FDA to Allow Abortion Pills at Pharmacies

Medication abortion pills can now be offered at pharmacies, where state law allows, removing the requirement that patients must receive mifepristone from a specific clinic or provider, according to new rules and updated prescription information from the US Food and Drug Administration. 

Danco Laboratories, which makes the Mifeprex brand of mifepristone, announced the changes Tuesday. GenBioPro, which makes a generic mifepristone, also confirmed the changes. 

The medication abortion regimen regulated by the FDA is for ending pregnancies through 10 weeks gestation. Medication abortions account for more than half of US abortions, and demand for the pills has grown since the US Supreme Court overturned Roe v. Wade, erasing or restricting abortion access in many states. 

Mifepristone is the first pill patients take, and it works by temporarily blocking the production of progesterone, a hormone needed to grow a pregnancy. Misoprostol, the second pill in a medication abortion, is prescribed for other uses besides abortion, including miscarriage. Of the two pills, mifepristone has been more restricted, and dispensed with specific guidelines, since its only approved use is for terminating a pregnancy. 

Though the exact effect of the FDA's finalized rules remains to be seen, it means patients seeking an abortion will be able to get medications at certified pharmacies that choose to stock the pills, in states where abortion is allowed.

What's next for pharmacies?

In order for people to get medication abortion pills at a pharmacy, they still need a prescription from a health care provider. In addition to state law, pharmacies, including those at big retailers such as CVS and Walgreens, will need to determine if they want to stock the pills. 

A spokesperson for CVS told CNET that the pharmacy is currently reviewing the FDA's guidance for mifepristone (officially called the REMS program, or Risk Evaluation and Mitigation Strategy) to "determine the requirements to dispense in states that do not restrict the dispensing of medications prescribed for elective termination of pregnancy."

A spokesperson with Walgreens said the company is also reviewing the new guidance and "will continue to enable our pharmacists to dispense medications consistent with federal and state law."

Walmart didn't immediately respond to a request for comment. 

An official with Danco Laboratories, who spoke with The New York Times on condition of anonymity, predicted that the first pharmacies to offer mifepristone might be university pharmacies or hospital pharmacies. It could take bigger chains longer because of the logistics of dispensing mifepristone.

The new guidance from the FDA also allows mifepristone to be sent to patients by mail through a certified pharmacy, and finalizes earlier pandemic-era guidance that dropped the requirement that people must pick up their medication in person. Since the overturn of Roe v. Wade, demand for abortion pills at online pharmacies outside the country has gone up, though these pills aren't regulated by the FDA.