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Reproductive Health During COVID: Eliminating FDA’s Burdensome Barriers to Mifepristone

What is Mifepristone? 

Mifepristone is the primary component in the FDA-approved regimen taken to terminate pregnancies through 10 weeks gestation and is seen as an alternative to a surgical procedure.1 Many patients view this as less invasive, allowing for more privacy and control over a personal situation. The standard oral regimen includes mifepristone 200mg followed by misoprostol 800mcg 24-48 hours later. There are alternative doses available depending on medication availability and gestational window.2 mifepristone and misoprostol work in tandem to halt the pregnancy from developing and induce cramping to evacuate the contents of the uterus. Following the administration of these medications, women typically report back to their healthcare provider one to two weeks later to ensure the medications were fully effective and that the pregnancy has been terminated. Women can expect heavy bleeding and strong abdominal cramps that are most severe during the first few hours post-treatment but typically subside over the next day or two.1,3

Current Practice of Mifepristone Prescribing

The protocol for women pursuing medication abortion counseling and treatment often begins in a doctor’s office. Patients undergo a series of health screenings including laboratory testing, an ultrasound assessment to determine gestational age, and contraindication evaluations.2,4 

Additionally, the FDA requires a Risk Evaluation and Mitigation Strategy (REMS) prior to prescribing mifepristone, stating this is necessary to ensure safe use of the medication by patients.1,4 REMS programs are typically employed when prescribing medications with major safety concerns or the potential for serious adverse effects. Beyond this program, there are numerous stipulations to prescribing and dispensing mifepristone. Patient agreement forms, healthcare provider supervision and policies that restrict dispensing this medication anywhere outside of clinics, medical offices, and hospitals, make mifepristone unnecessarily difficult for patients to obtain.

How Has the Pandemic Impacted this Process? 

Cue the COVID-19 pandemic and reproductive health becomes infinitely harder. Once the country began shutting down in March, schools, businesses, and many other public entities were at a standstill as nonessential services. While many healthcare facilities were faced with overwhelming numbers of potential patients with coronavirus, other health related surgeries and appointments were postponed to mitigate infection risk in the general population. Access to abortion is time-sensitive, so when it is unavailable it leaves many women without fundamental choices for their family planning and reproductive outcomes. 

Reproductive care, including abortion, has been regarded as nonessential in many states across the United States, barring women from access to vital medical services. Governors in Texas, Louisiana, Mississippi, Alabama, and Oklahoma have made efforts towards ending both medical and surgical abortions.5 These states, among others, have aimed to restrict access to reproductive health processes by deeming them elective rather than essential procedures. As of April 8th 2020, Temporary Restraining Orders (TROs) have impeded certain state bans on abortions while litigation remains ongoing in Ohio, Alabama, and Oklahoma.5 While certain states continue to debate reproductive health legislation, congressional lawmakers contested the FDA on behalf of their constituents earlier this month. On June 16th 2020, the FDA received a letter on behalf of over 100 members of congress urging them to ease restrictions surrounding reproductive care during the pandemic.6 

ACOG’s Efforts to Ease Reproductive Care Restrictions 

In response to certain states’ stringent limitations and the overdue revisions to modern reproductive care, the American College of Obstetricians and Gynecologists (ACOG) filed a lawsuit petitioning the FDA to remove restrictive barriers to obtaining mifepristone during the COVID pandemic. The civil rights action was officially filed May 27th, 2020 to challenge the FDA to alter the multitude of requirements to prescribing mifepristone as nationwide efforts shift towards telemedicine.7,8 Both the CDC and the FDA have encouraged the use of telehealth to allow flexibility for doctors to safely meet with their patients while foregoing unnecessary in-person appointments. Thus far, women seeking mifepristone to end an early pregnancy or manage a miscarriage have been an exception to the highly enforced transition to telemedicine.7 Likewise, women are still required to travel to their doctor’s medical office or hospital to pick up the medication rather than a contactless option like mail order. ACOG pointed out the incongruence of the FDA’s standards which require patients to be seen in person to obtain mifepristone, yet allows them to take it in their homes without medical supervision. To emphasize their point, ACOG continues by noting that out of more than 20,000 drugs regulated by the FDA, mifepristone is the only medication that has such specifications, while allowing patients to self-administer in a location of their choosing.7 

