Due to the COVID-19 pandemic, the U.S. abortion industry has undergone significant changes. The Food and Drug Administration (FDA) regulates mifepristone, the more dangerous first drug of the two-part chemical abortion cocktail, via a Risk Evaluation and Mitigation Strategy (REMS), limiting how the drug can be dispensed. After years of fighting these safety standards,[1] the abortion industry took advantage of the pandemic to obtain a court order in July 2020 blocking the requirement that mifepristone be administered in person, a key element of the REMS. The Supreme Court stayed the court order[2] to allow time for the case to be appealed to the Fourth Circuit Court of Appeals, but in April 2021, the FDA officially suspended enforcement of the in-person requirement for the duration of the pandemic. Abortion providers are now permitted to send the abortion pill through the mail via a loosely regulated system of brick-and-mortar clinics, online pharmacies, video calls, and online evaluation forms.

 

The result is likely to be an increase in chemical abortions and chemical abortion complications.[3] Already, established online abortion pill distributors have expanded their footprints. The TelAbortion Project, a Gynuity-sponsored initiative to circumvent the REMS by means of a clinical trial, continues to add to its list of active states. Aid Access, a European-based organization that has illegally shipped mifepristone from a pharmacy in India, is now operating legally in states allowing telemedicine abortion, adding U.S. doctors to its network, and shipping pills from American pharmacies. However, Aid Access still uses its European network and Indian pharmacy for women in states where abortion by mail is not permitted. Other online abortion pill distributors have popped up, taking advantage of the permissive rules. Together, these distributors advertise that they ship abortion pills to 26 states.

 

Measuring the long-term impact of this regulatory change will be complicated. States have begun releasing 2020 abortion statistics showing dramatic increases in chemical abortions, and in some states, this has contributed to an increase in abortion rates overall. In general, though, the United States has poor abortion data due to little oversight and the resistance of statutory reporting requirements by abortion providers. One state health department has already informed the Charlotte Lozier Institute that they do not attempt to collect data from out-of-state providers who mail abortion pills to state residents. Even states with these requirements will likely find it difficult to track shipments from the new online distributors. Compounding the problem, less than a third of states have laws requiring hospitals and emergency departments to report abortion-related complications they treat.

 

However, better statistics in the United Kingdom offer a preview of what the U.S. can expect. In early 2020, the Department of Health and Social Care (DHSC), which oversees healthcare in the U.K., made a very similar rule change to allow abortion drugs to be taken at home.[4] This change had the effect of allowing mifepristone to be dispensed through the mail, termed “pills-by-post” by the abortion industry. Chemical abortions made up 72% of all abortions in January-June 2019.[5] In January-June 2020, they composed 82%. Total abortions increased from 105,540 resident abortions from January-June 2019 to 109,836 in January-June 2020.

 

This change was celebrated as convenient and safe, with only one reported complication in over 23,000 at-home abortions. Unfortunately, DHSC's only source of complication data is the abortion reporting forms submitted by abortion providers. It appears that these forms can be submitted when the pills are mailed out before the woman has even received them. A former director and consultant of abortion chain Marie Stopes International (MSI), set out to determine the true incidence of chemical abortion complications. He and his research team submitted a series of freedom of information (FOI) requests to the United Kingdom's healthcare system.[6]

 

One FOI request went to the Care Quality Commission, a branch of the DHSC that regulates health services. The Care Quality Commission had records of 29 serious incidents resulting from chemical abortion between April and November 2020. Seventeen of these very serious complications were caused by pills-by-post, including 11 cases in which the woman went to the hospital after taking the pills beyond the legal gestational limit. The researchers also submitted FOI requests to Ambulance Service NHS Trusts. Although they were unable to determine how many emergencies resulted from pills-by-post, between 2019 and 2020, emergency calls for chemical abortion increased 54% when extrapolated across England and Wales, and ambulance responses rose by 19%. FOI requests to NHS Hospital Trusts predict that every month on average, 340 women using pills-by-post will end up in the hospital with an incomplete abortion, and 250 will require surgical treatment; the average rate of surgical intervention is 2.4 procedures per 100 abortions. Some women suffered hemorrhage or sepsis as a result of chemical abortion. In six hospitals that provided data, this resulted in a complication rate five times higher than the official rate reported by the DHSC in 2019 and 2020.

 

Additionally, researchers conducted a mystery client investigation of the pills-by-post process. [7] They discovered that the abortion clinics were unable to confirm the woman's identity over the phone or make sure that she was the person who actually would be taking the pills. They could not ensure that she was free of coercion from an abusive partner, and they could not verify her pregnancy: the mystery callers were prescribed the pills even though they were not pregnant. The abortion clinics were unable to confirm gestational age; in fact, they allowed the mystery callers to change the stated date of their last period to fall within the legal gestational limit.

 

These same risks are present in the United States. Even before the FDA waived the in-person requirement, there were multiple instances in which abusive partners were able to obtain abortion pills and administer them to women without their knowledge and consent.[8] An analysis of complication data collected by the FDA revealed lax oversight and significant risks from mifepristone, problems which will only worsen with loosened restrictions.[9] The FDA’s suspension of the in-person requirement is supposed to be temporary, slated to expire when the COVID-19 public health emergency ends. However, FDA has signaled that it may be making the changes permanent.[10]

 

Fortunately, some states already have laws in place that prevent mifepristone from being distributed via telemedicine.[11] A few states have begun moving beyond their initial protections and formally establishing the safeguards the FDA abandoned. These new laws ensure that no woman is administered mifepristone without receiving a complete medical examination to rule out dangerous conditions like ectopic pregnancy or advanced gestational age. When in-person visits are required, the abortion providers can make sure that each woman is alone and able to confide with her doctor whether she is being abused or coerced into having an abortion. The laws also provide women with critical information about abortion pill reversal should she change her mind after taking the abortion pill and decide to save the life of her baby.

 

Without strong leadership from the federal government, women and unborn babies in states without chemical abortion regulations, including high-volume abortion states like California, New York, and Illinois, will continue to be at risk. Still, state-level chemical abortion regulations are a good first step. As the FDA abdicates its role as the protector of women's health, and national abortion data continues to worsen, state laws will have an increasing impact on chemical abortion in the United States.

 

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[1] Longbons, T. (2019). The push to expand chemical abortion in the United States. Sebastian’s Point.

[2] See https://www.supremecourt.gov/opinions/20pdf/20a34_3f14.pdf.

[3] See Charlotte Lozier Institute (2021). CLI fact sheet: an abundance of neglect.

[4] See The Abortion Act 1967 – Approval of a Class of Places

[5] See Abortion statistics for England and Wales during the COVID-19 pandemic

[6] See FOI investigation into complications from abortion at home.

[7] See Mystery Client Investigation

[8] Howard, H. (2020). Medical and social risks associated with the unmitigated distribution of mifepristone: a primer. Charlotte Lozier Institute.

[9] Aultman, K.A., Cirucci, C.A., Harrison, D.J., Beran, B.D., Lockwood, M.D., Sieler, S. (2021). Deaths and severe adverse outcomes after the use of mifepristone as an abortifacient from September 2000 to February 2019. Issues in Law & Medicine.

[10] See Bloomberg (2021). Hawaii abortion pill in-person rule fight paused for FDA review

[11] See Guttmacher Institute (2021). Medication abortion

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