The U.S. FDA, after a full review of the mifepristone Risk Evaluation and Mitigation Strategy program, will permanently allow patients to receive the abortion medication by mail instead of requiring them to obtain the pills in person.
Earlier this year, because of the pandemic, the agency temporarily lifted the requirement that mifepristone — the drug that blocks the hormone progesterone needed for a pregnancy to continue — be dispensed directly to the patient by certified prescribers in a clinic, medical office or hospital.
The drug was first approved by the FDA in 2000 under the brand name Mifeprex, In 2019, the agency approved
GenBioPro's generic version of the drug. The approvals came with a REMS program — to ensure the benefits of the medication outweigh its risk — that mandated in-person dispensing.
Now, FDA has announced that the REMS on Mifeprex and its generic versions must be modified by removing the in-person dispensing requirement.
According to the agency, "FDA determined that the data support modification of the REMS to reduce burden on patient access and the health care delivery system and to ensure the benefits of the product outweigh the risks." The modifications will also add a requirement that pharmacies that dispense the drug be certified.