When utilized for reasons other than abortion or miscarriage, the FDA allows mailing mifepristone to patients’ homes without the barriers imposed upon women pursuing reproductive care.7 This caveat exclusively hinders women in need of reproductive care from easily obtaining the required medications without bearing the unnecessary risk of COVID-19 infection from visiting a medical clinic. Many women who refuse this option are left with less effective options which may necessitate consequential procedures, thereby increasing exposure risk for patients and healthcare workers; the very circumstance all facets of medicine are trying to avoid.7

Recent Updates to Gaining Mifepristone Access

After deliberation in federal court, ACOG accomplished what they sought out to do when issuing their lawsuit to the FDA. On July 13th 2020,  a federal district court ruled in favor of a temporary suspension of the restrictions imposed upon obtaining mifepristone.9 The ruling sided with the notion that the barriers around  mifepristone subjected countless women to the unnecessary health risks of public exposure during the COVID-19 pandemic. While the preliminary qualifications and REMS testing still applies, the court’s order allows clinicians to mail mifepristone to eligible patients seeking abortion care under the U.S. Department of Health and Human Services’ COVID-19 Public Health Emergency. Although this has the potential to vastly expand access to mifepristone, ACOG continues to encourage clinicians to practice within their state’s laws which take precedence over this ruling.10 In response to the lifted restrictions, the president of ACOG, Eva Chalas, M.D., FACOG, FACS, hailed this decision as a “necessary step forward in our collective work toward health equity”.9  

How Pharmacists Can Play a Role

As the nation strives to adapt to telemedicine, pharmacists are becoming the sole in-person healthcare provider for many Americans. Pharmacists are often conveniently positioned in stores housing groceries or necessary supplies that people continued visiting during the pandemic. As one of few essential businesses that never closed, pharmacy dispensing of mifepristone would enable women to have more timely access to mifepristone and avoid the added risks of visiting additional clinic locations. In light of telemedicine, health disparities would be reduced for patients that have difficulty accessing medical abortions in their communities. Pharmacists may be able to help fill this gap and ensure safe use of mifepristone by counseling patients on how to take it and by answering questions that may arise.4 This shift in responsibility would continue to prioritize patient safety while employing trained healthcare professionals to aid in convenience, education and accessibility to a time-sensitive medication. 

References

  1. Center for Drug Evaluation and Research. (n.d.). Mifeprex (mifepristone) Information. Retrieved June 24, 2020, (link)
  2. (n.d.). Retrieved June 27, 2020, from (link)
  3. Center for Drug Evaluation and Research. (n.d.). Questions and Answers on Mifeprex. Retrieved June 24, 2020, (link)
  4. Raifman, S., Orlando, M., Rafie, S., & Grossman, D. (2018). Medication abortion: Potential for improved patient access through pharmacies. Journal of the American Pharmacists Association, 58(4), 377-381. doi:10.1016/j.japh.2018.04.011
  5. Bayefsky, M. J., Bartz, D., & Watson, K. L. (2020). Abortion during the Covid-19 Pandemic — Ensuring Access to an Essential Health Service. New England Journal of Medicine, 382(19). doi:10.1056/nejmp2008006
  6. Congress of the United States – degette.house.gov. (2020, June 16). Retrieved June 24, 2020, from (link)
  7. ACOG V. FDA Complaint Mifepristone COVID-19, retrieved June 24, 2020 (link).
  8. ACOG Suit Petitions Court to Remove FDA’s Burdensome Barriers to Reproductive Care During COVID-19. (2020, May 27). Retrieved June 24, 2020 (link)
  9. Federal Court Blocks FDA Restriction That Unnecessarily Imposes COVID-19 Risks on Patients Seeking Abortion Care. 27 May 2020, (link)
  10. “Court’s Order Lifting Burdensome FDA Restriction: What You Need to Know.” ACOG, 15 July 2020, www.acog.org/news/news-articles/2020/07/courts-order-lifting-burdensome-fda-restriction-what-you-need-to-know.

About the Author

Savannah Gross, PharmD Candidate, is a third-year pharmacy student at University of Georgia College of Pharmacy

Article Reviewed by: Sally Rafie, PharmD, BCPS, APH, NCMP, FCCP

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