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Research Article| Volume 104, ISSUE 1, P12-15, July 2021

The mifepristone REMS: A needless and unlawful barrier to care✰

Published:April 27, 2021DOI:https://doi.org/10.1016/j.contraception.2021.04.025
The mifepristone REMS: A needless and unlawful barrier to care✰
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      Abstract

      Mifepristone (brand name Mifeprex) is a prescription drug that has been safely used in the United States for twenty years to end early pregnancies and, more recently, to treat early miscarriages. Although the U.S. Food and Drug Administration (FDA) acknowledges that mifepristone's safety and efficacy are “well-established by both research and experience” [

      U.S. Food & Drug Admin., Ctr. for Drug Eval. & Res., Application Number 020687Orig1s020: Medical Review(s) 12 (Mar. 2016), https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/020687Orig1s020MedR.pdf [hereinafter “Mifeprex 2016 Medical Review”].

      ], it imposes a Risk Evaluation and Mitigation Strategy (“REMS”) that severely restricts where, how, and from whom this medication can be obtained. Most notably, FDA requires that mifepristone be dispensed at a hospital, clinic, or medical office—not by mail or through a retail or mail-order pharmacy—even though patients can receive all evaluation and counseling via telemedicine and can self-administer the mifepristone tablet, unsupervised, at the location of their choice. Of more than 20,000 FDA-approved drugs [

      U.S. Food & Drug Admin., FDA at a Glance (Nov. 2020), https://www.fda.gov/media/143704/download.

      ], mifepristone is the only one FDA requires patients to pick up in a clinical setting even though they do not have to take it under clinical supervision [

      Am. Coll. of Obstetricians & Gynecologists v. FDA [hereinafter “ACOG v. FDA”], 472 F.Supp.3d 183, 191 (D. Md. 2020).

      ].
      FDA's singular restrictions on mifepristone are not only clinically unjustified, but unlawful. On behalf of leading medical associations, individual physicians, and reproductive justice advocates, our organization, the American Civil Liberties Union, has taken FDA to court—twice—because the agency's restrictions on mifepristone do not satisfy the strict constraints Congress established for REMS programs and erect profound and unnecessary barriers to care in violation of the U.S. Constitution.

      Keywords

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      References

      1. U.S. Food & Drug Admin., Ctr. for Drug Eval. & Res., Application Number 020687Orig1s020: Medical Review(s) 12 (Mar. 2016), https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/020687Orig1s020MedR.pdf [hereinafter “Mifeprex 2016 Medical Review”].

        View in Article

      2. U.S. Food & Drug Admin., FDA at a Glance (Nov. 2020), https://www.fda.gov/media/143704/download.

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      3. Am. Coll. of Obstetricians & Gynecologists v. FDA [hereinafter “ACOG v. FDA”], 472 F.Supp.3d 183, 191 (D. Md. 2020).

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      4. U.S. Food & Drug Admin., Development and Approval Process: Drugs (Oct. 2019), https://www.fda.gov/drugs/development-approval-process-drugs.

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      9. Food, Drug, and Cosmetic Act, 21 U.S.C. § 355-1(g).

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      10. U.S. Food & Drug Admin., Ctr. for Drug Eval. & Res., Final Risk Evaluation and Mitigation Strategy (REMS) Review: Mifeprex (Oct. 2013) [hereinafter “Mifeprex 2013 REMS Review”], Chelius v. Becerra, Dkt. 85-8.

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      11. U.S. Food & Drug Admin., Ctr. for Drug Eval. & Res., Application Number 020687Orig1s020: Risk Assessment and Risk Mitigation Review(s) Ref ID: 3909589 at 2 (Mar. 2016), https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/020687Orig1s020RiskR.pdf [hereinafter “Mifeprex 2016 REMS Review”].

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      12. Id., Ref ID: 3909589 at 3.

