The Department of Justice under President Joe Biden is petitioning the Supreme Court to reverse a lower court ruling.
The ruling halted two Food and Drug Administration (FDA) actions that loosened restrictions on mifepristone, the first tablet in a two-drug chemical abortion regimen, as Breitbart News reported.
Solicitor General Elizabeth Prelogar told the high court in a petition for a writ of certiorari filed on Friday that if the lower court decision is allowed to take effect, it would cause a disruption within the system to issue the abortion drug.
According to the filing, it would "up-end the regulatory regime for mifepristone with damaging consequences for women seeking lawful abortions and a healthcare system that relies on the availability of the drug under the current conditions of use."
Danco Laboratories LLC, which distributes mifepristone under the brand name Mifeprex, also filed a certification petition on Friday, according to a press release from the company.
“As Danco’s petition explains, the case presents a serious question: whether courts can disregard constitutional and statutory limits on judicial review of agency action to overrule agency decisions that they dislike,” the company said in a statement.
“Danco asks the Court to grant review of both the determination that doctors who do not prescribe or want to prescribe Mifeprex® have standing and the determination that FDA acted unreasonably in approving the changes in 2016 and 2021 despite the extensive study and other data supporting those decisions.”
A three-judge panel of the conservative U.S. Court of Appeals for the Fifth Circuit ruled in August that the FDA's 2016 decision to allow the abortion pill to be taken later in pregnancy is unconstitutional.
The court reached the same conclusion regarding the FDA's 2021 rule change, which permitted the abortion pill to be dispatched directly to patients and authorized medical professionals other than physicians to prescribe mifepristone.
“In loosening mifepristone’s safety restrictions, FDA failed to address several important concerns about whether the drug would be safe for the women who use it,” reads the panel opinion, penned by Judge Jennifer Walker Elrod.
“It failed to consider the cumulative effect of removing several important safeguards at the same time. It failed to consider whether those ‘major’ and ‘interrelated’ changes might alter the risk profile, such that the agency should continue to mandate reporting of non-fatal adverse events,” the opinion continued.
“And it failed to gather evidence that affirmatively showed that mifepristone could be used safely without being prescribed and dispensed in person.”
Elrod wrote that plaintiffs “have made a substantial showing” that the 2016 and 2021 rule changes violate the Administrative Procedure Act (APA).
Despite the Fifth Circuit's ruling against the government and the drug manufacturer, mifepristone has remained available in accordance with current regulations as the litigation continues.
The Supreme Court preemptively paused any judgment from an appeals court this spring, pending a petition for the Supreme Court to take the case. If the Supreme Court does not accept the case, the order of the Fifth Circuit will be implemented.