The Food and Drug Administration recently finalized a rule change that will widen the availability of abortion pills to additional pharmacies, including mail-order companies and large chains.
The Biden administration partially enacted the change last year, announcing the long-standing requirement that women pick up the medicine in person would no longer be enforced. The action formally overhauls the drug’s labeling to allow more retail pharmacies to distribute the pills as long as they fulfill a certification process.
The change may expand access to both online pharmacies and brick-and-mortar stores. Women can get prescriptions by telehealth consultation with health professionals, then obtain pills through the mail, which is allowed by law.
Nevertheless, the change in the rule’s impact has been halted by numerous state laws that limit abortion broadly, specifically the pills. Legal experts anticipate years of court battles over medication access as proponents of abortion rights bring test cases to challenge the state’s restrictions.
For over 20 years, the Food and Drug Administration (FDA) labeling has limited dispensing to a batch of clinics and specialty offices due to safety concerns. During the coronavirus pandemic, the FDA suspended the in-person requirement temporarily. The agency said later that the new scientific review by staff at the agency supports easing access, agreeing with several medical societies that had long said the restrictions were unnecessary.
Two drugmakers that make generic and brand-name versions of abortion pills requested the latest update to FDA labeling. Agency rules require companies to file applications before dispensing drug restrictions.
Danco Laboratories, which manufactures Mifeprex, stated that the change “is critically important to expanding access to medication abortion services and will provide healthcare providers” with other options for prescribing the drug.
American College of Obstetricians and Gynecologists say update “important step”
The American College of Obstetricians and Gynecologists said the update was 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,” said the group in a statement.
Over half of the abortions performed in the United States are now done with pills instead of surgery, according to a research group that supports abortion rights, the Guttmacher Institute.
In 2000, the FDA approved mifepristone to terminate pregnancies until ten weeks, combined with a second drug, misoprostol. Mifepristone is taken to block the hormone progesterone and dilate the cervix, which is required to sustain a pregnancy. Misoprostol is taken 24 to 48 hours later, which causes the uterus to contract and expel tissue from the pregnancy.
While bleeding is a common side effect, serious complications are rare. According to the FDA, more than 3.7 million women in the U.S. have used mifepristone since it was approved.
Numerous FDA-mandated safety requirements remain in effect, including training requirements prescribers must fulfill to become certified to provide emergency care in the event of excessive bleeding. Pharmacies that dispense the pills must also acquire certification.