The FDA has changed its policy on the medication abortion pill mifepristone, allowing it to be sold through retail pharmacies.
Pharmacies, which will be required to be certified to carry mifepristone, will be able to send the pills by mail; previously, patients were required to pick them up in person.
While this policy change is seen as a step in the right direction by abortion advocates, challenges to providing mifepristone remain. Medication abortion remains illegal in some states, and some pharmacies may decide against providing the drug to customers.
The FDA has updated its labeling of mifepristone—the pill that ends an intrauterine pregnancy at up to 10 weeks of gestation—expanding its availability through retail pharmacies and via mail order.
On January 3, 2023, the FDA announced it had modified its mifepristone risk evaluation and mitigation strategy (REMS) program to allow the pill to be distributed through brick-and-mortar and online pharmacies after they meet certain qualifications and are certified under the program.
Previously, the pills were only dispensed through specialty offices and clinics, and women were required to pick them up in person. According to an AP News report, the in-person rule was temporarily suspended during the height of the COVID-19 pandemic and is now permanently lifted, allowing the pills to be distributed by mail where permitted by law.
Changes to program explained
This change is seen as a move to expand access to abortion by the Biden administration in its effort to protect abortion rights following the US Supreme Court’s overturning of Roe v Wade in 2022, according to an article published by Reuters.
Revisions to the REMS policy detailed in the FDA announcement include the following:
In addition to being certified to distribute mifepristone, pharmacies must complete a Pharmacy Agreement Form.
If shipping the drug, they must use a service that provides tracking information.
Patients will be required to sign a Prescriber Agreement Form filled out by the pharmacy and must receive the FDA-approved Mifepristone Medication Guide before receiving their prescription.
In 2018, the FDA reported that more than 3.7 million in the US had used mifepristone since it was approved in 2000. Mifepristone dilates the cervix and blocks the hormone progesterone, which is needed for a pregnancy to continue. The drug is available as a generic prescription and under the brand name Mifeprex.
‘Game-changer’ provokes controversy
This policy change was viewed as a step in the right direction by abortion rights advocates.
Planned Parenthood president Alexis McGill Johnson called it “a positive step forward and a win for health equity” on Twitter.
"Picking up your prescribed medication abortion from a pharmacy will be a game changer for people accessing time sensitive care."
— Alexis McGill Johnson, Planned Parenthood
Iffath Abbasi Hoskins, MD, FACOG, president of the American College of Obstetricians and Gynecologists, called the removal of in-person dispensing requirements “an important step forward in securing access to medication abortion” adding that the organization had advocated for the removal of this rule for “many years.”
However, GenBioPro, manufacturer of generic mifepristone, said in a statement that this change will not provide equal access to all people, due to legislation in more than a dozen states banning abortion, including (in some states) medication abortion such as mifepristone.
Even with the revised rules, women in states where the pills are banned may have to travel to states where medication abortion is legal to receive their prescriptions.
Pharmacies must decide
It will be up to pharmacies to determine if they want to provide mifepristone to patients, given the controversy over the abortion issue.
According to Reuters, CVS Health is reviewing the revised REMS before deciding if it will dispense the pill in its stores.
Walgreens told the news service that it “will continue to enable our pharmacists to dispense medications consistent with federal and state law.”
What this means for you
The easing of regulations on the distribution of mifepristone is expected to change the landscape for providing medication abortion to patients. In states where it is legal, the revised FDA rules should make it easier for your patients to obtain the pills. But this change could create new challenges, including the possibility that some pharmacies may not participate in the revised program, and considerations of whether to send patients to a state where mifepristone is provided legally to get their pills. Physicians should stay current on this hot-button issue.