DOJ to Ask Supreme Court to Intervene in Abortion-Pill Case (3)

Attorney General Merrick Garland said the Biden administration will ask the US Supreme Court to protect the availability of a widely used abortion pill after a federal appeals court cleared the way for new restrictions to take effect Friday.

“We will be seeking emergency relief from the Supreme Court to defend the FDA’s scientific judgment and protect Americans’ access to safe and effective reproductive care,” Garland said in a statement.

The announcement comes after the 5th US Circuit Court of Appeals late Wednesday partially stayed a ruling that would have suspended mifepristone’s approval by the Food and Drug Administration. Under the appeals court order, mifepristone would remain an option for many patients, but it could no longer be prescribed after the seventh week of pregnancy or dispensed by mail.

The administration is likely to ask the Supreme Court to keep mifepristone fully available while a government appeal goes forward. The Justice Department might also seek an administrative stay, which would put the lower court rulings on hold while the justices consider a longer delay.

Any filing would go to Justice Samuel Alito, who is assigned to handle emergency matters from the New Orleans-based 5th Circuit.

Alito, who wrote the court’s 2022 decision overturning the constitutional right to abortion, probably will refer the matter to the full nine-member court, as justices typically do in divisive cases, though he could act alone on a request for an administrative stay.

US District Judge Matthew Kacsmaryk ruled last week that the FDA gave short shrift to safety concerns when it approved mifepristone in 2000. He said the agency was facing political pressure to back the drug and improperly used a fast-track process designed for treatments for serious illnesses.

Kacsmaryk, a Donald Trump appointee who has written critically about the Roe v. Wade abortion-rights ruling, also said the FDA violated an 1873 law when the agency said in 2021 that mifepristone could be dispensed by mail.

The 5th Circuit, probably the nation’s most conservative appeals court, voted 2-1 to let part of Kacsmaryk’s order take effect. The majority said anti-abortion opponents waited too long to sue over the original approval decision but had strong arguments that the FDA ignored safety concerns when it loosened restrictions on the drug starting in 2016.

Kacsmaryk’s initial order was followed almost immediately by a contradictory ruling from a federal judge in Yakima, Washington, who told the government to preserve access to the pill.

On Thursday, US District Judge Thomas Rice doubled down, writing in a clarification of his order that irrespective of the Texas case, the FDA and the Department of Health and Human Services are prohibited from changing the status quo as it relates to the availability of mifepristone.

Rice’s order means that, barring Supreme Court intervention, the government would find itself having to deal with two opposing rulings from two judges.

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The Biden administration told the 5th Circuit that Kacsmaryk’s ruling would deprive patients of what in many cases is the safest and most practical method to end a pregnancy. The government contends the trial judge’s order marks an unprecedented judicial intrusion on the drug-approval process and the FDA’s scientific judgment.

The administration also says the groups challenging mifepristone, including an association of obstetricians and gynecologists, haven’t shown they are being harmed by the drug’s availability.

Danco Laboratories LLC, the drug’s primary maker, is defending the FDA’s approval decisions alongside the Biden administration. Kacsmaryk’s decision drew backlash from drug manufacturers and pharmaceutical executives, who said it ignores decades of legal precedent and undermines the FDA’s authority to regulate drugs.

If access to mifepristone is restricted, those seeking to terminate pregnancies would have to use misoprostol, a less-effective single-pill regimen, or obtain a surgical abortion in states where the procedure is still legal. Several states including New York, Massachusetts, Washington and California have announced plans to stockpile misoprostol following the Texas decision.

(Updates with Washington court ruling in 10th paragraph.)

--With assistance from Madlin Mekelburg.

To contact the reporter on this story:
Greg Stohr in Washington at gstohr@bloomberg.net

To contact the editors responsible for this story:
Elizabeth Wasserman at ewasserman2@bloomberg.net

Joe Schneider

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