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FDA finalizes rule allowing sale of abortion pills by mail



(Washington) The Food and Drug Administration (FDA) on Tuesday finalized a rule change that allows women seeking abortion pills to obtain them by mail, replacing a longstanding requirement in the United States that they must pick up the drug in person.

The Biden administration implemented the change last year, announcing it would no longer enforce the distribution rule. Tuesday’s decision officially updates the drug’s labeling to allow women to obtain a prescription through a telemedicine consultation with a medical professional and then receive the pills in the mail, where permitted by law.

However, the impact of this rule change was mitigated by numerous state laws restricting abortion in general and the use of pills in particular. Legal experts predict years of court battles over access to the pills, as abortion rights activists present test cases to challenge state restrictions.

For more than 20 years, FDA labeling had restricted distribution to doctor’s 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 its staff supported the easing of access, agreeing with many medical organizations that had long said the restriction was unnecessary.

Two drugmakers that produce 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 the Mifeprex brand, 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 for prescribing the drug. drug.

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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