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For Medication Abortion, Science Should Guide Policy

  • Susan F. Wood
    Correspondence
    Correspondence to: Susan F. Wood, PhD, Department of Health Policy and Management Milken Institute School of Public Health, George Washington University, 950 New Hampshire Avenue NW, 6th Floor, Washington, DC 20052. Phone: +1-202-994-4171.
    Affiliations
    Jacobs Institute of Women's Health, Milken Institute School of Public Health, George Washington University, Washington, DC

    Department of Health Policy and Management, Milken Institute School of Public Health, George Washington University, Washington, DC
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  • Liz Borkowski
    Affiliations
    Jacobs Institute of Women's Health, Milken Institute School of Public Health, George Washington University, Washington, DC

    Department of Health Policy and Management, Milken Institute School of Public Health, George Washington University, Washington, DC
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  • Julia Strasser
    Affiliations
    Jacobs Institute of Women's Health, Milken Institute School of Public Health, George Washington University, Washington, DC

    Department of Health Policy and Management, Milken Institute School of Public Health, George Washington University, Washington, DC
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  • Amy Allina
    Affiliations
    Jacobs Institute of Women's Health, Milken Institute School of Public Health, George Washington University, Washington, DC
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      The U.S. Food and Drug Administration (FDA) approval of an updated label for the abortion drug Mifeprex in March 2016 (

      Food and Drug Administration (FDA). (2016a). Supplement approval [letter to Danco Laboratories, LLC]. Available: www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020687Orig1s020ltr.pdf. Accessed: April 8, 2016.

      ) marked an important step for access for abortion care and for evidence-based policy. Since the drug's initial approval in 2000, a strong and growing body of research has demonstrated the safety of medication abortion and supported several advances in medication abortion procedures, including changes to medication dosages and requirements for in-person office visits (

      Borkowski, L., Strasser, J., Allina, A., & Wood, S. (2015). Medication abortion: Overview of research & policy in the United States. Available: http://publichealth.gwu.edu/sites/default/files/Medication_Abortion_white_paper.pdf. Accessed: March 18, 2016.

      ). The FDA's recent approval of the revised label submitted by manufacturer Danco Laboratories, LLC, represents the regulatory agency's recognition of the scientific evidence. A science-based FDA decision about a drug should be an unremarkable development, but in this case it serves to highlight problematic state laws that limit women's access to medication abortion based on a claim of health protection, despite strong evidence that the laws' requirements are unnecessary and, in some cases, unethical.
      Among these laws are requirements that the procedure be performed precisely according to the FDA label, unless a statute allows for specific variations. Such laws are in force in North Dakota, Ohio, and Texas, and courts have prevented them from taking effect in Arizona, Arkansas, and Oklahoma (

      Guttmacher Institute. (2016). State policies in brief: medication abortion, as of March 1, 2016. Available: www.guttmacher.org/statecenter/spibs/spib_MA.pdf. Accessed: March 18, 2016.

      ). Until the FDA's approval in March 2016 of a revised Mifeprex label, providers in North Dakota, Ohio, and Texas had to adhere to an outdated protocol that presented barriers to high quality, accessible care. Although the FDA's decision reduces those barriers, it does not change the fact that several states have adopted these and other laws that limit providers' ability to shape their practice based on evidence and best practice—and, in some cases, require providers to make statements whose content is based solely on conjecture rather than science or clinical knowledge. If lawmakers truly want to advance women's health through legislation regarding medication abortion, they should understand the relevant scientific findings and base their policy proposals on evidence.
      On March 31, 2016, 1 day after the FDA announced its approval of the new Mifeprex label, Arizona Governor Doug Ducey signed into law a bill that requires medication abortion to be provided according to the label that existed on December 31, 2015 (
      • Eckholm E.
      Gov. Doug Ducey of Arizona signs abortion drug bill that skirts new F.D.A. protocol.
      ), which was the original label approved in 2000, described below. Although the law may not withstand a likely court challenge, the fact that a state would mandate such obviously outdated practices is alarming and highlights the growing chasm between science and policy in parts of the country.

