FDA expands availability of abortion pills
WASHINGTON — The Food and Drug Administration on Tuesday finalized a rule change that expands supply capacity abortion pill to more pharmacies, including major chains and mail-order companies.
The Biden administration made part of this change last year, announcing that it would no longer enforce the longstanding requirement that women come in to pick up the drugs in person. Tuesday’s action officially updates drug labeling to allow more retail pharmacies to dispense the drug, as long as they complete the certification process.
This change could expand accessibility in both brick-and-mortar stores and online pharmacies. Women can receive prescriptions through a telehealth consultation with a medical professional, and then receive the medication in the mail, if permitted by law.
However, the impact of the rule change has been mitigated by numerous state laws that restrict abortion in general and the birth control pill in particular. Legal experts foresaw years of fighting in court over access to birth control pills, as abortion rights advocates brought up test cases to challenge state restrictions.
For more than 20 years, FDA labeling restricted distribution to a small group of clinics and specialty clinics due to safety concerns. During the COVID-19 pandemic, the FDA has temporarily suspended the in-person request. The agency later said a new scientific review of agency staff had supported loosening access, concurring with many medical associations that have long said restrictions were unnecessary.
Read more: Inside the push to promote abortion pills for a post-Roe America
Two drug manufacturers that produce branded and generic versions of the abortion pill have requested the latest FDA label updates. Agency rules require a company to file an application before amending drug dispensing restrictions.
Danco Laboratories, which sells the Mifeprex brand, said in a statement that the change is “extremely important for expanding access to drug abortion services and will be available to service providers.” health care” another option for prescribing.
The American College of Obstetricians and Gynecologists calls the update an “important step” forward.
“While today’s FDA announcement will not solve access issues for everyone wanting abortion care, it will allow more options for many patients who need mifepristone for a medical abortion. to secure this important drug,” the group said in a statement.
According to the Guttmacher Institute, a research group that advocates for abortion rights, more than half of all abortions in the US are now performed with medication instead of surgery.
The FDA in 2000 approved mifepristone to terminate pregnancies up to 10 weeks, when used with a second drug, misoprostol. Mifepristone is used first to dilate the cervix and block the hormone progesterone, which is needed to maintain a pregnancy. Misoprostol is taken after 24 to 48 hours, causing the uterus to contract and push the fetal tissue out.
Bleeding is a common side effect, although serious complications are rare. The FDA says more than 3.7 million US women have used mifepristone since its approval.
Some FDA-mandated safety requirements remain in effect, including training requirements to certify that prescribers can provide emergency care in the event of excessive bleeding. Pharmacies that dispense drugs also need to be certified.
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