Removing the Mifeprex REMS was long overdue. Then a global pandemic began.

by Isabel Blalock

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Any conversation about making abortion care a literal, accessible right for everyone in this country — as opposed to just theoretically “legal” — must include removing mifepristone’s REMS program. Given the covid-19 pandemic, there has never been a more appropriate time.

A Risk Evaluation and Mitigation Strategy (REMS) is a set of restrictions that the Food and Drug Administration (FDA) can require for certain medications to decrease the risk of negative drug-related outcomes.[i] Examples of REMS and their “Elements to Assure Safe Use” (ETASU) include requiring health care providers who prescribe a certain drug to have specific training, or requiring that certain drugs be dispensed in designated health care settings — these can be seen in the table below, taken from the FDA’s website.[ii]

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As the FDA puts it, REMS are put in place to ensure that the “benefits of the medication outweigh the risks.” In general, there is no question that REMS as a primary prevention strategy are beneficial to the public’s health. However, if we look specifically at mifepristone — the first of two drugs used to induce a medication abortion — empirical data show us two key insights. First, the medication doesn’t require REMS to be taken safely and effectively. Second, due to the significant barriers in accessing medication abortion for millions of pregnant people in this country, the burden created by the medication’s REMS program significantly outweigh any potential benefit.

Medication abortion is a common, safe, and effective way to end a pregnancy up to 70 days (10 weeks) after the pregnant person’s last menstrual period (LMP). Since its approval by the FDA in 2000, medication abortion has grown increasingly popular; the most recent estimates show that approximately 60% of individuals who are ≤10 weeks pregnant choose to have a medication abortion (as opposed to an in-clinic procedure).[iii] The clinical “gold standard” for medication abortion involves taking 200 milligrams of mifepristone, which stops progesterone from going to the pregnancy, followed by 800 micrograms of misoprostol inserted buccally (inserted between the mouth’s cheek and gum to dissolve medication) or vaginally 24 to 48 hours later, thereby causing the uterus to contract and empty.[iv] Medication abortion is effective 95% of the time; when it is not effective, more medication or an in-clinic procedure is required to remove the pregnancy tissue.[v]

A systematic review which examined 47,000 women in 87 trials found the rate of serious complication, including hospitalization or blood transfusion, due to medication abortion to be 0.4%.[vi]; in contrast, the rate of significant complication due to cesarean section is 3.6%.[vii] The risk of dying from pregnancy in the United States (0.009%) is 14 times greater than the risk of dying from complications due to mifepristone (0.0063%).[viii] Leading medical organizations, such as the American Medical Association (AMA) and American College of Obstetricians and Gynecologists (ACOG), support lifting the mifepristone REMS.[ix],[x]

Mifepristone’s REMS consists of three parts: 1) the drug can only be dispensed in clinics, medical offices, and hospitals by or under the supervision of a certified prescriber; 2) health care providers who wish to prescribe the drug must become “certified” by completing and sending a form to the drug distributor; and 3) the patient must be given an FDA-approved medication guide and sign an patient agreement.[xi] As the Mifeprex REMS Study Group points out, the medication’s REMS provide no explanation as to how such restrictions decrease the risk of complication or infection.[xii] The passing of the pregnancy begins a few hours after taking misoprostol, which the patient takes in their own home — in the rare chance that a complication would occur, the patient wouldn’t be at the clinic regardless to receive care or be taken to the hospital.

The mifepristone REMS program is a health equity issue. Low-income people make up the majority of abortion patients in this country, and are disproportionately impacted by the cost of abortion care in comparison to their middle- and higher-income counterparts.[xiii],[xiv] There are costs that go into getting an abortion beyond the procedure or appointment itself, including missed days of work, transportation, gas, childcare, lodging, and food.[xv]

On the weekends, I work as a counselor at an independent abortion provider located outside of D.C. In comparison to our neighboring states to the west and south, Maryland has great access to abortion care. That said, certain regions of the state, including parts of western Maryland and the Eastern Shore, are located in “family planning deserts,” meaning there are no reproductive health care providers nearby. Each Saturday, I speak with people who’ve come from one or two hours away to access medication abortion care; they share with me the burden of finding a ride or childcare, paying for gas, or getting a $100 roundtrip Lyft on top of the costs of the medication. I also see plenty of people who share that they’re choosing to have the in-clinic procedure rather than doing medication abortion for the sole reason that they’re not required to come back to the clinic for a follow-up. If this is happening in the relatively small, progressive state of Maryland, I can only imagine the challenges faced by pregnant people seeking abortion care in large, predominantly anti-choice states. Removing the need to travel to the clinic for medication abortion would remove almost all of these barriers to care. It’s important that we remember that such sentiments about the barriers people had to overcome to get to the clinic are just from those who were ultimately able to make it to a clinic — we will never know the number of people across the country who wanted or tried to access abortion care but ultimately couldn’t do so due to any given number of obstacles.