      Important Changes to the Mifeprex Label

      The FDA approved the antiprogestin mifepristone (brand name Mifeprex) for use as an abortifacient in combination with the prostaglandin misoprostol in 2000. Since its approval, mifepristone's safety record has remained strong; the mortality rate for medication abortion is approximately 1 per 100,000, which is slightly higher than the mortality rate for surgical abortion, but significantly lower than the maternal mortality rate for women bringing their pregnancies to term (9.8 per 100,000;
      • Beal M.W.
      Update on medication abortion.
      ). Risks of fatal complications in abortions (both surgical and medical) remain very low, but they increase as gestation advances (
      • Zane S.
      • Creanga A.A.
      • Berg C.J.
      • Pazol K.
      • Suchdev D.B.
      • Jamieson D.J.
      • Callaghan W.M.
      Abortion-related mortality in the United States: 1998–2010.
      ). In 2011, nearly 240,000 medication abortions using mifepristone were performed in the United States, and they accounted for 23% of non-hospital abortion procedures in 2011 (
      • Jones R.K.
      • Jerman J.
      Abortion incidence and service availability in the United States, 2011.
      ).
      Mifeprex approval and its original label were based on the protocol used during pre-approval clinical trials in the 1980s and 1990s, but knowledge and practice for safe and effective medication abortion quickly advanced beyond what the original label specified (

      Borkowski, L., Strasser, J., Allina, A., & Wood, S. (2015). Medication abortion: Overview of research & policy in the United States. Available: http://publichealth.gwu.edu/sites/default/files/Medication_Abortion_white_paper.pdf. Accessed: March 18, 2016.

      ,
      • Britton L.
      • Bryant A.
      When off-label is illegal: Implications of mandating the FDA-approved protocol for mifepristone-induced abortions.
      ,
      • Cleland K.
      • Smith N.
      Aligning mifepristone regulation with evidence: Driving policy change using 15 years of excellent safety data.
      ). The March 2016 label adopts several of the evidence-based variations that are already in widespread use and recognized as standard clinical practice, including changing the drug dosage to 200 mg of oral mifepristone and 800 μg of buccal misoprostol (

      Food and Drug Administration (FDA). (2016b). Mifeprex Label [updated March 2016]. Available: www.accessdata.fda.gov/drugsatfda_docs/label/2016/020687s020lbl.pdf. Accessed: April 8, 2016.

      ). The use of 200 mg of mifepristone rather than the 600 mg specified in the original label had long been recommended by the World Health Organization, the American College of Obstetricians and Gynecologists (ACOG), the Society of Family Planning, and the Planned Parenthood Federation of America (
      • Cleland K.
      • Smith N.
      Aligning mifepristone regulation with evidence: Driving policy change using 15 years of excellent safety data.
      ). A 2014 ACOG practice bulletin notes that regimens using 200 mg of mifepristone “have similar efficacy and lower costs” than those involving 600 mg and states, “Based on efficacy and the adverse effect profile, evidence-based protocols for medical abortion are superior” to the regimen on the original label (
      American College of Obstetricians and Gynecologists (ACOG)
      Practice Bulletin No. 143: Medical management of first-trimester abortion.
      ).
      Another important change to the label is updating the gestational limit for medication abortion from 49 days to 70 (

      Food and Drug Administration (FDA). (2016b). Mifeprex Label [updated March 2016]. Available: www.accessdata.fda.gov/drugsatfda_docs/label/2016/020687s020lbl.pdf. Accessed: April 8, 2016.

      ). A survey of abortion providers regarding their 2011 practices asked whether providers of medication abortion offered it up to 63 days' gestation, and most indicated that they did (
      • Jones R.K.
      • Jerman J.
      Abortion incidence and service availability in the United States, 2011.
      ). Since 2011, several large studies have demonstrated the safety and efficacy of the evidence-based protocol for gestations of up to 70 days (
      • Abbas D.
      • Chong E.
      • Raymond E.G.
      Outpatient medical abortion is safe and effective through 70 days gestation.
      ,
      • Bracken H.
      • Dabash R.
      • Tsertsvadze G.
      • Posohova S.
      • Shah M.
      • Hajri S.
      • Winikoff B.
      A two-pill sublingual misoprostol outpatient regimen following mifepristone for medical abortion through 70 days' LMP: A prospective comparative open-label trial.
      ,
      • Sanhueza Smith P.
      • Pena M.
      • Dzuba I.G.
      • Garcia Martinez M.L.
      • Arangure Peraza A.G.
      • Bousieguez M.
      • Winikoff B.
      Safety, efficacy and acceptability of outpatient mifepristone-misoprostol medical abortion through 70 days since last menstrual period in public sector facilities in Mexico City.
      ,
      • Winikoff B.
      • Dzuba I.G.
      • Chong E.
      • Goldberg A.B.
      • Lichtenberg E.S.
      • Ball C.
      • Swica Y.
      Extending outpatient medical abortion services through 70 days of gestational age.
      ). The new label reflects this recent evidence.
      The new label also removes two specifications: 1) that women must return to providers' offices 2 days after receiving mifepristone to take misoprostol, the second drug in the regimen and 2) that women complete their clinical follow-up in person (

      Food and Drug Administration (FDA). (2005). Mifeprex prescribing information. Available: www.accessdata.fda.gov/drugsatfda_docs/label/2005/020687s013lbl.pdf. Accessed: September 16, 2015.

