The next two decades of mifepristone at FDA: History as destiny,


      Congressional and presidential records reveal a consistent pattern of political intercession with the regulatory authority of the Food and Drug Administration (FDA) over the approval and labeling of mifepristone (RU-486). This pattern is unlikely to abate any time soon. It is against this backdrop that we examine herein the ongoing legislative and legal disputes over mifepristone at a point in time which is just beyond the 20th anniversary of its approval by the FDA “for the medical termination of intrauterine pregnancy.”


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        • Teutsch G.
        • Costerousse G.
        • Deraedt R.
        • Benzoni J.
        • Fortin M.
        • Philibert D.
        • et al.
        17 alpha-alkynyl-11 beta, 17-dihydroxyandrostane derivatives: a new class of potent glucocorticoids.
        Steroids. 1981; 38: 651-665
        • Bélanger A.
        • Philibert D.
        • Teutsch G.
        Regio and stereospecific synthesis of 11 beta-substituted 19-norsteroids. Influence of 11 beta-substitution on progesterone receptor affinity - (1).
        Steroids. 1981; 37: 361-382
        • Healy D.L.
        • Baulieu E.E.
        • Hodgen G.D.
        Induction of menstruation by an antiprogesterone steroid (RU 486) in primates: site of action, dose-response relationships, and hormonal effects.
        Fertil Steril. 1983; 40: 253-257
        • Herrmann W.
        • Wyss R.
        • Riondel A.
        • Philibert D.
        • Teutsch G.
        • Sakiz E.
        • et al.
        The effect of an antiprogesterone steroid in women: interruption of the menstrual cycle and early pregnancy.
        C R Seances Acad Sci III. 1982; 294: 933-938
        • Couzinet B.
        • Le Strat N.
        • Ulmann A.
        • Baulieu E.E.
        • Schaison G.
        • et al.
        Termination of early pregnancy by the progesterone antagonist RU 486 (mifepristone).
        N Engl J Med. 1986; 315: 1565-1570
        • Silvestre L.
        • Dubois C.
        • Renault M.
        • Rezvani Y.
        • Baulieu E.E.
        • Ulmann A.
        • et al.
        Voluntary interruption of pregnancy with mifepristone (RU 486) and a prostaglandin analogue: a large-scale French experience.
        N Engl J Med. 1990; 322: 645-648
        • Peyron R.
        • Aubény E.
        • Targosz V.
        • Silvestre L.
        • Renault M.
        • Elkik F.
        • et al.
        Early termination of pregnancy with mifepristone (RU 486) and the orally active prostaglandin misoprostol.
        N Engl J Med. 1993; 328: 1509-1513
        • El-Refaey H.
        • Rajasekar D.
        • Abdalla M.
        • Calder L.
        • Templeton A.
        • et al.
        Induction of abortion with mifepristone (RU 486) and oral or vaginal misoprostol.
        N Engl J Med. 1995; 332: 983-987
      1. Seelye, K.Q., Accord opens way for abortion pill in U.S. in 2 years. 1997. [Accessed September 1, 2021].

        • Spitz I.M.
        • Bardin C.W.
        • Benton L.
        • Robbins A.
        • et al.
        Early pregnancy termination with mifepristone and misoprostol in the United States.
        N Engl J Med. 1998; 338: 1241-1247
      2. CRS Report for Congress, Abortion: termination of early pregnancy with RU-486 (mifepristone). 2001.

      3. U.S. Food and Drug Administration, [email protected]: FDA-approved drugs. New Drug Application (NDA): 020687. DANCO LABS LLC. Mifeprex. 2000.;varApplNo=020687.

        • Beaman J.
        • Prifti C.
        • Schwarz E.B.
        • Sobota M.
        • et al.
        Medication to manage abortion and miscarriage.
        J Gen Intern Med. 2020; 35: 2398-2405
        • Joffe S.
        • Schroeder R.
        COVID-19, health care, and abortion exceptionalism in the United States.
        Perspect Sex Reprod Health. 2021; 53: 5-12
      4. United States Government Accountability Office, Food and Drug Administration. Approval and oversight of the drug Mifeprex. 2008.

      5. United States Government Accountability Office, Food and Drug Administration. Information on Mifeprex labeling changes and ongoing monitoring efforts. 2018.

      6. United States Government Accountability Office, Medicaid. CMS action needed to ensure compliance with abortion coverage requirements. 2019.

      7. Cunningham, P.C., Forsythe, C.D., Yingling, G.L., Citizen petition to the U.S. Food and Drug Administration. 1995.

      8. U.S. Food and Drug Administration, Reproductive Health Drugs Advisory Committee. New drug application for the use of mifepristone for interruption of early pregnancy. 1996.

      9. Sen. Barbara Boxer, Letter to Jane Henney, FDA Commissioner, June 9, 2000 (Document #6376). Rep. Tom Coburn. Letter to Jane Henney, FDA Commissioner. 2000 (Document #8020)

      10. Congressional Record, Proceedings and debates of the 105th Congress, Second Session. Vol. 144/No. 150. Exhibit 3. 1998

      11. Young, J., Abortion opponents renew call to pull RU-486. 2005.

      12. Clinton, W.J., Memorandum on Importation of RU-486. 1993.

        • Hogan J.A.
        The life of the abortion pill in the United States.
        Legal electronic document archive. Harvard Law School Library, Cambridge, MA2000 (
        • Charo A.R.
        A political history of RU-486.
        Biomedical politics. The National Academies Press, Washington, DC1991
        • Reichertz P.S.
        • Friend M.S.
        Hiding behind agency discretion: the Food and Drug Administration's personal use drug importation policy.
        Cornell J Law Public Policy. 2000; 9: 493-521
      13. Dornan, RK, Hyde, H, LaFalce, J, DeWine, M, Hunter, D, Blilely, T, Strangeland, A, Dannemeyer, B, Cox, C, Weber, VH, Clyde C. Letter to Frank Young, FDA Commissioner. 1989 (Document #5479-5480)

      14. Rep. Ron Wyden., Letters to David Kessler, FDA Commissioner. July 15, 1992; July 22, 1992; December 10, 1992; January 14, 1993; April 21, 1994 (Documents #5947, 5951, 5955, 5985, 2655)

      15. House of Representatives, 101st United States Congress. RU 486: the import ban and its effect on medical research. Hearing before the subcommittee on regulation, business opportunities, and energy of the committee on small business. 1990.

