Food and Drug Administration finalizes rule change which follows US supreme court decision to end federal right to abortion
The US Food and Drug Administration (FDA) on Tuesday finalized a rule change that broadens availability of abortion pills to many more pharmacies including large chains and mail-order companies.
The Biden administration partially implemented the change last year, announcing it would no longer enforce a requirement that women pick up the medicine in person.
The new action formally updates drug labeling to allow many more retail pharmacies to dispense the pills, so long as they complete a certification process.
The change could expand access at brick-and-mortar stores and online pharmacies. Where permitted by law, women can get a prescription via telehealth consultation with a health professional then receive the pills through the mail.
The rule change comes after the conservative-dominated supreme court removed the right to abortion in a ruling last June.
The change has, however, been blunted by state laws limiting abortion broadly and pills specifically. Legal experts foresee years of court battles over access to the pills, as abortion-rights proponents bring test cases to challenge state restrictions.
For more than 20 years, FDA labeling limited dispensing to a subset of specialty offices and clinics, due to safety concerns. During the Covid-19 pandemic, the FDA temporarily suspended the in-person requirement. The agency then said a scientific review supported easing access, concurring with medical societies that said the restriction was not necessary.
Two drugmakers that make brand-name and generic versions of abortion pills requested the latest FDA label update. Agency rules require a company to file an application before modifying dispensing restrictions on drugs.
Danco Laboratories, which sells branded Mifeprex, said the change “is critically important to expanding access to medication abortion services and will provide healthcare providers” with another option 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 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,” the group said.
More than half of US abortions are now done with pills rather than surgery, according to the Guttmacher Institute, a research group that supports abortion rights.
The FDA in 2000 approved mifepristone to terminate pregnancies of up to 10 weeks, when used with a second drug, misoprostol. Mifepristone is taken first to dilate the cervix and block the hormone progesterone, which is needed to sustain a pregnancy. Misoprostol is taken 24 to 48 hours later, causing the uterus to contract and expel pregnancy tissue.
Bleeding is a common side-effect but serious complications are very rare. The FDA says more than 3.7 million US 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 in the case of excessive bleeding. Pharmacies that dispense the pills also need a certification.
