Breaking News: FDA (again) Lifts Unnecessary Restrictions on Mifepristone during the Pandemic!


On April 12th, the FDA submitted a letter to the American College of Obstetricians and Gynecologists (ACOG) stating that the FDA has suspended restrictions on mifepristone that require patients to come to the clinic in person to receive the medication for the duration of the COVID-19 public health emergency. Mifepristone, which is one of the medications used in a medication abortion and to treat early pregnancy loss, has been subject to medically-unnecessary FDA restrictions (known as REMS) since it was approved in 2000. The FDA’s letter means that patients can now receive mifepristone by mail throughout the pandemic so they do not have to risk unnecessary COVID-19 virus exposure as a condition for accessing care. 


Back in May 2020, the ACLU and plaintiffs filed a lawsuit against the FDA, challenging the REMS restrictions on mifepristone during the COVID-19 pandemic. They were ultimately successful, and restrictions were lifted, allowing patients to receive their medication by mail. However, in January 2021, the Supreme Court granted the Trump Administration’s request to reinstate the REMS, despite the ongoing pandemic. 


While the FDA’s decision this time around will immediately provide easier access to abortion care and medication management of miscarriage, we still have a ways to go to remove all medically-unnecessary restrictions on mifepristone. Nineteen states still prohibit using telehealth for medication abortion, preventing folks in those states from benefitting from the FDA’s decision. The harm of these in-person regulations has fallen hardest on Black, Indigenous, and People of Color, people who live in rural areas, and those working to make ends meet. These are also the communities that have been most impacted by the COVID-19 pandemic and harmful abortion restrictions more broadly. 


We applaud the tireless, persistent efforts of reproductive health, rights, and justice organizations, advocates, and researchers that have organized, litigated, and provided critical data to enable the FDA to make this decision based in evidence and science. The Reproductive Health Access Project has long advocated for expanding access to mifepristone. Suspending these politically-motivated, unnecessary regulations on mifepristone is an important step to ensure abortion and EPL care is accessible to everyone who needs it. We urge the Biden-Harris Administration to continue dismantling policies that restrict abortion access, including permanently lifting mifepristone from REMS regulation even after the public health emergency, repealing the Hyde Amendment, and other asks of the Blueprint for Sexual and Reproductive Health, Rights, and Justice

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