FDA finalizes rule expanding availability of abortion pills : NPR


Boxes of mifepristone sit on a shelf at the West Alabama Women’s Center in Tuscaloosa, Alabama on March 16, 2022.

Allen G. Breed/AP


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Allen G. Breed/AP

FDA finalizes rule expanding availability of abortion pills : NPR

Boxes of mifepristone sit on a shelf at the West Alabama Women’s Center in Tuscaloosa, Alabama on March 16, 2022.

Allen G. Breed/AP

WASHINGTON — The Food and Drug Administration on Tuesday finalized a rule change that expands the availability of abortion pills to many more pharmacies, including large chains and mail-order companies.

The Biden administration partially implemented the change last year, announcing it would no longer enforce a longstanding requirement that women pick up the drug in person. Tuesday’s action officially updates the drug’s labeling to allow many more retail pharmacies to distribute the pills, provided they complete a certification process.

The change could expand access to physical stores and online pharmacies. Women can get a prescription through a telehealth consultation with a healthcare professional and then receive the pills in the mail, where permitted by law.

Still, the impact of the rule change was blunted by numerous state laws restricting abortion broadly and pills specifically. Legal experts predict years of court battles over access to the pills, as abortion-rights advocates present test cases to challenge state restrictions.

For more than 20 years, FDA labeling had limited distribution to a subset of specialty offices and clinics, due to safety concerns. During the COVID-19 pandemic, the FDA temporarily suspended the in-person requirement. The agency later said new scientific review by agency staff supported the easing of access, agreeing with many medical societies that had long said the restriction was unnecessary.

Two drugmakers who make branded and generic versions of abortion pills have requested the latest label update from the FDA. Agency rules require a company to file an application before changing drug dispensing restrictions.

Danco Laboratories, which sells branded Mifeprex, said in a statement that the change “is critically important to expanding access to medical abortion services and will provide healthcare providers” with another option to prescribe. medication.

The American College of Obstetricians and Gynecologists called the update a “significant step” forward.

“While today’s FDA announcement will not solve access issues for every person seeking abortion care, it will allow more patients who need mifepristone for medical abortion additional options. to secure this lifesaving drug,” the group said in a statement.

More than half of abortions in the United States are now performed with pills rather than surgery, according to the Guttmacher Institute, a research group that supports abortion rights.

The FDA in 2000 approved mifepristone for terminating pregnancies up to 10 weeks, when used with a second drug, misoprostol. Mifepristone is taken primarily to dilate the cervix and block the hormone progesterone, which is needed to maintain a pregnancy. Misoprostol is taken 24 to 48 hours later, causing the uterus to contract and push out pregnancy tissue.

Bleeding is a common side effect, although serious complications are very rare. The FDA says more than 3.7 million American women have used mifepristone since its approval.

Several FDA-mandated safety requirements remain in effect, including training requirements to certify that prescribers can provide emergency care for excessive bleeding. Pharmacies that dispense the pills also need certification.


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