The changes will almost certainly widen access for patients seeking medicated abortions in states without legal obstacles.
A finalized regulatory change announced Tuesday by the FDA will allow retail pharmacies to sell abortion pills, potentially having a significant effect on patient access and pharmacists’ roles.
The regulatory change applies to mifepristone, which is the first pill used in a 2-drug medication abortion. Previously, mifepristone could only be dispensed by limited mail order pharmacies or by specialty physicians and clinics, according to The New York Times.1 Under the new rules, patients will need a prescription and dispensing pharmacies must agree to specific criteria to provide the medication.2
“In a post-Roe world, patients need all available options to get the care they need, whether in-person, by mail, or at the local pharmacy,” said Kirsten Moore, director of the Expanding Medication Abortion Access Project, in a statement. “Today’s announcement means that people who live in states that have not banned medication abortion care may soon be able to walk into their neighborhood pharmacy and walk out with their medications in hand.”3
Mifepristone blocks progesterone, which is necessary for pregnancy to continue. When used together with misoprostol, the combination treatment can end a pregnancy through 10 weeks gestation. Mifepristone was first approved in September 2000 for the medical termination of pregnancy through 7 weeks gestation, and this was extended to 10 weeks gestation in 2016.2
Under the FDA Risk Evaluation and Mitigation Strategies (REMS) program, mifepristone must be prescribed by a qualified health care provider who has completed a Prescriber Agreement Form, and the risks of mifepristone must be fully explained to the patient. The patient must also receive FDA-approved information, and mifepristone may only be dispensed by or under the supervision of a certified prescriber or certified pharmacy.2
Importantly, to become certified to dispense mifepristone, pharmacies must complete a Pharmacy Agreement Form and certified pharmacies must be able to ship mifepristone using a shipping service with tracking information. Certified pharmacies must also ensure that mifepristone is dispensed to the patient in a timely manner.2
This move is the latest in a series of recent changes and updates to the mifepristone REMS requirements. Previously, the in-person dispensing requirement was not enforced between July 2020 and January 2021, due to the COVID-19 pandemic. In 2021, after reviewing the REMS program, FDA officials determined that it must be modified to reduce the burden on the health care system and to ensure that the benefits outweigh the risks of its use.2
On December 16, 2021, the FDA announced several key modifications to the REMS program, including removing the in-person dispensing requirement and adding a requirement that pharmacies be certified to dispense the drug.2
The REMS changes are the result of nearly year-long negotiations between the FDA and the 2 companies that manufacture mifepristone, according to The New York Times. Key points in the agreements include allowing pharmacies to offer the pills and how to keep the identities of prescribing physicians confidential to protect their privacy and safety.2 The Times contacted spokespersons from several large pharmacy chains, including Walgreens, who said the company is reviewing the FDA’s decision but did not confirm whether they would choose to make the pills available.2
Legal obstacles also persist, with abortion bans or restrictions making it illegal or very challenging for pharmacies to provide the abortion pills in many states. In states where abortion remains legal, demand for the pills could be high.2
Critics of the decision and anti-abortion advocates have argued that providing the pills in pharmacies is unsafe, despite very well-established safety data. The most common adverse events (AEs) >15% are nausea, weakness, fever or chills, vomiting, headache, diarrhea, and dizziness. Serious AEs can include fatal infections or bleeding.4
Notably, mifepristone is currently only approved for abortion, although it can sometimes be used in the treatment of some miscarriages. The New York Times noted that there may be pressure to allow pharmacies to dispense it for this use as well.1
Regardless, the changes will almost certainly widen access for patients seeking medicated abortions in states without legal obstacles.
“We applaud the FDA for following the science and lifting one of the outdated and unnecessary barriers to medication abortion care,” Moore said in the statement. “By allowing brick-and-mortar pharmacies to dispense medication abortion care, the FDA is treating medication abortion like the safe, effective, time-sensitive care that it is.”3