On March 30th, 20 state attorney generals (AGs), including Maryland’s own AG Brian Frosh, signed onto the California AG Xavier Becerra’s letter to the FDA calling on them to waive Mifeprex’s REMS during the covid-19 pandemic.[xvi] While it’s nonsensical that the FDA wouldn’t waive the drug’s REMS when much of the country is facing stay-at-home orders, this is an issue which impacts pregnant people year-round, regardless of global catastrophes. This should be reflected in the next letter the AGs write to the FDA and U.S. Department of Health and Human Services (HHS).

The body of research on this issue has grown tremendously, and shown medication abortion to be safe and effective. Technology has advanced. And unfortunately, due to targeted regulations of abortion provider (TRAP) laws and gestation bans, clinics are closing and abortion access for many is getting fewer and farther in between. It is time to remove mifepristone’s REMS. Let us push the current FDA Commissioner and HHS Secretary to remove the restrictions — and if they don’t (which, let’s be honest, they likely won’t), we will force the next administration to listen to us, before, during, and after the 2020 November election.

Lastly, remember that our advocacy work will not be finished once the REMS are removed. Clinics and patients alike will require technical support. Billing processes must be in place to ensure that clinics are fairly compensated for telemedicine abortion care so that they don’t go out of business. State legislatures must pass laws to ensure that people cannot be wrongly prosecuted for pregnancy loss. People need to know where they can go if they need an in-person follow-up to ensure that no pregnancy tissue is left in the uterus. The good news is that, with hard work by progressive advocates and more pro-choice elected officials, all of this is possible.

[i] Food and Drug Administration (FDA). 2018. “Risk Evaluation and Mitigation Strategies.” August 8, 2019. https://www.fda.gov/drugs/drug-safety-and-availability/risk-evaluation-and-mitigation-strategies-rems

[ii] Food and Drug Administration (FDA). 2018. “What’s in a REMS?” January 26, 2018. https://www.fda.gov/drugs/risk-evaluation-and-mitigation-strategies-rems/whats-rems

[iii] Jones, Rachel, Elizabeth Witwer, and Jenna Jerman. 2019. “Abortion Incidence and Service Availability in the United States, 2017.” New York: Guttmacher Institute. https://www.guttmacher.org/report/abortion-incidence-service-availability-us-2017.

[iv] Cleland, Kelly, and Nicole Smith. n.d. “Aligning Mifepristone Regulation with Evidence: Driving Policy Change Using 15 Years of Excellent Safety Data.” Contraception 92: 127–81.

[v] Donovan, Megan. 2018. “Self-Managed Medication Abortion: Expanding the Available Options for U.S. Abortion Care.” Guttmacher Policy Review 21: 41–47.

[vi] Raymond, Elizabeth, Caitlin Shannon, Mark Weaver, and Beverly Winikoff. 2013. “First-Trimester Medical Abortion with Mifepristone 200 Mg and Misoprostol: A Systematic Review.” Contraception 87: 26–37.

[vii] Creanga, A. A., Bateman, B. T., Butwick, A. J., Raleigh, L., Maeda, A., Kuklina, E., & Callaghan, W. M. 2016. “Morbidity Associated With Cesarean Delivery in the United States.” Obstetric Anesthesia Digest, 36(3), 138.

[viii] Cleland, Kelly, Mitchell Creinin, Deborah Nucatola, Montsine Nshom, and James Trussell. 2013. “Significant Adverse Events and Outcomes After Medical Abortion.” Obstetrics & Gynecology 121 (1): 166–71.

[ix] American Medical Association (AMA), Ending the Risk Evaluation and Mitigation Strategy (REMS) policy on mifepristone (Mifeprex), Policy H-100.948, 2018, https://www.ama assn.org/sites/default/files/mediabrowser/public/hod/a18-resolutions.pdf.

[x] American College of Obstetricians and Gynecologists (ACOG), ACOG statement on medication abortion, news release, Washington, DC: ACOG, Mar. 30, 2016, https:// www.acog.org/About-ACOG/News-Room/Statements/2016/ ACOG-Statement-on-Medication-Abortion.

[xi] https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020687s020lbl.pdf

[xii] Mifeprex REMS Study Group. 2017. “Sixteen Years of Overregulation: Time to Unburden Mifeprex.” New England Journal of Medicine 376 (8): 790–94. https://doi.org/10.1056/NEJMsb1612526.

[xiii] Jerman J, Jones R, Onda T. Characteristics of U.S. Abortion Patients in 2014 and Changes Since 2008. Guttmacher Institute; 2016:1–28

[xiv] Dennis A, Manski R, Blanchard K. Does Medicaid Coverage Matter?: A Qualitative Multi-State Study of Abortion Affordability for Low-income Women. Journal of Health Care for the Poor and Underserved. 25(4):1571–1585. 2016.

[xv] Ostrach, B., & Cheyney, M. (2014). Navigating Social and Institutional Obstacles: Low-Income Women Seeking Abortion. Qualitative Health Research, 24(7), 1006–1017. https://doi.org/10.1177/1049732314540218

[xvi] Becerra, Xavier. 2020, March 30, 2020. https://ag.ny.gov/sites/default/files/final_ag_letter_hhs_medication_abortion_2020.pdf.

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