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Wednesday, January 4, 2023

FDA expands availability of abortion-inducing medication

Women who want to use a pill to end their pregnancy in the first 10 weeks will now be able to get it directly from health-care providers and pharmacies. The move by the U.S. Food and Drug Administration expands options for women in Kentucky, where almost all abortions are currently illegal. The state Supreme Court, in a pending case, could change that.

The FDA announced the new rules for the abortion-inducing drug mifepristone Tuesday night. The drug is already used in more than half of the abortions in the United States.

"Prior to this announcement, mifepristone could only be dispensed by some mail-order pharmacies, or in person by specially certified providers," MedPage Today notes. "This week's decision will allow patients to pick up the abortion pill at brick-and-mortar locations, including local drugstores or chain pharmacies like CVS or Walgreens." Those chains said they would sell the drug. Rite Aid said it was reviewing the FDA's action, USA Today reports.

Last year, the FDA allowed the drug to be obtained by mail, but the Kentucky General Assembly banned that in a wide-ranging anti-abortion bill. FDA proposed the changes in December 2021, "six months before the Supreme Court overturned Roe v. Wade and left abortion policy up to individual states," notes Beth Wang of Inside Health Policy. In Kentucky, the decision activated a "trigger law" that bans abortion except to save the woman's life.

The changes announced Tuesday allow pharmacies that go through a certification process, still not specified, to dispense the drug directly to patients who have a prescription from a certified prescriber who has an agreement with the certified pharmacy, Wang reports.

UPDATE, Jan. 5: "Legal scholars slammed FDA’s certification requirements for pharmacies to dispense the abortion pill, mifepristone, saying they’re unnecessary and not based in science, and the experts called on FDA to get rid of the prescribing and dispensing restrictions altogether," Wang reports.

"FDA also has permanently removed the requirement that patients see a health-care provider in person before being prescribed the drug," Wang notes. "That requirement was temporarily removed during the Covid-19 public health emergency." However, Kentucky law bans the use of telemedicine to get a mifepristone prescription.

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