Medication abortion, commonly referred to as the abortion pill, is a safe and effective way to terminate an early pregnancy and has been available in the United States for the past 20 years. The abortion pill is as safe and effective as the surgical procedure, but it can be administered in the comfort of one’s home. Abortion via medication requires the patient take two different drugs: mifepristone and misoprostol. Mifepristone is taken first and blocks the body’s progesterone and stops the pregnancy from progressing. Next, Misoprostol causes the uterus to empty. Individuals can obtain and use the abortion pill up to 77 days or 11 weeks after the date of their last period, although the effectiveness depends on how far along they are into their pregnancy.
The FDA first approved mifepristone in 2000. Mifepristone is a synthetic steroid that is also used to treat hyperglycemia in patients with Cushing’s syndrome. In the United States, the use of mifepristone for abortion is highly regulated by the FDA through a set of rules known as the risk evaluation and mitigation strategy (REMS), despite evidence of its safety and efficacy. Among other restrictions, the REMS limits the distribution settings of mifepristone, not misoprostol, to clinics, medical offices, and hospitals, by or under the supervision of a certified prescriber. This is referred to as the in-person requirement. Mifepristone, when used to end pregnancy, is the only FDA-approved drug required to be dispensed in clinical settings while permitting patients to self-administer at home. Furthermore, the FDA permits patients taking mifepristone for reasons other than abortion to receive the drug through the mail in much higher doses and quantities.
On January 31, 2020, the Secretary of Health and Human services declared a public health emergency pursuant to the Public Health Service Act. Subsequent regulatory guidance focused on allowing patients to access healthcare they need from their home, without worrying about putting themselves or others at risk during the COVID-19 outbreak. This included waivers in recognition of the health risks associated with patient travel to medical facilities, even invoking the use of the “telemedicine exception” in the Controlled Substances Act, which permits practitioners to forgo an in-person evaluation of a patient before prescribing certain controlled substances, including opioids, permitting them instead to rely on telemedicine to assess a patient before issuing a prescription. In response to this flurry of telehealth exceptions, abortion providers challenged the in-person requirement still restricting mifepristone. The US District Court for the District of Maryland granted a preliminary injunction enjoining the FDA from enforcing, threating to enforce, or otherwise applying the in-person requirements for Mifepristone.
On January 12, 2021, the Supreme Court issued a brief and unsigned opinion that overturned the District Court’s decision and reinstated the federal requirement that women seeking to end their pregnancies using the abortion pill pick up their medications in person. Chief Justice Roberts, the only member of the majority to write an opinion, explained that this case was decided on judicial deference and allowed the FDA experts to use their statutorily provided discretion. According to Chief Justice Roberts, the issue was not whether the regulation placed an undue burden on women seeking abortions during the COVID-19 pandemic but whether the District Court properly enjoined the FDA from enforcing the in-person requirement. Despite the Court’s insistence that the issue presented did not concern the in-person restriction itself, the effects of this ruling on women seeking abortions is catastrophic.
Due to the vastly limited clinic options and already tight window for obtaining an abortion pill prescription, the FDA’s in-person requirement for Mifepristone places an unnecessary and undue burden on the right to abortion as established in Planned Parenthood v. Casey. In her dissenting opinion, Justice Sotomayor stated that this ruling “singles out abortion for more onerous treatment than other medical procedures that carry similar or greater risks” and “it imposes an unnecessary, irrational and unjustifiable undue burden on women seeking to exercise their right to choose.” The Supreme Court’s ruling brings into question what qualifies as an undue burden under the current judicial framework, and if any obstacle will prevail in arguments before the current majority.
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