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FDA to Allow Retail Pharmacies to Offer Abortion Pills

January 4, 2023 by Dan McCue
(Allen G. Breed/Associated Press)

WASHINGTON — An abortion pill previously available only from a certified doctor, clinic or two online pharmacies will soon be obtainable at local pharmacies with a prescription, the Food and Drug Administration announced Tuesday.

Mifepristone is the first of two drugs in medication abortions.

The change in FDA regulations comes as abortion pills, already used in more than half of pregnancy terminations in the U.S., are becoming even more sought after in the aftermath of last year’s Supreme Court decision in Dobbs v. Jackson Women’s Health Organization, overturning the federal right to abortion. 

The Biden administration partially implemented the change last year, announcing it would no longer enforce a long-standing requirement that women pick up the medicine in person. 

Tuesday’s action formally updates the drug’s labeling to allow many more retail pharmacies to dispense the pills, so long as they complete a certification process.

Still, the rule change’s impact has been blunted by numerous state laws limiting abortion broadly and the pills specifically.

Danco Laboratories, which sells branded Mifeprex®, said in a statement the change “is critically important to expanding access to medication abortion services and will provide health care providers” with another option for prescribing the drug.

GenBioPro, another firm that produces the pill, published a statement on its website that merely said it had been informed of the action.

Elsewhere on its website, the pharma company said, “We believe that access to reproductive health care is a fundamental human right. We are dedicated to decreasing barriers, increasing access, and advocating for providers and patients alike.”

The FDA did not post a formal announcement of the regulatory change on its website. However, it updated its page on mifepristone and published a series of questions and answers about the use of the drug.

Mifepristone blocks progesterone, a naturally produced hormone that prepares the lining of the uterus for a fertilized egg and helps maintain pregnancy. 

Without progesterone the pregnancy cannot continue and the lining of the uterus softens, breaks down and bleeding begins. 

Mifepristone is used in a regimen with a prostaglandin, misoprostol, which causes the uterus to contract and helps complete the process.

Dan can be reached at dan@thewellnews.com and at https://twitter.com/DanMcCue

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