DOJ Asks Supreme Court to Keep Abortion Pill Fully Available

The Biden administration asked the US Supreme Court to keep a widely used abortion pill fully available and pause court-ordered restrictions that are set to take effect Friday.

(Bloomberg) — The Biden administration asked the US Supreme Court to keep a widely used abortion pill fully available and pause court-ordered restrictions that are set to take effect Friday.

The filing comes after a federal appeals court partially stayed a ruling that would suspend 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 or by non-physicians.

US Solicitor General Elizabeth Prelogar asked the high court to go further and put all of US District Judge Matthew Kacsmaryk’s order on hold while the FDA presses an appeal. Prelogar, the Biden administration’s top courtroom lawyer, is also seeking a short-term administrative stay while the justices consider whether to grant the longer-term halt throughout the appeal.

“The resulting loss of access to mifepristone would be profoundly damaging,” Prelogar argued. “For many patients, mifepristone is the best method to lawfully terminate their pregnancies. They may choose mifepristone over surgical abortion because of medical necessity, a desire for privacy, or past trauma.”

The administration suggested the court alternatively could grant review and hear arguments on an expedited basis during its current term. Danco Laboratories LLC, the drug’s primary maker, filed a similar request with the court earlier Friday.

Alito Role

The request will go to Justice Samuel Alito, who is assigned to handle emergency matters from the New Orleans-based 5th US Circuit Court of Appeals.

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. He could also act alone on the request for an administrative stay.

The lower court orders would affect the most common method for terminating a pregnancy, restricting access even in states where abortion is otherwise legal. Mifepristone was approved by the FDA more than two decades ago but that abortion opponents now contend is unsafe. 

Kacsmaryk, a Donald Trump appointee who has written critically about the Roe v. Wade abortion-rights ruling, said 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.

He also said the FDA violated an 1873 law when the agency said in 2021 that mifepristone could be dispensed by mail.

Kacsmaryk brushed aside objections that the anti-abortion groups challenging the approval waited far too long to file their lawsuit — and hadn’t shown they were being harmed by mifepristone’s availability.

5th Circuit Blasted

The Biden administration says the judge’s order marks an unprecedented judicial intrusion on the drug-approval process and the FDA’s scientific judgment. 

Prelogar blasted the 5th Circuit’s handling of the case, faulting the panel for issuing a 42-page order only hours after briefing was completed and for refusing to grant a short-term administrative stay.

“That order completely transformed the case: The 5th Circuit declined to adopt much of the district court’s reasoning, injected new legal issues, expanded the agency actions under review, and granted a partial stay without apparent appreciation for its disruptive practical consequences,” she said.

“The court of appeals did all that just 48 hours before the district court’s order is set to take effect — yet it refused to grant even a modest reprieve to allow this court to consider the government’s stay request in an orderly fashion.”

–With assistance from Madlin Mekelburg.

(Updates with excerpts from filing starting in fourth paragraph.)

More stories like this are available on bloomberg.com

©2023 Bloomberg L.P.