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ACOG Releases Statement on FDA Announcement Regarding Changes to Restrictions on Provision of Mifepristone
Washington, D.C. – Iffath Abbasi Hoskins, MD, FACOG, president of the American College of Obstetricians and Gynecologists (ACOG), today released the following statement regarding the FDA’s announcement of changes to restrictions on the provision of mifepristone:
“Today’s announcement that the FDA will officially remove the in-person dispensing requirement for mifepristone for reproductive health indications represents an important step forward in securing access to medication abortion. ACOG has advocated for many years for the in-person dispensing requirement to be removed from the risk evaluation and mitigation strategy (REMS) for mifepristone. There is no clinical evidence that in-person dispensing improves the safety of this medication or patient outcomes; instead, this requirement unnecessarily restricted patient access to a safe and effective medication. Since 2020, continued usage of mifepristone for abortion care without the in-person dispensing requirement has been shown to be safe and effective, and the official change to the REMS means that clinicians now have concrete peace of mind that this regulation which has proven to be unnecessary has been removed.
Allowing for brick-and-mortar pharmacies to join mail-order pharmacies in dispensing mifepristone for reproductive health indications will further improve access for patients. ACOG has long advocated that mifepristone be made available in retail pharmacies, just like other prescription drugs, to allow more patients access to abortion care without clinically unnecessary hurdles. 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.
Codifying these important regulatory changes is a positive development at the end of a crushing year for abortion care. As more states ban and severely restrict abortion care following the Dobbs decision, every single effort to improve access to medication abortion matters. Although the FDA’s announcement today will not solve access issues for every person seeking abortion care, it will allow more patients who need mifepristone for medication abortion additional options to secure this vital drug.
Restricting access to mifepristone interferes with the ability of obstetrician–gynecologists and other clinicians to deliver the highest-quality evidence-based care for their patients. ACOG will continue advocating for the full removal of the REMS on mifepristone—which is consistent with the medical evidence—to allow more people the option of medical management for early pregnancy loss and abortion.”