      ,

      Food and Drug Administration (FDA). (2016b). Mifeprex Label [updated March 2016]. Available: www.accessdata.fda.gov/drugsatfda_docs/label/2016/020687s020lbl.pdf. Accessed: April 8, 2016.

      ). Allowing women to take misoprostol on their own schedules and without returning to a provider's office can reduce women's logistical barriers as well as costs for transportation, time off work, or childcare; for years, many providers have been following protocols permitting home use of misoprostol, and extensive evidence demonstrates the safety of doing so (
      • Clark W.H.
      • Gold M.
      • Grossman D.
      • Winikoff B.
      Can mifepristone medical abortion be simplified? A review of the evidence and questions for future research.
      ,
      • Cleland K.
      • Creinin M.D.
      • Nucatola D.
      • Nshom M.
      • Trussell J.
      Significant adverse events and outcomes after medical abortion.
      ,
      • Wiegerinck M.M.
      • Jones H.E.
      • O'Connell K.
      • Lichtenberg E.S.
      • Paul M.
      • Westhoff C.L.
      Medical abortion practices: A survey of National Abortion Federation members in the United States.
      ). Alternatives to following up in person with medication abortion providers to confirm abortion completion include comparing baseline and post-abortion measurements of human chorionic gonadotropin, a hormone women's bodies produce during pregnancy. For instance, a woman can have blood drawn when she is prescribed mifepristone and visit a local laboratory for a second blood draw 1 to 2 weeks later; the provider can contact the woman by phone after receiving her laboratory report (
      American College of Obstetricians and Gynecologists (ACOG)
      Practice Bulletin No. 143: Medical management of first-trimester abortion.
      ). Although this still requires an in-person visit, laboratories may be more conveniently located than abortion providers and may offer extended hours or drop-in options. Some providers are already using this and other variations on in-person follow-up (

      Borkowski, L., Strasser, J., Allina, A., & Wood, S. (2015). Medication abortion: Overview of research & policy in the United States. Available: http://publichealth.gwu.edu/sites/default/files/Medication_Abortion_white_paper.pdf. Accessed: March 18, 2016.

      ,
      • Horning E.L.
      • Chen B.A.
      • Meyn L.A.
      • Creinin M.D.
      Comparison of medical abortion follow-up with serum human chorionic gonadotropin testing and in-office assessment.
      ), and research into a range of variations is ongoing. By removing the specification for patients to return to their providers to confirm abortion completion, the updated label allows for evolving evidence-based practice on follow-up visits.
      Removing the requirement for in-person visits to abortion providers for misoprostol administration and follow-up can also allow providers to re-allocate limited resources previously devoted to these visits. Another change to the label, the removal of the specification that mifepristone be administered “by or under the supervision of a physician” (

      Food and Drug Administration (FDA). (2005). Mifeprex prescribing information. Available: www.accessdata.fda.gov/drugsatfda_docs/label/2005/020687s013lbl.pdf. Accessed: September 16, 2015.

      ,

      Food and Drug Administration (FDA). (2016b). Mifeprex Label [updated March 2016]. Available: www.accessdata.fda.gov/drugsatfda_docs/label/2016/020687s020lbl.pdf. Accessed: April 8, 2016.

      ), also increases provider flexibility. Research demonstrates that medication abortions performed by mid-level providers (MLPs), such as nurse practitioners, nurse-midwives, and physician assistants, achieve similar safety and efficacy results to those by physicians (
      • Barnard S.
      • Kim C.
      • Park M.H.
      • Ngo T.D.
      Doctors or mid-level providers for abortion.
      ). Ensuring that MLPs have the legal authority and training to provide medication abortions can increase access to safe abortion services in areas with few physicians, such as rural areas where advanced practice clinicians but not obstetricians or gynecologists are located (
      • Foster A.M.
      • Jackson C.B.
      • LaRoche K.J.
      • Simmonds K.
      • Taylor D.
      From qualified physician to licensed health care professional: The time has come to change mifepristone's label.
      ,
      • Taylor D.
      • Safriet B.
      • Weitz T.
      When politics trumps evidence: Legislative or regulatory exclusion of abortion from advanced practice clinician scope of practice.
      ). It can also enhance the cost effectiveness of abortion care and allow providers to offer services to more women (
      • Yarnall J.
      • Swica Y.
      • Winikoff B.
      Non-physician clinicians can safely provide first trimester medical abortion.
      ).
      The revised label still includes requirements that are far more restrictive than typical requirements for prescription drugs of a similar safety profile, including mandating signed provider and patient agreements. Distribution is still tightly controlled, and access could improve if women could obtain Mifeprex by prescription from pharmacies rather than from a provider, who must keep the drug in stock and be a registered prescriber. Overall, however, the updated label does a far better job reflecting current research on safety and efficacy, and it allows for greater flexibility that can improve women's access to abortion care.

