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March 29, 2016executiveFDA drug regulationREMSmedication abortionreproductive rightspharmaceutical regulationreproductive healthFDA rulemaking

FDA extends mifepristone use to 70 days and expands prescriber eligibility

The FDA approves a notable update to the mifepristone REMS, extending approved use from 49 days to 70 days gestation, expanding the universe of eligible prescribers beyond physicians to include nurse practitioners, physician assistants, and certified nurse midwives, and reducing the required number of in-person dispensing visits from three to one. The update comes after 16 years of accumulated safety data showing the original restrictions were more stringent than necessary. Abortion rights advocates argue the changes still leave the in-person dispensing requirement in place unnecessarily. The update triples the window for medication abortion access and significantly expands provider capacity, increasing the number of facilities where patients can obtain the drug.