Mifepristone REMS For Pharmacies Contains Some Unusual Provisions, Continues Debate Over Access
After FDA clears modified REMS, certified retail pharmacists are permitted to dispense the abortion medication. Some advocates argue program is unnecessary, while others want a broader federal effort to expand access. Walgreens intends to become a certified pharmacy.
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US FDA is once again considering changes to the Risk Evaluation and Mitigation Strategy for the acne medication, a year after modifications to the program caused disruptions in patient access.
The American College of Obstetricians and Gynecologists and 48 other groups request the FDA ask Danco Laboratories to file a supplemental NDA for an expanded indication and eliminate requirements for provider and pharmacist certification. For now, Danco is focused on updating the REMS as modified in December.
HHS report on protecting reproductive care shows administration is reluctant to take bold actions to counter Supreme Court’s Dobbs decision. Report does not suggest revising or eliminating mifepristone’s REMS or seeking preemption legal battles as some advocates have urged.