      16. Institute of Medicine. 1993. Clinical Applications ofMifepristone (RU486) and Other Antiprogestins: Assessing the Science and Recommending a Research Agenda. Washington,DC: The National Academies Press.

      17. Senate, 107th United States Congress. Nomination. Hearing before the Committee on Health, Education, Labor and Pensions on Tommy G. Thompson of Wisconsin to be Secretary of Health and Human Services. 2001.

      18. The New York Times, Thompson Says he will order a new review of abortion drug. 2001.

      19. House of Representatives, 109th United States Congress. RU 486: demonstrating a low standard for women's health? Hearing before the subcommittee on criminal justice drug policy and human resources of the committee on government reform. 2006.

        • Adashi E.Y.
        • Rajan R.S.
        • Cohen I.G.
        When science and politics collide: enhancing the FDA.
        Science. 2019; 364: 628-631
      20. U.S. Food & Drug Administration, Mifeprex (mifepristone) information. 2016.

      21. Kaiser Family Foundation, The availability & use of medication abortion. 2020.

      22. Guttmacher Institute, The public health implications of the FDA update to the medication abortion label. 2016.

        • Greene M.F.
        • Drazen J.M.
        A new label for mifepristone.
        N Engl J Med. 2016; 374: 2281-2282
        • Henney J.E.
        • Gayle H.D.
        Time to reevaluate U.S. mifepristone restrictions.
        N Engl J Med. 2019; 381: 597-598
        • Mifeprex REMS Study Group
        • Raymond E.G.
        • Blanchard K.
        • Blumenthal P.D.
        • Cleland K
        • Foster A.M.
        • Gold M.
        • Grossman D.
        • Pendergast M.K.
        • Westhoff C.L.
        • Winikoff B.
        Sixteen years of overregulation: time to unburden Mifeprex.
        N Engl J Med. 2017; 376: 790-794
        • National Academies of Sciences, Engineering, and Medicine
        The safety and quality of abortion care in the United States.
        The National Academies Press, Washington, DC2018
      23. American Civil Liberties Union, Chelius v. Azar. 2017.

      24. Congress of the United States, Letter to Robert Califf, FDA Commissioner. 2016.

      25. CONGRESS.GOV, H.R.4935 - Teleabortion Prevention Act of 2019. 2019.,

      26. CONGRESS.GOV, S.3252 - Teleabortion Prevention Act of 2020. 2020.

      27. ACLU, American College of Obstetricians & Gynecologists v. U.S. Food and Drug Administration. 2020.

      28. Supreme Court of the United States, Food and Drug Administration, et al. v. American College of Obstetricians and Gynecologists, et al. 2021. 2021.

      29. Warren, E., Murray,P., Baldwin, T., Letter to Stephen Hahn, FDA Commissioner. 2020

      30. The Hill, Reps. D Degette, Lee B, Schakowsky J, Pressley A. 20 years later, the FDA must lift restrictions on medication abortion care. 2020.

      31. Hyde-Smith C his letter was signed by 38 Senators and 121 Representatives; the full list is available here.

      32. Cruz, T, Cramer, K, Daines, S, Ernst, JK, Braun, M, Inhofe, JM, Wicker, RF, Enzi, MB, Rounds, MM, Loeffler, K, Lee, M, Portman, R, Hyde-Smith, C, Lankford, J, Roberts, P, Cotton, T, Crapo, M, Blackburn, M, Risch, JE, Hoeven, J, Letter to Stephen Hahn, FDA Commissioner. 2020.

      33. Maloney, CB, Pressley, A, Norton, EH, Ocasio-Cortez, A, Porter, K, Tlaib, R, Bush, C, Wasserman Shultz, D, Speier, J, Kelly, R, Lawrence, BL, Letter to Janet Woodcock, Acting FDA Commissioner. 2021.

      34. U.S. Food & Drug Administration, Letter of Acting FDA Commissioner Janet Woodcock to the American College of Obstetricians and Gynecologists. 2021.

        • Gostin L.O.
        • Parmet W.E.
        • Rosenbaum S
        Health policy in the Supreme Court and a new conservative majority.
        JAMA. 2020; 324: 2157-2158
      35. Guttmacher Institute, Medication abortion. 2020.

      36. Health Resources & Services Administration (HRSA), Health workforce. 2020.

        • Charo R.A.
        Whole women's victory - or not?.
        N Engl J Med. 2016; 375: 809-811
      37. Thomas, C., Kristina Box, Commissioner, Indiana Department of Health et al. v. Planned Parenthood of Indiana and Kentucky, Inc., et al. 2019.

        • Fox D.
        • Cohen I.G.
        • Adashi E.Y.
        June Medical Services v. Russo: the future of abortion access in the US.
        JAMA Health Forum. 2020; 1e201107
        • Cohen I.G.
        • Adashi E.Y.
        • Gostin L.O.
        The Supreme Court, the Texas Abortion Law (SB8), and the beginning of the end of Roe v Wade?.
        JAMA. 2021; 326: 1473-1474
      38. U.S. Food & Drug Administration, Mifeprex (mifepristone) information. 2021.