DOJ and Mifepristone maker urge Supreme Court to preserve full access to abortion pill

By Devan Cole, CNN

(CNN) — The Justice Department and the manufacturer of a widely used abortion pill urged the Supreme Court on Tuesday to preserve full access to the drug, warning that a lower-court ruling restricting its availability “threatens profound harms” nationwide.

“The loss of access to mifepristone would be damaging for women and healthcare providers around the Nation. For many patients, mifepristone is the best method to lawfully terminate their early pregnancies,” Solicitor General Elizabeth Prelogar told the justices in court papers.

“There is no equitable justification for allowing parties whose asserted injuries are at best attenuated – and whose relevant claims assert only that FDA failed adequately to explain its actions – to secure disruptive nationwide relief that threatens profound harms to the government, the healthcare system, patients, and the public,” Prelogar wrote.

The pair of filings from the Justice Department and Danco Laboratories, a manufacturer of the drug and an intervenor in the case, lay out their arguments for why the justices should overturn the lower-court ruling that curbed access to mifepristone, including that the pill’s challengers didn’t have the legal right – known as “standing” – to sue the government over its approval of the drug and the regulatory regime that eased access to it.

“The Fifth Circuit ran roughshod over this Court’s precedents,” attorneys for Danco wrote in their filing. “The court’s standing analysis would give medical organizations standing to challenge virtually every government regulation that touches on health or safety.”

The justices agreed last year to review the case, though the court has not yet scheduled oral arguments. More briefs from the parties are expected in the coming weeks.

In its filing Tuesday night, the drugmaker, like the government, defended the US Food and Drug Administration’s 2000 approval of mifepristone and the agency’s subsequent actions concerning the drug. The company argued that the legal analysis employed by the New Orleans-based appeals court to limit access to the drug “threatens to destabilize the pharmaceutical industry, which relies both on FDA’s ability to make predictive judgments and on courts not second-guessing those scientific judgments.”

For now, mifepristone remains available and not subject to restrictions that the lower courts have said should be imposed on its use. The high court determined in April 2023 that access to the drug would remain unchanged until the appeals process finishes.

Central to the dispute is the scope of the FDA’s authority to regulate mifepristone, a drug that the medical community has deemed safe and effective and is used by more than half of women to terminate their pregnancies, according to the government.

Challengers – including doctors and groups who oppose abortion – argue that the FDA did not do enough to study the safety implications of the drug when it approved its use and made it more easily accessible in subsequent years.

A federal judge in Texas agreed last spring, issuing a ruling that would have halted the FDA’s 2000 approval of the drug. The 5th US Circuit Court of Appeals backtracked somewhat, saying in August that while it was too late for the challengers to mount a case against the initial 2000 approval of the drug and left in place the 2019 approval of a generic version of the drug, it would block changes made in 2016 and 2021 that made the drug more easily accessible.

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