In the wake of last year’s court decision to limit the FDA’s approval for the medication abortion pill mifepristone, many drugmakers, trade groups and even the U.S. president himself have challenged the ruling.
Now, the Biden Administration and mifepristone’s manufacturer, Danco Laboratories, are getting their day in court, as they attempt to fight one of the most pivotal battles surrounding reproductive health since the Supreme Court overturned Roe v. Wade in 2022.
On Tuesday, the High Court is set to hear oral arguments in two consolidated cases brought by the Biden Administration and Danco Labs striking back at last April’s Fifth Circuit appeals decision, which prohibited the pill to be delivered by mail and restricted the time frame the med can be used during pregnancy from 10 to 7 weeks.
After listening to Tuesday’s cases, the Supreme Court is expected to issue its final ruling by the end of June this year.
Mifepristone was originally approved by the FDA in 2000. In 2016, the approval was expanded to allow nurse practitioners, and not just doctors, to prescribe the drug while boosting the gestational age cutoff from 7 to 10 weeks. In 2021, amid the COVID-19 pandemic, the approval was expanded again to remove the in-person administration requirement, teeing up mifepristone delivery through the mail.
For the time being, justices have paused the appeals ruling until the Supreme Court has its say, meaning mifepristone can still be received via post and taken up to 10 weeks into pregnancy.
The plaintiffs in the original mifepristone lawsuit, the conservative Alliance Defending Freedom, filed its case against the FDA back in Nov. 2022. The complaint was brought forward by four anti-abortion medical organizations and four doctors who have treated patients with the drug.
The group argued that the U.S.’s drug regulator rushed its original 2000 approval of mifepristone and justified the decision by branding pregnancy an “illness.”
Come January of 2023, the FDA hit back in a separate filing in Texas federal court, suggesting the Alliance Defending Freedom was challenging its regulatory action “long after the limitations period [had] expired.” The agency went on to argue against the plaintiffs’ “speculative assertions of injury” against pregnant women that were “made months and even decades” after the approval in question.
The FDA, and many allies in the form of biopharma companies and the influential trade group the Pharmaceutical Research and Manufacturers of America (PhRMA), contend that if the mifepristone injunction were allowed to stand, it would undermine the agency’s regulatory autonomy conferred by Congress.
The case was ultimately taken up by the Supreme Court in December, following entreaties from PhRMA, the Biden Administration and Danco Labs. In an amicus brief filed in October, PhRMA argued that the decision could make the FDA’s regulatory calls “mere precursors to litigation, rather than durable decisions,” suggesting the move could create uncertainty around virtually any drug on the market.
The Biden Administration, via the U.S. Solicitor General Elizabeth Prelogar, called the appeals court’s ruling an “unprecedented decision” that would threaten the FDA’s decision-making power. The approach could have the unintended effect of calling into question “countless other drug approvals,” Prelogar wrote in November.
Danco Labs, for its part, has called on the Supreme Court to overturn the appeals verdict, arguing that “risks and confusion” from the Fifth Circuit’s decision would unfairly fall upon women, teenage girls and the public health system.