On Tuesday, The Food and Drug Administration finalized a rule change that broadens availability of abortion pills to retail pharmacies across the U.S.
Under the new FDA rule, pharmacies like Walgreens and CVS can apply for a certification to distribute mifepristone with the drugmakers and, if granted the certification, the pharmacy will be able to dispense the pill directly to patients upon receiving a prescription.
Mifepristone is part of the two-drug regimen that includes misoprostol. Mifepristone works by blocking the hormone progesterone, which is necessary for pregnancy development, and can be taken in the first 10 weeks of pregnancy. Misoprostol, which is taken one or two days after mifepristone, causes contractions that lead to the expulsion of pregnancy tissues.
Abortion pills, which are used in more than half of all abortions in the U.S., have reportedly become even more sought after the Supreme Court overturned Roe v. Wade in June 2022.
Tuesday’s FDA decision allows patients who obtained a prescription to turn to retail pharmacies to pick up the abortion pill in-store or by mail order, instead of referring to a limited number of specially certified doctors, clinics and pharmacies.
From Fox News:
The Food and Drug Administration on Tuesday finalized a rule change that broadens availability of abortion pills to retail pharmacies across the U.S.
The change comes as abortion pills, already used in more than half of pregnancy terminations in the US, are becoming even more sought after in the aftermath of last year’s Supreme Court decision overturn Roe vs. Wade.
Last year, the Biden administration partially implemented the change with the president announcing that pharmacies would no longer enforcement the requirement that women must pick up the medicine in person. The FDA’s action formally updates the drug’s labeling to allow the vast majority of retail pharmacies to distribute the pills.
Until now, mifepristone, the first pill used in the two-part medicated abortion process, could be dispensed only by some mail-order pharmacies or by specially certified doctors or clinics.
Under the new FDA rule, pharmacies – like Walgreens and CVS – can apply for a certification to distribute mifepristone with the drugmakers and if granted the certification, the pharmacy will be able to dispense the pill directly to patients upon receiving a prescription from a certified prescriber.
While the FDA did not issue an announcement about the decision, the two makers of the pill, Danco Laboratories and GenBioPro, released statements saying the agency had informed them of the action.
“Pharmacies who become certified in the Mifepristone REMS Program may dispense Mifeprex directly to patients upon receipt of a prescription from a certified Mifeprex prescriber, provided a Prescriber agreement is provided or on file with the certified pharmacy,” Danco Laboratories said in an online statement.
The American College of Obstetricians and Gynecologists called the update an “important step” forward.
“Although the FDA’s announcement today will not solve access issues for every person seeking abortion care, it will allow more patients who need mifepristone for medication abortion additional options to secure this vital drug,” the group said in a statement.
In 2000, the FDA approved mifepristone to terminate pregnancies of up to 10 weeks, when used with a second drug, misoprostol. Mifepristone is taken first to dilate the cervix and block the hormone progesterone, which is needed to sustain a pregnancy. Misoprostol is taken 24 to 48 hours later, causing the uterus to contract and expel the fetus.
