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.
What is REMS?
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.
REMS and Mifepristone
Originally, the REMS requirements for Mifeprex included:
- In 2000, mifepristone was approved by the FDA to induce abortion up to 49 days, or 7 weeks from a woman’s last menstrual period.
- Only physicians/clinics registered with Danco Labs were authorized to dispense
- In-person visit required
- Patient must receive full explanation of risks
- Patient must sign Patient Agreement Form and receive a copy of the Medication Guide
- Three visits were required:
- During the first visit, after completion of a medical intake and confirmation of pregnancy, the woman was given the mifepristone pills to swallow in the presence of the abortion provider.
- She returned two days later to be evaluated for complications and to be given the second drug, misoprostol.
- She was instructed to return two weeks after the first visit to be evaluated for completion of the procedure.
- In 2016, the FDA expanded the gestational age to 70 days or 10 weeks LMP and removed the three visit requirement, making only one visit mandatory.
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.
What changed in January 2023?
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:
- pharmacies must complete the certification process and complete the Pharmacy Agreement Form
- must verify that the prescribing provider is certified to dispense Mifeprex®, have a copy of the Prescriber Agreement Form on file
- must receive a prescription from a certified provider who is registered with Danco Labs
- must dispense Rx within 4 days of receipt of the prescription, unless otherwise authorized by the provider
- must report any patient deaths to Danco Labs
What it means:
- The FDA REMS provision still requires healthcare professionals to formally apply and register with Danco Labs/GenBioPro as an official provider of mifepristone and are required to adhere to the remainder of the REMS requirements.
- Physicians (and other authorized healthcare professionals, such as nurse practitioners) who are registered providers of mifepristone may write prescriptions, but only to registered pharmacies.
- Pharmacies who have registered to dispense mifepristone may ONLY do so upon receipt of a valid prescription from a healthcare provider who is registered to dispense these drugs.
- Pharmacists are NOT permitted to independently dispense Mifeprex®/mifepristone apart from these requirements.
- The FDA's action doesn't take precedence over individual state laws. If an individual state does not allow elective abortions, then the abortion pills would not be distributed through pharmacies in that state.
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.