A group of 25 House Republicans led by Rep. Buddy Carter (GA) want FDA to reverse its recent decision to loosen some of the prescribing and dispensing restrictions on the abortion pill mifepristone, arguing in a Wednesday (Jan. 11) letter to FDA chief Robert Califf that the drug poses significant health risks for pregnant people and that it’s not in the best interest of patients to allow pharmacies to dispense the pill.
The pushback comes as House lawmakers pass abortion-related provisions -- the Born Alive Abortion Survivors Protection Act (H.R. 26), which would ensure infants born alive after an abortion receive legal and medical protection, and a resolution condemning recent attacks on pro-life facilities, groups and churches. Mifepristone, sold under the brand name Mifeprex, is FDA-approved for abortion up to 10 weeks of pregnancy. It’s taken in combination with misoprostol to induce early abortions or to treat early miscarriages. Mifepristone is subject to certain prescribing and dispensing restrictions under a risk evaluation and mitigation strategy (REMS); misoprostol is not.
FDA on Jan. 3 finalized changes to the prescribing and dispensing restrictions for mifepristone, allowing licensed health care providers and certified pharmacies, including retail pharmacies, to dispense the drug. FDA also permanently removed the requirement that patients see a health care provider in person before being prescribed the drug, which allows patients to get a prescription via telehealth and have it delivered through the mail.
FDA first proposed the changes in December 2021, six months before the Supreme Court overturned Roe v. Wade and left abortion policy up to individual states. Women’s health advocates said loosening at least some of the prescribing restrictions on mifepristone would allow for the drug to be accessed remotely and possibly even help preserve some access to medication abortion care as an increasing number of states ramp up abortion restrictions.
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