Justices grant FDA request to block mail delivery of abortion pills

The Supreme Court on Tuesday granted a request from the Food and Drug Administration to reinstate a federal requirement that a pill used to induce abortion in the early stages of pregnancy be picked up in person from a health care provider. A federal district judge had suspended that requirement last summer because of the COVID-19 pandemic and then left that ruling in place after the justices in October directed the FDA to return to the lower court to seek narrower relief.

The Supreme Court’s new order means that the FDA will once again be able to enforce the regulations requiring in-person visits, although its willingness to do so could change once the administration of President-elect Joe Biden takes over next week. The justices divided on ideological lines in the ruling in Food and Drug Administration v. American College of Obstetricians and Gynecologists, with the court’s three liberal justices indicating that they would have denied the administration’s application.

The regulations at the center of Tuesday’s order control the dispensation of mifepristone, a drug that the FDA has approved to end pregnancies through the first 10 weeks. Under the FDA’s regulations, patients who want to use the drug to terminate their pregnancies must sign a form acknowledging risks associated with the drug and receive the pill, which is often produced under the brand name Mifeprex, from a health care provider in a medical setting. Once they have picked up the drug from a hospital or clinic, patients can take the pill at home, but they cannot receive the pill through the mail.

The American College of Obstetricians and Gynecologists went to federal court in Maryland last year, arguing that requiring patients to visit their health care providers in person in the middle of a pandemic violates the Constitution by creating a substantial obstacle to receiving an abortion. U.S. District Court Judge Theodore Chuang agreed with ACOG and issued an order in July that prohibited the FDA from enforcing the in-person requirement anywhere in the United States until the pandemic is over.

After the U.S. Court of Appeals for the 4th Circuit rejected the FDA’s request to put Chuang’s ruling on hold while the FDA appealed, the FDA went to the Supreme Court on Aug. 26. But the justices did not act until Oct. 8, when they issued a one-paragraph order that declined to resolve the FDA’s request. The FDA had argued, the court explained, that Chuang’s order was – at a minimum – too sweeping, because it applied to all 50 states, regardless of COVID-19 rates in particular states. Reasoning that more information would assist them, the justices indicated that the FDA should go back to the district court to ask Chuang to lift, modify or freeze his order, “including on the ground that relevant circumstances have changed.” Chuang, the court also made clear, “should rule within 40 days of receiving the Government’s submission.”

On Dec. 9, Chuang issued a new order that denied the FDA’s request to stay or dissolve his earlier order. Emphasizing that his order blocking the FDA from enforcing the in-person requirement is “not open-ended,” particularly in light of “the positive news relating to vaccines,” Chuang concluded that at this “most deadly phase of the pandemic” the FDA had not shown that circumstances had not improved enough to warrant any changes to his July order.

The FDA returned to the Supreme Court on Dec. 15, arguing – as it had in its original filing – that enforcing the regulations does not impose a substantial obstacle on a woman’s ability to obtain an abortion. Patients can always obtain a surgical abortion, it noted. Moreover, the FDA added, two states – Indiana and Nebraska – independently require patients to pick up the pill in person from their health care providers. The number of abortions in those states has in fact gone up during the pandemic, the FDA pointed out, refuting any idea that requiring in-person visits would make it harder to obtain an abortion.

In its response, ACOG emphasized that patients “were already free to have their evaluation and counseling done via telemedicine and to swallow the mifepristone tablet at the time and place of their choice.” By prohibiting the FDA from requiring an in-person visit to actually pick up the pill, the district court’s order helps to “avert[] serious viral risks.” And although the district court’s order had been in effect for nearly six months, ACOG wrote, the FDA had not provided any evidence that anyone had been harmed by being able to obtain mifepristone without an in-person visit. Finally, ACOG concluded, although the Supreme Court “might have hoped that the pandemic was easing” in October, when it sent the case back to the district court for another look, the opposite has been true. “There is even less basis to support a stay today than there was in October, when this Court initially declined to grant one,” ACOG asserted.

In a brief order issued late Tuesday afternoon, nearly a month after the Trump administration filed its reply brief in support of its request, the court granted the request. The court’s ruling allows the FDA to enforce the in-person rule while it continues its appeal of Chuang’s order on the merits.

Chief Justice John Roberts wrote a separate opinion agreeing with the decision to put Chuang’s order on hold and allow the FDA to enforce the in-person requirement pending appeal. Roberts emphasized that the question for the justices at this juncture was not whether the in-person requirement makes it harder for women to obtain abortions. Instead, he stressed, the question was whether Chuang was correct in ordering the FDA to lift the in-person requirement based on his “own evaluation of the impact of the COVID-19 pandemic.” Reiterating his view that, in the context of the pandemic, courts should generally not second-guess the “the politically accountable entities with the ‘background, competence, and expertise to assess public health,’” Roberts concluded that Chuang should not have ordered the FDA to relax the in-person requirement.

Justice Stephen Breyer indicated that he would deny the FDA’s application. He did not join the separate dissent by Justice Sonia Sotomayor, which Justice Elena Kagan did join. Because of the pandemic, Sotomayor observed, the Centers for Disease Control has generally urged health-care providers to use telemedicine for appointments whenever possible, but the government has refused to do so for women seeking medication abortions. Moreover, Sotomayor added, the pandemic has become worse since October, when the FDA first asked the government to reinstate the in-person requirement.

Turning to the heart of the FDA’s request, Sotomayor contended that enforcement of the in-person requirement “places an unnecessary and undue burden” on a woman’s right to obtain an abortion. Women seeking an abortion are already at risk of complications from COVID, Sotomayor explained, because they are pregnant and because they are more likely to be women of color and have low incomes; the difficulties of obtaining an abortion become even greater, she added, because “medical offices have dramatically reduced availability during the pandemic.” As a result, she explained, the district court “found that these obstacles can cause women to miss the 10-week window for a medication abortion altogether.”

Sotomayor was sharply critical of the FDA’s suggestion that even if women are unable to obtain a medication abortion in a timely manner, they can still obtain a surgical abortion. “What a callous response,” Sotomayor retorted. Surgical abortions “are far more invasive” and riskier than medication abortions.

Addressing Roberts’ contention that courts should defer to the FDA’s decision not to relax the in-person requirement during the pandemic, Sotomayor – who has joined Roberts in voting to deny challenges from religious institutions seeking to loosen limits on in-person attendance at worship services – conceded that she “agree[d] that deference is due to reasoned decisions of public health officials grappling with a deadly pandemic.” But in this case, she noted, the FDA has not explained why it has decided to enforce the in-person requirement during the pandemic, even while waiving similar requirements for other drugs. “There simply is no reasoned decision here to which this Court can defer.”

Laws in the United States, Sotomayor stressed, “have long singled out abortions for more onerous treatment than other medical procedures that carry similar or greater risks.” The in-person requirement, she concluded, “imposes an unnecessary, irrational, and unjustifiable undue burden on women seeking to exercise their right to choose. One can only hope that the Government will reconsider and exhibit greater care and empathy for women seeking some measure of control over their health and reproductive lives in these unsettled times.”

The court’s order came nearly one month after the FDA’s request was fully briefed. There was no explanation for the court’s delay. Although Tuesday’s ruling gives the FDA the green light to reinstate the in-person requirement immediately, the Biden administration could opt to waive the requirement, either for the duration of the pandemic or more permanently.

This article was originally published at Howe on the Court.