Author Archives: Riley Driscoll

Are Abortion Pill In-Person Requirements During COVID-19 Unduly Burdensome? SCOTUS Says No.

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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In the Shadow of the COVID-19 Pandemic, A Looming Mental Health Crisis

As most Americans fixate on the surging COVID-19 cases and deaths, health care experts are growing weary of “an imminent mental health surge” in the United States. Over the past nine months, COVID-19 has affected Americans of all ages in every facet of daily life disrupting employment, education, religious practices, recreational activities and relationships. The staggering amount of death experienced in the nine months since the World Health Organization declared the virus a pandemic is devastating. In the United States, the number of deaths currently attributed to COVID-19 is nearly 4 times the deaths of Americans killed during the entirety of the Vietnam War which spanned two decades. This magnitude of death combined with an upheaval of normal grieving processes due to social distancing measures has significantly altered the ways in which individuals and families cope with grief, compounding their already disrupted daily lives. 

A recent study, conducted this year by scientists at the Journal of Affective Disorders, showed a global increase in the prevalence and severity of anxiety and depression and increases in post-traumatic stress disorder and substance abuse. Of central concern is the transformation of normal grief and distress into prolonged grief and major depressive order and symptoms of post-traumatic stress disorder. Indicators of prolonged grief disorder include at least six months of intense longing, preoccupation, or both with the deceased, emotional pain, loneliness, difficulty reengaging in life, avoidance, feeling life is meaningless, and increased suicide risk. These conditions, once established, could become chronic and may lead to substance use disorders. While prolonged grief affects approximately 10% of bereaved individuals, experts believe is an underestimate for grief related to deaths from COVID-19. Measurements estimate that each COVID-19 death leaves an estimated nine family members bereaved. This approximation projects over two million bereaved individuals at the current COVID-19 death count. Mental health experts warn this level of  bereavement, triggering new mental health disorders and intensifying existing mental health disorders, has the potential to overwhelm the American healthcare system beyond its capacity. 

America’s infrastructure for mental health and addiction services was fragmented, overburdened, and underfunded even before the COVID-19 crisis. An online survey of 880 organizations that provide behavioral-health services revealed that the pandemic has forced practices to reduce services, provide care to patients without sufficient protective equipment, lay off and furlough employees, and risk untimely closures. This reduction in services further burdens individuals with serious mental illness from receiving treatment and/or medication for their conditions, including those who are experiencing such symptoms for the first time. Alarmingly, mirroring COVID-19 itself, experts anticipate that a mental health surge will disproportionately affect Black and Hispanic individuals, older individuals, lower socio-economic groups of all races and ethnicities, and health care workers. 

Each day, as the United States continues to report record breaking COVID-19 cases, mental health care experts are certain the second wave of the COVID-19 pandemic is imminent. Experts suggest immediate emergent funding for mental health programs; widespread screening to identify those at the highest risk; availability of primary care clinicians and mental health professionals trained to treat those with prolonged grief, depression, traumatic stress, and substance abuse; and a diligent focus on families and communities to creatively restore the approaches by which they have managed tragedy and loss over generations. To further mitigate the threats of a mental health care disaster, states like Connecticut, are reaching out to the Centers for Disease Control and Prevention for grants to support expanded mental health resources after experiencing increases in both the use of the state’s suicide hotline and suicide rate amid the COVID-19 pandemic. 

Even as mental health care experts rush to mitigate the potential devastation of a second wave, it is clear that the havoc from COVID-19 will be felt for generations to come. The tremendous loss of life and the disruptions to all aspects of everyone’s lives reminds us of our fragility and how important it is and it will be to provide adequate mental health protections as an integral part of the healing process.

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