Human Rights Measure
FDA Acting Commissioner Janet Woodcock has Notified ACOG [American College of Obstetricians and Gynecologists] and SMFM [Society for Maternal-Fetal Medicine] that the Agency will “Exercise Enforcement Discretion” Regarding Mifepristone though the Duration of the COVID19 Public Health Emergency
The Center for Drug Evaluation and Research of the U.S. Food and Drug Administration (FDA) announced in a letter that it “intends to exercise enforcement discretion during the COVID-19 PHE [public health emergency] with respect to the in-person dispensing requirements of the Mifepristone REMS [Risk Evaluation and Mitigation Strategy] Program” and “to exercise enforcement discretion during the COVID-19 PHE with respect to the dispensing of mifepristone through the mail either by or under the supervision of a certified prescriber, or through mail-order pharmacy when such dispensing is done under the supervision of a certified prescriber.” The FDA’s determination was “effective immediately.” Subsequently, on December 16, 2021, the FDA announced “modifications to the Mifepristone REMS Program” consisting of the following: “[r]emoving the requirement that mifepristone be dispensed only in certain healthcare settings, specifically clinics, medical offices, and hospitals (referred to as the ‘in-person dispensing requirement’)” and “[a]dding a requirement that pharmacies that dispense the drug be certified.”
