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The disproportionate burdens of the mifepristone REMS

      Of the people who need abortion care in the United States every year, 75% are poor or living on low-incomes and approximately 60% are Black, Indigenous, and other people of color [
      • Jerman J.
      • Jones R.K.
      • Onda T.
      Characteristics of U.S. abortion patients in 2014 and changes since 2008.
      ]. Black, Indigenous, and other people of color face profound inequities in accessing essential health care as a result of a long history of systemic racism and discrimination [
      • Prather C.
      • Fuller T.R.
      • Jeffries W.L.
      • Marshall K.J.
      • Howell A.V.
      Racism, African American women, and their sexual and reproductive health: a review of historical and contemporary evidence and implications for health equity.
      ]. Accessing abortion is no different. Further, due to the stark racial disparities in maternal mortality and morbidity in the United States, Black and Indigenous people who cannot access the abortion care they need confront unconscionably elevated risks in carrying a pregnancy to term [
      The National Academies of Sciences, Engineering, Medicine
      The safety and quality of abortion care in the United States.
      ,
      • Luke A.A.
      • Huang K.
      • Lindley K.J.
      • Carter E.B.
      • Maddox K.E.
      Severe maternal morbidity, race, and rurality: trends using the national inpatient sample, 2012-2017.
      ,
      • Warren K.
      Native American women tackle high rate of maternal mortality, U.S.
      ]. Over the past year, the COVID-19 pandemic has only laid bare and deepened existing health care inequities [
      • Lindberg L.D.
      • VandeVusse A.
      • Mueller J.
      • Kirstein M.
      Early impacts of the COVID-19 pandemic, findings from the 2020 Guttmacher survey of reproductive health experiences.
      ]. Unfortunately, legal barriers to abortion access at the state and federal levels exacerbate these inequities. Among these barriers are the U.S. Food and Drug Administration's (“FDA”) Risk Evaluation and Mitigation Strategy (“REMS”) restrictions for mifepristone—1 of 2 drugs used to end early pregnancy and manage a miscarriage. This Spring, the FDA announced its intention to exercise enforcement discretion for the in-person dispensing requirement of the REMS during the public health emergency [

      Letter from Janet Woodcock to Maureen Phipps and William Grobman (Apr 12, 2021). [Accessed May 10, 2021]. Available from: https://www.aclu.org/letter/fda-response-acog-april-2021.

      ]. This change, although welcome, is temporary and applies only to one of the REMS restrictions. In May, the FDA stated its intention to conduct a long-awaited review of the REMS as a whole. As long as the REMS remain in place, it will unnecessarily burden access to safe medication for abortion and miscarriage care. Permanently removing the REMS in its entirety is therefore critical to reducing the disproportionate harms of abortion restrictions on communities of color and advancing equity in and access to timely and essential reproductive health care.

      Keywords

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