The Food and Drug Administration on Tuesday finalized a rule change that expands the availability of abortion pills to more pharmacies, including large chains and mail-order companies.
The Biden administration partially implemented the change last year, announcing it would not implement a longstanding requirement that women take the drug. Tuesday’s action officially updated the drug’s label to allow more retail pharmacies to dispense the pill, as long as it completes the certification process.
These changes could expand access to brick-and-mortar stores and online pharmacies. Women can get a prescription through a telehealth consultation with a health professional, and then receive pills by mail, where allowed by law.
Still, the impact of the rule change has been blunted by many state laws that restrict abortion broadly and the pill specifically. Legal experts predict years of court battles over access to the pill, as abortion rights advocates bring trial cases to challenge state bans.
For more than 20 years, the FDA label has restricted dispensing to a subset of specialty offices and clinics, due to safety concerns. During the COVID-19 pandemic, the FDA is temporarily suspending personal requirements. The agency later said a new scientific review by agency staff supports easy access, along with many in the medical community who have long said the ban is unnecessary.
Two drugmakers that make both brand-name and generic versions of abortion pills are asking for the latest FDA label updates. Agency rules require companies to file an application before changing drug dispensing restrictions.
Danco Laboratories, which sells the brand name Mifeprex, said the change was “critical to expanding access to medication abortion services and will provide healthcare providers” with more options for prescribing the drug.
The American College of Obstetricians and Gynecologists called the update an “important step” forward.
“Although the FDA’s announcement today will not solve the problem of access for everyone seeking abortion care, it will allow more patients who need mifepristone for abortion medication an additional option to secure this important drug,” the group said in a statement.
More than half of U.S. abortions are now performed with the pill rather than surgery, according to the Guttmacher Institute, a research group that supports abortion rights.
The FDA in 2000 approved mifepristone to terminate pregnancies up to 10 weeks, when used with another drug, misoprostol. Mifepristone is taken first to dilate the cervix and block the hormone progesterone, which is needed to maintain pregnancy. Misoprostol is taken 24 to 48 hours later, causing the uterus to contract and expel the pregnancy tissue.
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 it was approved.
Some FDA-mandated safety requirements remain in place, including training requirements to prove that prescribers can provide emergency care in the event of excessive bleeding. Pharmacies that dispense pills also need certification.
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The Department of Health and Science of the Associated Press receives support from the Howard Hughes Medical Institute’s Science and Education Media Group. AP is solely responsible for all content.
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