US FDA allows sale of abortion pills at pharmacies for first time

The US Food and Drug Administration (FDA) will allow retail pharmacies to offer abortion pills in the United States for the first time, the agency has said, even as more states seek to ban medication abortion.

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

The regulatory change will potentially expand abortion access as President Joe Biden’s administration wrestles with how best to protect abortion rights after they were sharply curtailed last year by the Supreme Court’s decision to overturn the landmark Roe v Wade ruling and the state bans that followed.

The agency finalised the changes after reviewing supplemental applications from Danco Laboratories and GenBioPro, the two companies that make the drug in the US.

Pharmacies can start applying for certification to distribute the abortion pill Mifepristone with one of the two companies that make it, and if successful they will be able to dispense it directly to patients upon receiving a prescription from a certified prescriber.

The FDA had first said it would be making those changes in December 2021 when it announced it would relax some risk evaluation and mitigation strategies, or REMS, on the pill, that had been in place since the agency approved it in 2000 and were lifted temporarily in 2021 due to the COVID-19 pandemic.

Agencies