated REMS "drug safety program certification requirements for mifepristone to determine the requirements.

  • Photo via Wikimedia Commons

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