The judges ask the FDA to dam the mail supply of abortion drugs

The Supreme Court on Tuesday filed a motion from the Food and Drug Administration to reinstate a federal obligation that a pill used for abortion in the early stages of pregnancy must be picked up in person by a health care provider. A federal district judge suspended that request last summer because of the COVID-19 pandemic and then upheld that ruling after the judges ordered the FDA back in October to seek closer relief.

The new Supreme Court order means the FDA can re-enforce regulations that require face-to-face visits, though its willingness to do so could change once President-elect Joe Biden takes over next week. The judges split ideologically in the Food and Drug Administration v American College of Obstetricians and Gynecologists, with the court’s three liberal judges saying they had rejected the government’s motion.

The regulations at the center of Tuesday’s order govern the dispensing of mifepristone, a drug that the FDA has approved for terminating pregnancies in the first 10 weeks. According to FDA regulations, patients who wish to use the drug to terminate their pregnancy are required to sign a form acknowledging the risks associated with the drug and have the pill, often made under the brand name Mifeprex, be purchased by a healthcare provider in a medical environment. Once they collect the medicine from a hospital or clinic, patients can take the pill at home, but they cannot receive the pill in the mail.

The American College of Obstetricians and Gynecologists went to federal court in Maryland last year, arguing that requiring patients to personally visit their health care providers in the middle of a pandemic is against the constitution by creating a significant barrier to obtaining an abortion. U.S. District Court Judge Theodore Chuang agreed with ACOG and passed an order in July banning the FDA from enforcing personal requirements anywhere in the U.S. until the pandemic is over.

After the U.S. 4th Circuit Court of Appeals denied the FDA’s motion to postpone Chuang’s decision while the FDA appealed, the FDA went to the Supreme Court on Aug. 26. However, the judges didn’t act until October 8th when they issued a one-paragraph order refusing to resolve the FDA’s request. The FDA had argued, the court stated, that Chuang’s order was – at least – too comprehensive as it applies to all 50 states, regardless of COVID-19 rates in certain states. On the grounds that more information would help them, the judges said the FDA should return to the district court to ask Chuang to revoke, amend, or freeze his order, “also on the grounds that the relevant circumstances are changing to have”. Chuang, the court also made it clear, “should rule within 40 days of the government submission.”

On December 9, Chuang issued a new order denying the FDA’s request to suspend or terminate his previous order. Chuang stressed that his order to prevent the FDA from enforcing the personal requirement was “not perpetual,” especially given the “positive news regarding vaccines,” and concluded that the FDA was in this “deadliest period.” the pandemic “had not shown that circumstances had not improved enough to warrant changes to his July order.

The FDA returned to the Supreme Court on Dec. 15, arguing – as in its original filing – that enforcement of the regulations does not materially hinder a woman’s ability to obtain an abortion. Patients can always get a surgical abortion, it noted. Additionally, according to the FDA, two states – Indiana and Nebraska – independently require that patients personally collect the pill from their health care provider. The number of abortions in these states actually increased during the pandemic, the FDA pointed out, refuting any idea that the need for personal visits would make it difficult to obtain an abortion.

In its response, ACOG stressed that patients “were already free to have their assessment and advice carried out via telemedicine and to swallow the mifepristone tablet at the time and place of their choice”. By prohibiting the FDA from requiring a face-to-face visit to actually pick up the pill, the district court order helps “avert it[] serious viral risks. “And although the district court order had been in place for nearly six months, ACOG wrote, the FDA had provided no evidence that anyone had been harmed by the ability to receive mifepristone without a personal visit. Eventually, ACOG concluded that the opposite was true, although the Supreme Court may have “hoped the pandemic would subside” in October when it sent the case back to the District Court for reconsideration. “There are even fewer bases to support a stay today than in October when this court initially refused to grant one,” ACOG said.

In a brief decision late Tuesday afternoon, nearly a month after the Trump administration submitted its letter of reply in support of its motion, the court granted the motion. The court’s decision enables the FDA to enforce the personal rule while it continues its appeal against Chuang’s order on the matter.

Chief Justice John Roberts wrote a separate statement agreeing to the decision to put Chuang’s order on hold and allow the FDA to enforce the personal request pending appeal. Roberts stressed that the question for judges at the time was not whether the personal requirement made it difficult for women to obtain abortions. Instead, the question is whether Chuang rightly instructed the FDA to lift the personal requirement based on his “own assessment of the effects of the COVID-19 pandemic”. Roberts reiterated his view that the pandemic-related courts should not generally question “politically accountable entities with the background, competence and expertise to assess public health” and concluded that Chuang asked the FDA, to relax the personal requirements.

Judge Stephen Breyer said he would reject the FDA’s application. He did not join the separate dissent of Justice Sonia Sotomayor, which Justice Elena Kagan joined. Because of the pandemic, Sotomayor said, the Centers for Disease Control have generally encouraged healthcare providers to use telemedicine for appointments whenever possible. However, the government has refused to do this for women looking for drug discontinuation. In addition, Sotomayor added, the pandemic has worsened since October when the FDA first asked the government to reintroduce the personal requirement.

Turning to the FDA’s motion, Sotomayor argued that enforcing the personal requirement “unnecessarily and inappropriately encroaches” on a woman’s right to abortion. Women seeking an abortion are already at risk of complications from COVID, Sotomayor explained, because they are pregnant and more likely to be skin color and low-income women. Difficulties with abortion are getting worse, she added, because “the availability of medical offices has dropped dramatically during the pandemic”. As a result, the district court found that “these obstacles can cause women to miss the 10-week window for a drug abortion altogether.”

Sotomayor harshly criticized the FDA’s suggestion that women, even if they can’t get a drug discontinuation in time, can still get a surgical termination. “What a callous answer,” Sotomayor replied. Surgical abortions are “far more invasive” and riskier than drug abortions.

Sotomayor responded to Roberts’ claim that the courts should postpone the FDA’s decision not to relax personal requirements during the pandemic. He has joined Roberts in opposing the challenges of religious institutions trying to relax the limits of personal attendance at church services – admitted that she “agrees[d] This respect stems from reasoned decisions made by public health officials dealing with a deadly pandemic. “In this case, however, the FDA did not explain why it decided to enforce the personal requirements during the pandemic, although similar requirements for other drugs were waived. “There is simply no reasoned decision here for this court to postpone.”

Laws in the United States, Sotomayor pointed out, “have long singled out abortion as a more burdensome treatment than other medical procedures that carry similar or greater risks.” The personal requirement, she concluded, “places an unnecessary, irrational and unjustifiable undue burden on women seeking to exercise their right to vote. One can only hope that the government will rethink and show more care and empathy for women seeking some degree of control over their health and reproductive life in these troubled times. “

The court order came almost a month after the FDA was fully informed of the request. There was no explanation for the court’s delay. Although Tuesday’s decision gives the FDA the green light to reinstate the personal requirement immediately, the Biden government could decide to waive the requirement for either the duration of the pandemic or more permanently.

This article was originally published by Howe on the Court.

Posted in Food and Drug Administration versus American College of Obstetricians and Gynecologists, Featured, Emergency Appeals and Applications

Recommended citation:
Amy Howe, Judge Grant FDA Motion To Block Mail Delivery Of Abortion Pills,
SCOTUSblog (January 12, 2021, 7:51 p.m.),

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