December 16, 2021executiveFDA drug regulationREMS modificationmedication abortionreproductive rightspharmaceutical regulationreproductive healthFDA rulemaking
Biden FDA permanently removes in-person dispensing requirement from mifepristone REMS
The FDA permanently modifies the mifepristone REMS to eliminate the in-person dispensing requirement, allowing certified pharmacies — including mail-order pharmacies — to dispense the drug with a valid prescription. The formal REMS update means mifepristone can now be prescribed via telemedicine and sent by mail without a clinic visit. Anti-abortion attorneys immediately begin preparing litigation challenging the modification. The change expands access dramatically: telehealth abortion services launch nationally, and by 2023 medication abortion accounts for more than 60 percent of all U.S. abortions. The REMS modification becomes the central target of the federal court challenges that culminate in the Fifth Circuit''s 2026 ruling.