Expert Commentary

Lifting the restrictions on mifepristone during COVID-19: A step in the right direction

OBG Manag. December 2020;32(12):13-14, 23, 38. Published online first September 10, 2020 | doi: 10.12788/obgm.0034

References

American College of Obstetricians and Gynecologists. Practice bulletin number 143: medical management of first trimester abortion. Obstet Gynecol. 2014;123:676-692.
Schreiber CA, Crenin MD, Atrio J, et al. Mifepristone pretreatment for the medical management of early pregnancy loss. N Engl J Med. 2018;378:2161-2170.
Danco Laboratories. Mifeprex effectiveness and advantages. https://www.earlyoptionpill.com/is-mifeprex-right-for-me/effectiveness-advantages/ Accessed August 2, 2020.
Jones RK, Witwer E, Jerman J. Abortion incidence and service availability in the United States, 2017. September 2019. https://www.guttmacher.org/report/abortion-incidence-service-availability-us-2017. Accessed September 10, 2020.
American College of Obstetricians and Gynecologists. Practice bulletin no. 150: early pregnancy loss. Obstet Gynecol. 2015;125:1258-1267.
US Food and Drug Administration. Risk evaluation and mitigation strategy (REMS) single shared system for mifepristone 200 mg. April 2019. https://www.accessdata.fda.gov/drugsatfda_docs/rems/Mifepristone_2019_04_11_REMS_Full.pdf. Accessed September 10, 2020.
US Food and Drug Administration; Center for Drug Evaluation and Research. 2016 REMS Review, Summary Review 25. March 29, 2016. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/020687Orig1s020SumR.pdf. Accessed September 10, 2020.
American College of Obstetricians and Gynecologists. Improving access to mifepristone for reproductive health indications. June 2018. https://www.acog.org/clinical-information/policy-and-position-statements/position-statements/2018/improving-access-to-mifepristone-for-reproductive-health-indications. Accessed August 2, 2020.
US Food and Drug Administration. Policy for certain REMS requirements during the COVID-19 public health emergency: guidance for industry and health care professionals. March 2020. https://www.fda.gov/media/136317/download. Accessed September 10, 2020.
US Department of Justice. US Drug Enforcement Administration. COVID-19 Information Page, Telemedicine. https://www.deadiversion.usdoj.gov/coronavirus.html#TELE. Accessed May 25, 2020.
Centers for Disease Control and Prevention. Coronavirus disease 2019: health equity considerations and racial and ethnic minority groups. https://www.cdc.gov/coronavirus/2019-ncov/community/health-equity/race-ethnicity.html. Updated July 24, 2020. Accessed September 10, 2020.

REMS changes during the COVID-19 pandemic

The coronavirus disease 2019 (COVID-19) pandemic has necessarily changed the structure of REMS and ETASU requirements for many medications, with changes made in order to mitigate viral transmission through the limitation of unnecessary visits to clinics or hospitals. The FDA announced in March of 2020 that it would not enforce pre-prescription requirements, such as laboratory or magnetic resonance imaging results, for many medications (including those more toxic than mifepristone), and that it would lift the requirement for in-person dispensation of several medications.⁹ Also in March 2020 the Department of Health and Human Services Secretary (HHS) and the Drug Enforcement Agency (DEA) activated a “telemedicine exception” to allow physicians to use telemedicine to satisfy mandatory requirements for prescribing controlled substances, including opioids.¹⁰

Despite repeated pleas from organizations, individuals, and physician groups, the FDA continued to enforce the REMS/ETASU for mifepristone as the pandemic decimated communities. Importantly, the pandemic has not had an equal effect on all communities, and the disparities highlighted in outcomes as related to COVID-19 are also reflected in disparities to access to reproductive choices.¹¹ By enforcing REMS/ETASU for mifepristone during a global pandemic, the FDA has placed additional burden on women and people who menstruate. As offices and clinics have closed, and as many jobs have evaporated, additional barriers have emerged, such as lack of childcare, fewer transportation options, and decreased clinic appointments.

As the pandemic continues to affect communities in the United States, ACOG has issued guidance recommending assessment for eligibility for medical abortion remotely, and has encouraged the use of telemedicine and other remote interactions for its members and patients to limit transmission of the virus.

The lawsuit

On May 27, 2020, the American Civil Liberties Union (ACLU) (on behalf of ACOG, the Council of University Chairs of Obstetrics and Gynecology, New York State Academy of Family Physicians, SisterSong, and Honor MacNaughton, MD) filed a civil action against the FDA and HHS challenging the requirement for in-person dispensing of mifepristone and associated ETASU requirements during the COVID-19 pandemic. The plaintiffs sought this injunction based on the claim that these restrictions during the pandemic infringe on the constitutional rights to patients’ privacy and liberty and to equal protection of the law as protected by the Due Process Clause of the Fifth Amendment. Additionally, the ACLU and other organizations said these unnecessary restrictions place patients, providers, and staff at unnecessary risk of viral exposure amidst a global pandemic.

The verdict

On July 13, 2020, a federal court granted the preliminary injunction to suspend FDA’s enforcement of the in-person requirements of mifepristone for abortion during the COVID-19 pandemic. The court denied the motion for suspension of in-person restrictions as applied to miscarriage management. The preliminary injunction applies nationwide without geographic limitation. It will remain in effect until the end of the litigation or for 30 days following the expiration of the public health emergency.

What the outcome means

This injunction is a step in the right direction for patients and providers to allow for autonomy and clinical practice guided by clinician expertise. However, this ruling remains narrow. Patients must be counseled about mifepristone via telemedicine and sign a Patient Agreement Form, which must be returned electronically or by mail. Patients must receive a copy of the mifepristone medication guide, and dispensing of mifepristone must still be conducted by or under the supervision of a certified provider. The medication may not be dispensed by retail pharmacies, thus requiring providers to arrange for mailing of prescriptions to patients. Given state-based legal statutes regarding mailing of medications, this injunction may not lead to an immediate increase in access to care. In addition, patients seeking management for miscarriage must go to clinic to have mifepristone dispensed and thus risk exposure to viral transmission.