Retail pharmacies in the United States can now dispense the abortion drug mifepristone for the first time, thanks to new regulatory changes by the Biden administration.
Patients now obtain mifepristone, a safe and effective dual therapy for inducing abortion, directly from their healthcare provider.
The new rule still requires a prescription, but patients can now pick up the pills over the counter or by mail.
This measure could significantly expand access to medical abortion.
Demand for abortion pills is soaring after last year’s Supreme Court ruling abolishing federal abortion rights, some states have banned or severely restricted abortion.
Already, more than half of all abortions in the United States are done with pills instead of surgery, according to the abortion advocate Gutmacher Institute.
In December 2021, the U.S. Food and Drug Administration (FDA) said it would permanently remove the requirement for patients to obtain prescriptions directly from a healthcare provider as part of a move toward telemedicine.
On Tuesday, the FDA updated its website with new requirements, saying the drug “may be dispensed by a licensed pharmacy or under the supervision of a licensed prescriber.”
Danco Laboratories and GenBioPro in the United States, which manufacture the drug, confirmed in separate statements that the agency had informed them of the decision.
The American College of Obstetricians and Gynecologists called the move “an important step.”
“Today’s announcement by the FDA will not solve the problem of access to abortion care for all, but it will help more patients who need mifepristone for medical abortion to take this important drug. We will be able to have new options to acquire,” the group said in a statement.
Mifepristone is taken with a second drug called misoprostol. Misoprostol is usually taken between the 10th and 12th week of pregnancy to induce what is known as a medical abortion. Misoprostol, which is commonly used to manage miscarriage, is not a controlled substance and is readily available at pharmacies with a prescription.
Pharmacies, from major chains to local pharmacies, can now apply for accreditation to dispense mifepristone, allowing them to serve customers directly with a prescription from an accredited prescriber. Pharmacy chains CVS and Walgreens say they are studying the new requirements.
But political landmines around abortion are likely to affect whether and where pharmacies offer the pill.