October 29, 2018
Abortion groups want FDA to allow abortion pill use without medical supervision
The abortion pill regimen is made up of two drugs: Misoprostol and Mifeprex, which is currently regulated by the FDA under a system known as REMS, an acronym that stands for Risk Evaluation and Mitigation Strategies. The REMS document states that, “Mifeprex must be dispensed to patients only in certain healthcare settings, specifically clinics, medical offices, and hospitals, by or under the supervision of a certified prescriber.” The pill’s manufacturer, Danco Laboratories, must “[e]nsure that Mifeprex is not distributed to or dispensed through retail pharmacies or other settings….”
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