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WASHINGTON, Jan. 4 (AP) — The U.S. Food and Drug Administration finalized a rule change Tuesday that would allow women seeking abortion pills to get them by mail, replacing a longstanding requirement to pick them up in person.
The Biden administration implemented the change last year, announcing it would no longer enforce dispensing rules. Tuesday’s action formally updated the drug’s label to allow women to obtain a prescription through a telehealth consultation with a health professional and then receive the pills in the mail, as permitted by law.
Still, many state laws restrict abortion broadly and the pill specifically, but the impact of the rule change has waned. Legal experts expect a multi-year court battle over access to the pills as abortion-rights supporters present test cases to challenge state restrictions.
For more than 20 years, FDA labels have limited dispensing in doctors’ offices and clinics due to safety concerns. During the COVID-19 pandemic, the FDA has temporarily suspended in-person requirements. The agency later said a new scientific review by agency staff supported the looser access, agreeing with many medical societies that have long said the restrictions were not necessary.
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Two drugmakers that make brand-name and generic abortion pills are asking the FDA to update their labels. Agency rules require companies to submit applications before modifying drug dispensing restrictions.
Danco Laboratories, which sells the brand Mifeprex, said in a statement that the change is “critical to expanding access to medical abortion services and will give health care providers” another option for prescribing the drug.
According to the Guttmacher Institute, a pro-abortion rights research group, more than half of U.S. abortions are now performed with drugs rather than surgery.
In 2000, the FDA approved mifepristone to terminate pregnancies of up to 10 weeks when used with a second drug, misoprostol. Mifepristone is given first to dilate the cervix and block the hormone progesterone needed to maintain pregnancy. Misoprostol is given 24 to 48 hours later to make the uterus contract and expel the pregnancy tissue.
Bleeding is a common side effect, but serious complications are very rare. Since its approval, more than 3.7 million American women have used mifepristone, the FDA said.
Some FDA-mandated safety requirements remain in effect, including training requirements to demonstrate that prescribers can provide emergency care in the event of excessive blood loss. Pharmacies that dispense prescriptions also require certification. (Associated Press)
(This is an unedited and auto-generated story from a Syndicated News feed, the content body may not have been modified or edited by LatestLY staff)
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