The FDA is now permitting mifepristone (Mifeprex), one of two drugs used for medication abortion, to be dispensed in retail pharmacies, the .
Prior to this announcement, mifepristone could only be dispensed by some mail-order pharmacies, or in person by specially certified providers. This week's decision will allow patients to pick up the abortion pill at brick-and-mortar locations, including local drugstores or chain pharmacies like CVS or Walgreens.
The decision to further relax restrictions on mifepristone was announced by the FDA in a set of Tuesday. The rule will not apply to pharmacies in the roughly that have near-total abortion bans, as well as those that restrict access to the abortion pill.
Pharmacies who want to stock and dispense mifepristone must still undergo a special certification process, and abide by a specific set of criteria, to provide the drug. However, as medication abortion , reproductive health advocates say that this decision will vastly improve access.
"This change will empower patients who choose medication abortion to have the option of going to a pharmacy for immediate care rather than waiting for a mail order if that is right for them," said Iffath Abbasi Hoskins, MD, president of the American College of Obstetricians and Gynecologists (ACOG), .
Ushma Upadhyay, PhD, MPH, of the University of California San Francisco's Advancing New Standards in Reproductive Health program, told 鶹ý that this decision was "long overdue," noting that she is disappointed that the FDA did not take this opportunity to lift more restrictions on mifepristone, including the provider and pharmacy certifications required to administer the drug, which she said are not supported by scientific evidence.
"That's my worry, that these restrictions are going to pose additional hurdles that will dissuade providers and pharmacies from providing this medication," Upadhyay added.
The FDA initially approved mifepristone for terminating pregnancies up to 7 weeks' gestation in 2000; in 2016, this was extended to 10 weeks' gestation. However, the medication was put into a , a drug safety program that the FDA requires for certain medications to ensure that the benefits outweigh the risks.
Mifepristone's REMS protocols originally included an in-person dispensing requirement, which mandated that patients receive the drug directly from a certified health provider in a medical office, clinic, or hospital. But in December 2021, the agency did away with the in-person dispensing provision, allowing for telemedicine prescription and mail delivery of the abortion pill by certain pharmacies. Prior to that decision, the FDA had decided not to enforce the in-person dispensing rule during the COVID-19 pandemic.
However, when the FDA permanently removed the in-person dispensing requirement, it added a condition mandating that pharmacies acquire a special certification to dispense the drug. The newest update provides the guidelines around how those pharmacies can get certified.
The FDA left some other requirements in place under the REMS protocol, including a rule that requires providers who want to prescribe mifepristone to complete an agreement form showing they have the knowledge and ability to administer the medication. Additionally, patients receiving the drug must also sign an agreement form.
Upadhyay noted that the necessity of the remaining REMS protocols should be investigated, including the rule that primary care providers who are not certified are not allowed to prescribe mifepristone.
"I think we need more research on these questions, and we need the FDA to allow this type of research to take place," she said.