      States Limiting Providers' Ability to Offer Evidence-Based Care

      Although the updated Mifeprex label allows MLPs to provide medication abortions with or without physician supervision as permitted by state law, as of March 2016 thirty-seven states allow only licensed physicians to provide medication abortion, despite research showing that MLPs can provide this service safely and effectively.
      Thirty-eight (38) states allow only licensed physicians to provide surgical abortion; New Jersey is the only state that limits surgical but not medication abortion to licensed physicians (

      Guttmacher Institute. (2016). State policies in brief: medication abortion, as of March 1, 2016. Available: www.guttmacher.org/statecenter/spibs/spib_MA.pdf. Accessed: March 18, 2016.

      ).
      Eighteen states require the clinician to be physically present for the medication abortion process (

      Guttmacher Institute. (2016). State policies in brief: medication abortion, as of March 1, 2016. Available: www.guttmacher.org/statecenter/spibs/spib_MA.pdf. Accessed: March 18, 2016.

      ). Requirements that the physician be physically present effectively prohibit the use of telemedicine for the medication abortion process. The telemedicine option, which allows geographically distant patients and providers to communicate electronically, may become increasingly important if more clinics providing abortion are required to close owing to state laws that reduce abortion availability. Where it is not prohibited, telemedicine can present a promising option for women in rural or other health professional shortage areas, where travelling to a clinic for multiple visits may require days off from work or even overnight stays hundreds of miles from home. After clinics in Iowa began offering medication abortions via telemedicine, researchers found that safety and efficacy outcomes for telemedicine and face-to-face procedures were similar (
      • Grossman D.
      • Grindlay K.
      • Buchacker T.
      • Lane K.
      • Blanchard K.
      Effectiveness and acceptability of medical abortion provided through telemedicine.
      ), and that women receiving abortions were more likely to obtain them before 13 weeks' gestation (
      • Grossman D.
      • Grindlay K.
      • Buchacker T.
      • Potter J.E.
      • Schmertmann C.P.
      Changes in service delivery patterns after introduction of telemedicine provision of medical abortion in Iowa.
      ).
      Limitations on who can provide medication abortion care and how will likely have an immediate and significant impact on women's access to these services. A recent analysis of trends in mifepristone use in four states—two with very restrictive medication abortion laws and two with some of the least restrictive laws—found that the overall abortion rate decreased in all four states during the 10-year time period of study. However, in more restrictive states, mifepristone use declined significantly after the passage of restrictive medication abortion laws, whereas in less restrictive states, mifepristone use increased during the same time period (
      • Sheldon W.R.
      • Winikoff B.
      Mifepristone label laws and trends in use: Recent experiences in four US states.
      ).

      “Reversal” of Medication Abortion

      In addition to restricting the ways providers can offer medication abortion, some states have enacted legislation mandating that providers tell patients it may be possible to reverse a medication abortion after they have taken the initial dose of drugs. The claim is that, if a woman is treated with high doses of progesterone after taking mifepristone (which is an anti-progestin) and not taking misoprostol, she might halt the abortion process and allow her pregnancy to continue.
      Progesterone is a naturally occurring hormone, and synthetic versions of it are used during pregnancy for several established and tested clinical purposes. These include prevention of preterm birth and supplementing other hormones used in assisted reproductive technologies (
      • Grossman D.
      • White K.
      • Harris L.
      • Reeves M.
      • Blumenthal P.D.
      • Winikoff B.
      • Grimes D.A.
      Continuing pregnancy after mifepristone and “reversal” of first-trimester medical abortion: A systematic review.
      ). However, we have found no credible evidence to support the claim that progesterone can reverse a medication abortion. A recent systematic literature review found only one article that examined the question of medication abortion reversal on a small number of cases, and its methods were highly flawed (
      • Grossman D.
      • White K.
      • Harris L.
      • Reeves M.
      • Blumenthal P.D.
      • Winikoff B.
      • Grimes D.A.
      Continuing pregnancy after mifepristone and “reversal” of first-trimester medical abortion: A systematic review.
      ).
      In more rigorous studies of taking mifepristone alone (but not taking either misoprostol or progesterone), the proportions of participants with continuing pregnancies ranged from 8% to 46% (
      • Grossman D.
      • White K.
      • Harris L.
      • Reeves M.
      • Blumenthal P.D.
      • Winikoff B.
      • Grimes D.A.
      Continuing pregnancy after mifepristone and “reversal” of first-trimester medical abortion: A systematic review.
      ). This finding is important because women who had no additional intervention after taking mifepristone (e.g., no progesterone) but no misoprostol may have been likely to continue their pregnancies in nearly one-half of all cases. Thus, these continuing pregnancies seen by women who did take progesterone cannot be assumed to be owing to reversing the effects of mifepristone, as claimed by the original study authors.
      Despite the lack of an evidence base, both Arizona and Arkansas have enacted laws requiring that women receive information from their physicians on the possibility of reversing a medication abortion (
      • Somashekhar S.
      In Arizona, Arkansas, women must be told that abortion can be ‘reversed’. Washington Post.
      ), and South Dakota has passed a law requiring physicians to provide women with information stating, “That even after a pregnant mother [sic] takes Mifepristone it is still possible to discontinue a drug-induced abortion by not taking the prescribed Misoprostol” (

