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Substantial Obstacles after June Medical Services: ACOG v. FDA

By Rachel Rebouché

In June Medical Services v. Russo, the Supreme Court held that a Louisiana law requiring that physicians obtain admitting privileges at a nearby hospital was unconstitutional. Had the law taken effect, all but one provider would have lost the ability to deliver abortion care in the state. Despite the result, a number of commentators have expressed concern about the future of abortion rights. The source of their concerns is the Chief Justice’s application of the undue burden test—the standard for judging the constitutionality of an abortion restriction—established in Planned Parenthood v. Casey.

Justice Breyer, who wrote the judgment of the Court in June Medical Services, balanced the benefits and burdens conferred by the law, finding that the statute offered no benefit for people’s health and created significant burdens on the delivery of abortion. The admitting-privileges requirement does not protect patients’ safety because complications from abortion are rare and thus rarely will a patient need admission to a hospital. Moreover, admitting privileges, which the district court found each provider had pursued in good faith, do not determine a physician’s competency or credentials.

Although Chief Justice Roberts’s concurrence provided the fifth vote to strike down the law, Roberts wrote separately to emphasize that whether the Louisiana law had any identifiable benefit for patients was immaterial. The Court need only address what burdens the law imposed—if a law establishes “significant obstacles” to abortion. Roberts’s concurrence clearly departs from Breyer’s approach of weighing the law’s benefits against its burdens. Breyer’s formulation would render a law unconstitutional if it had no health benefits but erected a minimal obstacle to abortion care. Roberts’s approach would not: a law only fails the undue burden test—no matter how unsuccessful legislation is in achieving its purported goals—if the restriction renders abortion access substantially more difficult.

How Roberts’s interpretation of the undue burden test applies may soon become clear. Consider a case decided recently by the U.S. District Court of the District of Maryland, American College of Obstetricians & Gynecologists et al. v. United States Food and Drug Administration et al. ACOG challenged the constitutionality of the FDA’s restrictions on Mifeprex (or mifepristone), the first drug ingested in a medication abortion.

The FDA applies a drug safety program to Mifeprex (a Risk Evaluation and Mitigation Strategy, or REMS), which mandates, among other things, collection of mifepristone at a clinic, physician’s office, medical center, or hospital. ACOG argued that the REMS restriction contradicts substantial evidence of the drug’s safety. Moreover, of the 20,000 drugs regulated by the FDA, Mifeprex is the only one that patients must retrieve at a medical center but may self-administer without supervision. In fact, the FDA permits mailing the same compound, when not prescribed for abortion or miscarriage, to patients’ homes in higher doses and larger quantities. The effect of the REMS classification is that medication abortion cannot be mailed, excluding the possibility of telehealth for abortion. The FDA’s enforcement of the in-person requirement for mifepristone stands in stark contrast to the numerous ways the FDA (as well as other federal agencies) have encouraged telemedicine as a response to the pandemic.

Last week, Judge Chuang issued a nationwide injunction of the REMS protocol, as applied to Mifeprex, for the duration of COVID-19 national emergency. Though there is much to analyze about the decision’s reasoning, two points are worth highlighting. First, Judge Chuang rejected Roberts’s version of the undue burden test, weighing the benefits and burdens of FDA policy. Second, Judge Chuang’s decision details the cumulative effects of abortion restrictions based on expert testimony and public health research—that the “combination of such barriers can establish a substantial obstacle.”

The court took care to develop the factual case for suspending the REMS restriction. Judge Chuang cited evidence of how the in-person requirement exacerbates the burdens already felt by those who work essential jobs or are unemployed, have lost health insurance, live in multi-generational homes, and lack transportation. He highlighted that low-income patients and people of color suffer disproportionately; they are more likely to become ill, to have inadequate resources to respond to illness, and will have worse health outcomes as a result deep health inequalities. Mirroring the logistical challenges most abortion patients face, the pandemic makes arranging for childcare, transport, or time off work especially difficult.

The district court’s decision will be appealed, and it may come before the Supreme Court, depending on how long the national emergency lasts. If the case comes before the Court, Roberts’s formulation of the undue burden test may suggest that none of the plaintiffs’ arguments matter: even if FDA restrictions are untethered to medication abortion’s safety, they may not necessarily produce the type of obstacle at issue in June Medical Services—the in-person requirement forced no clinic to close, although it has strained providers’ time, and logistical impediments to abortion preceded and will continue after the pandemic.

Yet, of significance, Judge Chuang’s resistance to the Roberts’s concurrence may provide a roadmap for other courts deciding the constitutionality of abortion restrictions. The decision also demonstrates a nuanced understanding of the importance of a lower court’s record in determining what are substantial obstacles.

 

Rachel Rebouché is an Associate Dean for Research and James E. Beasley Professor of Law at Temple University Beasley School of Law.

The Petrie-Flom Center Staff

The Petrie-Flom Center Staff

The Petrie-Flom Center staff often posts updates, announcements, and guests posts on behalf of others.

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