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      13. U.S. Food & Drug Admin., Ctr. for Drug Eval. & Res., Application Number 020687Orig1s020: Summary Review(s) 25 (Mar. 2016), https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/020687Orig1s020SumR.pdf [hereinafter ``Mifeprex 2016 Summary Review"].

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      18. Mifeprex 2016 Medical Review, at 47.

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      19. Mifeprex Labeling, at 16 (emphasis added).

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      20. Id. at 2.

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      23. Mifeprex 2013 Review, at 13.

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      24. Mifeprex 2016 REMS Review, Ref ID: 3909589 at 3.

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      29. See, e.g. Am. Coll. of Obstetricians & Gynecologists, Code of Professional Ethics of the American College of Obstetricians and Gynecologists 2 (Dec. 2018), https://www.acog.org/-/media/project/acog/acogorg/files/pdfs/acog-policies/code-of-professional-ethics-of-the-american-college-of-obstetricians-and-gynecologists.pdf (accessed 6 April 2021) (“The obstetrician-gynecologist should recognize the boundaries of his or her particular competencies and expertise and must provide only those services and use only those techniques for which he or she is qualified by education, training and experience.”).

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      30. Mifeprex 2016 REMS Review, Ref ID: 3909487.

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      31. Schreiber C, Creinin M, Atrio J, Sonalkar S, Ratcliffe S, Barnhart K. Mifepristone Pretreatment for the Medical Management of Early Pregnancy Loss. New Eng. J. Med. (2018). https://www.nejm.org/doi/full/10.1056/NEJMoa1715726.

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      32. Am. Coll. of Obstetricians & Gynecologists, Early Pregnancy Loss Practice Bulletin (Nov. 2018), https://www.acog.org/clinical/clinical-guidance/practice-bulletin/articles/2018/11/early-pregnancy-loss.

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      34. Daniel S, Schulkin J, Grossman D. Obstetrician-gynecologist willingness to provide medication abortion with removal of the in-person dispensing requirement for mifepristone. Contraception (available online April 1, 2021), https://www.sciencedirect.com/science/article/pii/S0010782421000986.

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      35. Chelius v. Becerra, Decl. of Charisse Loder, M.D., M.Sc., Dkt. 142-11, ¶¶7–21, 29–30.

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      36. The Plaintiffs in Chelius v. Becerra are Dr. Graham Chelius, M.D., the Society of Family Planning, and the California Academy of Family Physicians.

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      37. Jerman J, Jones R, Onda T, Characteristics of U.S. Abortion Patients in 2014 and Changes Since 2008, Guttmacher Inst. 5, 7 (2016), https://www.guttmacher.org/report/characteristics-us-abortion-patients-2014.

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      38. The Plaintiffs in ACOG v. FDA are the American College of Obstetricians and Gynecologists, the Council of University Chairs of Obstetrics and Gynecology, the New York State Academy of Family Physicians, SisterSong Women of Color Reproductive Justice Collective, and Dr. Honor MacNaughton, M.D.

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      39. ACOG v. FDA, 472 F. Supp.3d 183 (D. Md. 2020).

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      40. ACOG v. FDA, 141 S. Ct. 578 (2021).

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      41. Letter from Janet Woodcock, M.D., Acting Commissioner of Food & Drug Admin., to Maureen G. Phipps, M.D., M.P.H., FACOG, and William Grobman, M.D., M.B.A. (April 12, 2021), https://www.aclu.org/letter/fda-response-acog-april-2021.

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      42. Joint Motion to Stay Case Pending Agency Review, Chelius v. Becerra, Dkt. 148.

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      Article info

      Publication history

      Published online: April 27, 2021
      Accepted: April 21, 2021
      Received in revised form: April 21, 2021
      Received: February 15, 2021

      Footnotes

      Declaration of Competing Interest: None

      Identification

      DOI: https://doi.org/10.1016/j.contraception.2021.04.025

      Copyright

      © 2021 The Author(s). Published by Elsevier Inc. All rights reserved.

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