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Contraception Special Issue on the mifepristone Risk Evaluation and Mitigation Strategy (REMS)

      The safety and efficacy of mifepristone for medication abortion have been well-established during more than 20 years of use in the United States (US) [
      • Gambir K
      • Kim C
      • Necastro KA
      • Ganatra B
      • Ngo TD.
      Self-administered versus provider-administered medical abortion.
      ]. Yet, in the US, the Food and Drug Administration (FDA) regulates mifepristone by a Risk Evaluation and Mitigation Strategy (REMS) and associated Elements to Assure Safe Use (ETASU) [
      • Raymond EG
      • Blanchard K
      • Blumenthal PD
      • Cleland K
      • Foster AM
      • Gold M
      • et al.
      Sixteen years of overregulation: time to unburden Mifeprex.
      ]. These regulations place constraints on where, and by whom, mifepristone may be dispensed. Mifepristone must be dispensed directly from healthcare facilities, not retail pharmacies; providers must register as certified prescribers, and patients must sign an agreement that is separate from standard informed consent. A growing body of evidence demonstrates that the existing restrictions are unnecessary and overly burdensome, yet these regulations remain [
      • Henney JE
      • Gayle HD.
      Time to Reevaluate U.S. Mifepristone Restrictions.
      ].
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      References

        • Gambir K
        • Kim C
        • Necastro KA
        • Ganatra B
        • Ngo TD.
        Self-administered versus provider-administered medical abortion.
        Cochrane Database Syst Rev. 2020; : 2020
        • Raymond EG
        • Blanchard K
        • Blumenthal PD
        • Cleland K
        • Foster AM
        • Gold M
        • et al.
        Sixteen years of overregulation: time to unburden Mifeprex.
        The New England Journal of Medicine. 2017; 376: 790-794
        • Henney JE
        • Gayle HD.
        Time to Reevaluate U.S. Mifepristone Restrictions.
        N Engl J Med. 2019; 381: 597-598
        • Upadhyay UD
        • Schroeder R
        • Roberts SCM.
        Adoption of no-test and telehealth medication abortion care among independent abortion providers in response to COVID-19.
        Contracept X. 2020; 2
      1. Am. Coll. of Obstetricians & Gynecologists v. U.S. Food & Drug Admin. United States District Court, District of Maryland. 472 F. Supp. 3d 183, 2020.

        • Roberts C.
        Food and Drug Administration, et al., vs American College of Obstetricians and Gynecologists et al..
        United States Supreme Court. 2021;
      2. Woodcock J. Letter to American College of Obstetricians and Gynecologists et al. from the United States Food and Drug Administration, 2021. Available at: https://www.aclu.org/letter/fda-response-acog-april-2021, accessed May 13, 2021.

      3. Graham T. Chelius et al. vs Xavier Becerra, Secretary US DHHS et al. Joint Motion to Stay Case Pending Agency Review. 2021. Available at: https://www.aclu.org/legal-document/joint-motion-stay-case-pending-agency-review, accessed May 13, 2021.

      4. Dohm J and Ji M. An introduction to Risk Evaluation and Mitigation Strategies 2021, 104: 4-7.

      5. Serpico J. Abortion exceptionalism and the mifepristone REMS 2021, 104: 8-11.

      6. Kaye J, Reeves R, Chaiten L. The mifepristone REMS: a needless and unlawful barrier to care 2021, 104: 12-15.

      7. Thompson A, Singh D, Ghorashi A, Donovan M, Ma J, Rikelman J. The disproportionate burdens of the mifepristone REMS 2021, 104: 16-19.

      8. Raidoo S, Kaneshiro B, Stowers P. Guam: the US territory where America's day begins but abortion access is still in the dark 2021, 104: 33-35.

      9. Chong E, Shochet T, Raymond E, Platais I, Anger H, Raidoo S, et al. Expansion of a direct-to-patient telemedicine abortion service in the United States and experience during the COVID-19 pandemic 2021, 104: 43-48.

      10. Kerestes C, Murayama S, Tyson J, Natavio M, Seamon E, Raidoo S, et al. Provision of medication abortion in Hawai‘i during COVID-19: Practical experience with multiple care delivery models

      11. Tschann M, Ly E, Hillard S, Lange H. Changes to medication abortion clinical practices in response to the COVID-19 pandemic 2021, 104: 77-81.

      12. Godfrey E, Fiastro A, Jacob-Files E, Coeytaux F, Wells E, Ruben M, et al. Factors associated with successful implementation of telehealth abortion in four United States clinical practice settings 2021, 104: 82-91.

      13. LaRoche K, Jozkowski K, Crawford B, Haus K. Attitudes of US adults toward using telemedicine to prescribe medication abortion during COVID-19: a mixed methods study 2021, 104: 104-110.

      14. Daniel S, Schulkin J, Grossman D. Obstetrician-gynecologist willingness to provide medication abortion with removal of the in-person dispensing requirement for mifepristone 2021, 104: 73-76.

      15. Calloway D, Stulberg D, Janiak E. Mifepristone restrictions and primary care: breaking the cycle of stigma through a learning collaborative model in the United States 2021, 104: 24-28.

      16. Flynn A, Shorter J, Roe A, Sonalkar S, Schreiber C. The burden of the Risk Evaluation and Mitigation Strategy (REMS) on providers and patients experiencing early pregnancy loss: a commentary 2021, 104: 29-30.

      17. Srinivasulu S, Yavari R, Brubaker L, Riker L, Prine L, Rubin S. US clinicians’ perspectives on how mifepristone regulations affect access to medication abortion and early pregnancy loss care in primary care 2021, 104: 77-81.

      18. Glaser K and Whitehair J. Missing mifepristone at Tribal health facilities serving Native Americans 2021, 104: 36-37.

      19. Stone R and Rafie S. Medication abortion: Advocating for mifepristone dispensing by pharmacists 2021, 104: 31-32.

      20. Rasmussen K, Janiak E, Cottrill A, Stulberg D. Expanding access to medication abortion through pharmacy dispensing of mifepristone: Primary care perspectives from Illinois 2021, 104: 98-103.

      21. Meurice M, Whitehouse K, Blaylock R, Chang J, Lohr P. Client satisfaction and experience of telemedicine and home use of mifepristone and misoprostol for abortion up to 10 weeks’ gestation at British Pregnancy Advisory Service: a cross-sectional evaluation 2021, 104: 61-66.

      22. Kerestes C, Delafield R, Elia J, Chong E, Kaneshiro B, Soon R. “It was close enough, but it wasn't close enough”: a qualitative exploration of the impact of direct-to-patient telemedicine abortion on access to abortion care 2021, 104: 67-72.

      23. Godfrey E, Thayer E, Fiastro A, Aiken ARA, Gomperts R. Family medicine provision of online medication abortion in three US states during COVID-19 2021, 104: 54-60.

      24. Thompson T, Price J, Carrion F. Changes needed in Medicaid coverage and reimbursement to meet an evolving abortion care landscape 2021, 104: 20-23.

      25. Mello K, Smith M, Hill B, Chakraborty P, Rivlin K, Bessett D, et al. Federal, state, and institutional barriers to the expansion of medication and telemedicine abortion services in Ohio, Kentucky, and West Virginia during the COVID-19 pandemic 2021, 104: 11-116.

      26. Mark A, Foster A, Perritt J. The future of abortion is now: mifepristone by mail and in-clinic abortion access in the United States 2021, 104: 38-42.