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Published: January 5, 2022

FDA Repeals Mifepristone Dispensing Restriction

by Shannon Connolly, MD, CAFP President

The patient I didn’t get to take care of is a 15-year-old kid from Barstow, California. This sneaker-clad teen with an unintended pregnancy would have come to my clinic to receive a medication abortion, except she could not figure out the logistics of traveling 117 miles so she could pick up the medication in person from a clinic that accepts Medi-Cal.  And because I had no way of getting the medication to her, she never became my patient and I do not know what happened to her.

This past December, the US Food and Drug Administration (FDA) announced the permanent repeal of an in person dispensing requirement for the abortion drug, mifepristone.  In the past, the FDA required that mifepristone be dispensed to patients in person at a specially certified hospital, clinic, or medical office. But many health care providers are unable to stock, dispense, and bill for this medication onsite at their health center, which significantly reduced where mifepristone was available, and patients could not receive the medication by mail, delivery, or at their local pharmacy. The in person dispensing requirement was the barrier that my would-be patient from Barstow couldn’t overcome. She is one of millions in America who live further than 100 miles from the nearest clinic that provides abortion.

The FDA’s decision to repeal the in-person dispensing restriction is in response to a lawsuit filed in 2017 by the American Civil Liberties Union (ACLU) on behalf of the CAFP and other groups requesting that the so-called Risk Evaluation Mitigation Strategy (REMS) restrictions be removed from mifepristone labeling.  Despite mifepristone’s excellent safety profile, since it was first approved by the FDA over 20 years ago, the drug has been subject to numerous additional restrictions that block access to essential health care and disproportionately harm people who already face health disparities and barriers to accessing care. While the lifting of the in-person dispensing requirement is a significant victory in making a safe and medically necessary medication more accessible by paving the way for telehealth abortion care, the FDA did not remove all of the REMS restrictions. The FDA maintained a requirement that patients sign a special form in order to be prescribed mifepristone and continues to require that health care professionals complete an additional and medically unnecessary self-certification in order to prescribe and dispense it.

For more than 20 years, mifepristone has offered a safe and effective means of ending a pregnancy. Mifepristone is also used in miscarriage management.  The CAFP, along with other leading medical groups — including the American College of Obstetricians and Gynecologists (ACOG), the American Medical Association (AMA), and the American Academy of Family Physicians (AAFP) — has long opposed the FDA’s restrictions on mifepristone because they are not evidence based, do not improve safety, and only create barriers to time-sensitive care. While we are pleased that the FDA has permanently lifted some access restrictions, it is disappointing that the FDA fell short of repealing all of the medically unnecessary restrictions on mifepristone.

The CAFP recognizes that restricting access to comprehensive reproductive health services--including abortion--disproportionately disadvantages people of color, low-income individuals, rural residents, and other vulnerable populations. The COVID-19 pandemic has only served to highlight the inequities in health care access that exist in America. While the lifting of the in person dispensing requirement might have helped patients such as the teen from Barstow, so much more must still be done to address access to essential reproductive health services.

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