      Anderson, M. (2016). Abortion ‘reversal’ misinformation is South Dakota policy, thanks to GOP. Rewire. Available: https://rewire.news/article/2016/04/04/abortion-misinformation-south-dakota-policy/. Accessed: March 18, 2016.

      ,

      South Dakota Legislature. (2016). House Bill 1157 (2016 Session). Available: http://legis.sd.gov/Legislative_Session/Bills/Bill.aspx?File=HB1157ENR.htm&Session=2016. Accessed: April 8, 2016.

      ). The Arizona law has been temporarily enjoined because of a pending lawsuit filed in federal court (

      Guttmacher Institute. (2015). Laws affecting reproductive health and rights: State trends at midyear, 2015. Available: www.guttmacher.org/media/inthenews/2015/07/01/index.html. Accessed: October 28, 2015.

      ). Legislation that purports to offer women information while ignoring such a dearth of scientific evidence is unethical and dangerous. Some physicians will not in good conscience be able to provide information about medication abortion that contradicts their clinical knowledge and judgment (
      • Grossman D.
      • White K.
      • Harris L.
      • Reeves M.
      • Blumenthal P.D.
      • Winikoff B.
      • Grimes D.A.
      Continuing pregnancy after mifepristone and “reversal” of first-trimester medical abortion: A systematic review.
      ). Women in these states seeking medication abortions should have accurate, complete information about the procedure, but will instead receive the opposite.

      Conclusion

      Evidence shows that reducing barriers to medication abortion can allow more women to receive abortion services early in their pregnancies, when risks are lowest. Although the FDA's approval of the revised Mifeprex label marks an important first step toward improving access to high-quality abortion care, the change came many years after research demonstrated the safety and efficacy of widely used evidence-based protocols. Meanwhile, states took unusual steps: requiring health care providers to follow the drug label and preventing their residents from accessing care based on the latest evidence and best practice.
      The additional state policies discussed create clear barriers to the adoption of evidence-based practices that could improve access and health outcomes. Laws requiring clinicians to provide a woman with factually incorrect information on the reversability of medication abortion are especially alarming. Lawmakers should not pass legislation with the expressed purpose of safeguarding women's health when evidence demonstrates they are likely to have the opposite effect. Those who are truly committed to safeguarding women's health should ensure that policies affecting medication abortion services are grounded in the strong body of evidence demonstrating the safety and efficacy of evidence-based protocols, and of allowing all licensed, trained, and qualified providers to offer medication abortion, whether in a clinic, by writing a prescription to be filled at a pharmacy, or via telemedicine.

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      Biography

      Susan F. Wood, PhD, is Associate Professor of Health Policy and Management and Environmental and Occupational Health and Director of the Jacobs Institute of Women's Health, Milken Institute School of Public Health, George Washington University.

      Biography

      Liz Borkowski, MPH, is managing editor of Women's Health Issues and a researcher in the Department of Health Policy and Management, Milken Institute School of Public Health, George Washington University. Her interests include reproductive health, paid leave, and the ACA.

      Biography

      Julia Strasser, MPH, is a doctoral student and Senior Research Associate in the Department of Health Policy and Management, Milken Institute School of Public Health, George Washington University. Her interests include reproductive health, safety net services, and public financing.

      Biography

      Amy Allina, BA, is a senior leader in policy advocacy and program development with expertise in women's health and rights, regulation of drugs and medical devices, and health care coverage. She works with Bridging the Divide, Jacobs Institute of Women's Health.