States Urge High Court To Revive FDA's Abortion Pill Rules

By Kevin Stawicki
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Law360 (August 31, 2020, 4:32 PM EDT) -- Nearly a dozen states are throwing their support behind the U.S. Food and Drug Administration's attempt to convince the U.S. Supreme Court to hit pause on an injunction that requires the agency to increase access to the so-called abortion pill.

In an amicus brief filed Friday, Texas, Indiana and eight other states backed the FDA's recent request that the justices undo an injunction that blocks the agency's restrictions on patients' ability to get Mifeprex, a pill that ends pregnancy at up to 10 weeks, at a retail pharmacy.

The FDA asked the justices on Aug. 26 to pause the Fourth Circuit's refusal to lift an injunction, which determined that the agency's restrictions requiring patients to be handed the medication at a clinic or hospital by a preregistered health care provider were an "undue burden."

Because appellate courts have had different takes on the Supreme Court's ruling in June Medical Services v. Russo, which struck down a Louisiana law requiring abortion providers to have admitting privileges at nearby hospitals, the states said the justices should clear up the confusion about how to interpret the opinion.

The states specifically asked for clarification of a concurrence by Chief Justice John Roberts Jr., who said the law should be invalidated but that judges hearing abortion challenges should not engage in a "balancing test" of competing interests between the government and the abortion patient.

"If, in granting the stay application, the court could at least clarify whether lower courts should balance benefits and burdens of abortion regulations — as the district court did here — or merely examine the record for evidence of a substantial obstacle — as the chief justice indicated in his June Medical concurrence — lower courts could address those pending disputes using the proper test," the states wrote.

The states also took the opportunity to drive home their argument that state and federal laws requiring women to undergo physical examinations and obtain mifepristone in person to protect against risks including infection, hemorrhage or death "are not unduly burdensome even in the current public health emergency."

"The COVID-19 pandemic only reinforces the need to follow reasonable guidelines when prescribing potentially dangerous or life-threatening medications. To argue otherwise is to disregard women's health and safety in the name of convenience," Texas Attorney General Ken Paxton said in a statement. "This medication is strictly required to be dispensed in person due to the serious risks it poses."

Friday's brief comes just days after the FDA said its request to stay the injunction meets all the factors warranting a green light from the justices, in particular that there's a high likelihood that the court will eventually grant certiorari of the lower court's decision.

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

Whether June Medical eliminated the cost-benefit test for abortion laws was a question that immediately arose after the justices decided the case in June. The Supreme Court created the test four years ago in Whole Woman's Health v. Hellerstedt , while simultaneously saying the test had essentially existed since 1992, when the Supreme Court in Planned Parenthood v. Casey barred laws that impose an "undue burden" on abortion access.

If the cost-benefit test no longer exists after June Medical, it will be easier for anti-abortion laws and regulations to withstand legal challenges, as some courts applying the test have found that many abortion laws lack significant medical benefits.

The suit, filed by the American College of Obstetricians and Gynecologists and other physician groups in May, claims the restrictions 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 women seeking the pill.

Counsel and representatives for the states, physician groups and the FDA did not immediately respond to requests for comment Tuesday.

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 Joshua Dos Santos of the U.S. Department of Justice's Civil Division and acting Assistant Attorney General Ethan P. Davis and Senior Counsel to the Assistant Attorney General Sophan Joshi.

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 Jimmy Hoover and Craig Clough. Editing by Stephen Berg.

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