The US Food and Drug Administration (FDA) on Tuesday finalized changes to dispensing requirements for mifepristone, aka the "abortion pill," that will allow certified pharmacies, including retail pharmacies, to provide the agent.
Specifically, FDA removed the requirement from the drug's risk evaluation and mitigation strategy (REMS) that mifepristone be dispensed to a patient in-person, limiting dispensing of the drug to specialty clinics, medical offices, and hospitals.
The information was provided in updates made to postmarket drug safety information on the FDA's website.
The antiprogestational steroid mifepristone, when used together with prostaglandin analogue misoprostol can end a pregnancy through 10 weeks gestation. Mifepristone was first approved in September 2000 for the medical termination of pregnancy through 7 weeks gestation, followed in 2016 by an extension of that period to 10 weeks.
As a precautionary measure, the FDA had temporarily lifted the in-person dispensing requirement during the height of the COVID-19 pandemic (July 2020 to January 2021) and mifepristone was provided through mail order pharmacies. When FDA officials reviewed the REMS program again in 2021, they determined that "available data and information support modification of the REMS to reduce burden on the health care delivery system and to ensure the benefits of the product outweigh the risks."
On December 16, 2021, the FDA announced several key modifications to the REMS program, including removing the in-person dispensing requirement and adding a requirement that pharmacies be certified to dispense the drug.
Under the new rules, patients will need a prescription and dispensing pharmacies must agree to specific criteria to provide the medication. Pharmacy certification requirements under the amended mifepristone REMS include designating an authorized representative to conduct the certification process and oversee implementation and compliance with the REMS Program on behalf of the pharmacy. Certified pharmacies also must be able to ship mifepristone using a shipping service with tracking information and ensure that mifepristone is dispensed to the patient in a timely manner.2
The American College of Obstetricians and Gynecologists (ACOG) has advocated for many years for removal of the restrictive in-person dispensing requirement saying in a statement released Tuesday that there is no evidence to support the idea that the requirement improves the medication's safety or patient outcomes. ACOG points to the safe and effective use of the product since July 2020 when mail-order delivery was required.
“Allowing for brick-and-mortar pharmacies to join mail-order pharmacies in dispensing mifepristone for reproductive health indications will further improve access for patients. ACOG has long advocated that mifepristone be made available in retail pharmacies, just like other prescription drugs, to allow more patients access to abortion care without clinically unnecessary hurdles. This change will empower patients who choose medication abortion to have the option of going to a pharmacy for immediate care rather than waiting for a mail order if that is right for them.”
ACOG also said that any restriction on access to the medication "interferes with the ability of obstetrician–gynecologists and other clinicians to deliver the highest-quality evidence-based care for their patients." The statement also notes that the College will continue to urge the removal of the risk evaluation and mitigation strategy for mifepristone, stating that would be consistent with the clinical evidence.