High Court Punts FDA Bid To Revive Abortion Pill Restriction

By Hannah Albarazi
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Law360 (October 8, 2020, 10:50 PM EDT) -- The U.S. Supreme Court on Thursday declined a request to immediately revive restrictions on the abortion drug mifepristone during the pandemic, sending the case back to the district court over objections from Justices Clarence Thomas and Samuel A. Alito that the court is treating abortion cases differently from religious liberty cases.

The high court decided, for now, not to grant the U.S. Food and Drug Administration's request to stay a nationwide injunction blocking the agency from enforcing its restrictions on patients' ability to get the so-called abortion pill, which ends pregnancy at up to 10 weeks, at retail pharmacies.

Justice Alito, joined in his dissent by Justice Thomas, wrote that he sees little difference between the court's punting of the case and an express denial of the government's application. But there is one difference, he said.

"Expressly denying a stay would highlight the inconsistency in the Court's rulings on COVID-19-related public safety measures," Justice Alito wrote.

Justice Alito said state and local officials have imposed "unprecedented restrictions on personal liberty" since the pandemic began, including severe limitations on First Amendment rights.

"Officials have drastically limited speech, banning or restricting public speeches, lectures, meetings, and rallies. The free exercise of religion also has suffered previously unimaginable restraints, and this Court has stood by while that has occurred," Justice Alito wrote.

Justice Alito said that if the FDA is right in its assessment of mifepristone, not enforcing the requirement that patients obtain the drug in-person from a health care provider could risk irreparable harm.

But Julia Kaye, staff attorney at the American Civil Liberties Union Reproductive Freedom Project and a lead attorney for groups challenging the FDA rule, said the high court's opinion Thursday is only a slight relief.

"It is a relief that, for the next few weeks at least, the Trump administration cannot force patients who need an early abortion to needlessly risk contracting a life-threatening disease as a condition of obtaining care," Kaye said in a statement Thursday. 

"But when the president has vowed to appoint a new justice who will overrule Roe v. Wade, the fact that the Supreme Court decided to stay out of this particular fight for now is hardly an indication that the right to abortion is secure. Let's be clear: The next justice confirmed to the court will dictate whether or not many people in this country can get a safe, legal abortion when they need one," Kaye said.

The suit, filed by the American College of Obstetricians and Gynecologists and other physician groups in May, claims the restrictions on obtaining mifepristone violate a patient's rights to equal protection of the law under the U.S. Constitution and that COVID-19 only heightened the risk for those seeking the drug.

A Maryland federal judge granted the injunction, suspending the FDA's rule requiring those seeking to end their pregnancies using medication to obtain the pill at a hospital, clinic or medical office by a health care provider who has preregistered with the drug's manufacturer. The Fourth Circuit in August refused to lift the injunction.

Texas, Indiana and eight other states backed the FDA's request for the high court to hit pause on the injunction, arguing that state and federal laws requiring patients to undergo physical examinations and obtain mifepristone in-person to protect against risks including infection, hemorrhage or death are not unduly burdensome, even during a pandemic.

But nearly two dozen Democratic attorneys general told the justices in September that the FDA's rule threatens public health during the pandemic by forcing patients to potentially contract COVID-19 to obtain the pill.

Of the 20,000 drugs the FDA regulates, mifepristone is the only one where a patient is required to pick up the pill in-person at a health center, the ACLU said, even though they can then choose to ingest it at later time.

The FDA maintains that U.S. District Judge Theodore D. Chuang, who granted the injunction, improperly used the cost-benefit balancing test rejected by Chief Justice Roberts when he should have adhered to the test, which considers whether the law imposed a burden on people seeking abortions.

The high court majority said Thursday that a more comprehensive record would aid their review and instructed the district court to rule within 40 days of receiving the government's request.

But Justice Alito slammed the decision, writing, "There is no legally sound reason for this unusual disposition."

Skye Perryman, chief legal officer of the American College of Obstetricians and Gynecologists, said in a statement Thursday, "We are pleased the injunction blocking FDA's medically unnecessary restriction will stay in place — for the time being."

"The in-person dispensing requirement is not grounded in science, it is not necessary for patient safety, and it is yet another example of women's health being held to a different standard than the rest of medicine," Perryman said.

Counsel and representatives for the government did not immediately respond to requests for comment Thursday afternoon.

The physician groups are represented by Julia Kaye, Anjali Dalal, Ruth Harlow, Rachel Reeves and Jennifer Dalven of the American Civil Liberties Union Foundation, and John A. Freedman, R. Stanton Jones, David J. Weiner, Jocelyn A. Wiesner, Andrew Tutt and Gina Colarusso of Arnold & Porter.

The FDA is represented by Ethan P. Davis, Sopan Joshi and Joshua Dos Santos of the U.S. Department of Justice's Civil Division.

The case is U.S. Food and Drug Administration et al. v. American College of Obstetricians and Gynecologists et al., case number 20A34, in the U.S. Supreme Court.

--Additional reporting by Kevin Stawicki. Editing by Breda Lund.

For a reprint of this article, please contact reprints@law360.com.

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