Abortion Pill Mifepristone Will No Longer Require In-Person Pick Up, US FDA Concludes
REMS modification implemented for the duration of the pandemic will become permanent, the agency determines in response to lawsuit. FDA adds a requirement that pharmacies dispensing the drug be certified.
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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.
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.
The US Supreme Court has overturned Roe v. Wade, but numerous avenues could help to preserve access to abortion drug mifepristone – if legislators and lawmakers are willing to walk down them.