FDA Permits Retail Pharmacies To Distribute Abortion Pills, Ups Access After SCOTUS 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.
- A spokesperson for CVS Health Corp and Walgreens Boots Alliance Inc said they were reviewing the updated REMS "drug safety program certification requirements for mifepristone to determine the requirements.
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