The new year has just begun and the Food & Drug Administration (FDA) has wasted no time implementing the revised label for the distribution of the abortion pill Mifeprex®/mifepristone through participating pharmacies. Once again, they are removing more safety measures from the REMS requirements.
REMS stands for Risk Evaluation and Mitigation Strategy and is a special FDA program reserved for drugs where the risks may outweigh the benefits unless certain measures are put in place. Of the ~19,000 drugs currently FDA-approved, only 60 require a REMS label. Mifepristone is one of them.
Originally, the REMS requirements for Mifeprex included:
The in-person visit was a critical part of the FDA's REMS program for Mifeprex. Without an in-person visit, how would pregnancy be confirmed and accurate pregnancy dating take place? How would a miscarriage, or an ectopic pregnancy, or twins be identified? Without this vital information, women’s lives will be put at risk.
The pandemic provided the perfect "storm" that opened the door to telemed abortions. During the pandemic, abortion advocates sued the FDA demanding that the in-person restriction be temporarily lifted so women could have access to abortion during the COVID lockdowns. The FDA caved and granted the temporary removal of the in-person requirement.
In December 2021, after an evaluation of limited data, the FDA determined that it was “safe” to remove the in-person requirement permanently. This has resulted in an explosion of telemedicine abortion clinics.
With a telemed abortion, there is no direct hand-off of the pills between provider and patient. The FDA added a provision for pharmacies to apply and register with the pharmaceutical company manufacturing mifepristone (Danco Labs, make Mifeprex® (brand name); GenBioPro, make generic mifepristone).
As of January 3, 2023, the FDA is implementing the revised REMS requirements, allowing pharmacies to participate in the distribution of abortion pills with the following stipulations:
What it means:
Walgreens, CVS, and Rite Aid have stated they will apply to be a certified dispensing pharmacy for mifepristone / Mifeprex, but only in states that allow abortion.
The in-person visit was a critical feature of the REMS requirements to reduce the risks and serious complications associated with the use of mifepristone/misoprostol for induced abortion. Now the door is open to pharmacy distribution. Expect to see conscientious objections from individual pharmacists who will choose not to participate in handing out abortive drugs.
The removal of safety measures from an already potentially hazardous drug protocol is a disservice to women and represents a step backwards in women’s healthcare. If the FDA removes all REMS requirements from mifepristone, little stands in the way of it eventually becoming an over-the-counter drug.