The legal kerfuffle over the FDA’s 2000 approval of Danco Laboratories’ abortion pill mifepristone, also known as Mifeprex, is heading to the Supreme Court.
Friday, Danco asked the Supreme Court to overturn a recent U.S. Court of Appeals for the Fifth Circuit ruling that would severely limit access to the abortion pill mifepristone.
“The risks and confusion that result from the Fifth Circuit’s decision are not ones that women, teenage girls, and the public health system should be forced to bear without this Court’s review,” Danco’s lawyers wrote in a legal filing.
“Denying review of the Fifth Circuit’s opinion would eviscerate the sovereign authority of states that have chosen to expand and protect access to medication abortion in their jurisdictions,” Danco’s legal team continued, adding that the case is of “indisputable importance.”
Mifepristone remains unrestricted until the Supreme Court weighs in on the case. Medication abortion makes up the majority of abortions obtained in the U.S., CNN notes.
Notably, Danco’s plea for the Supreme Court to hear the case comes a little more than a year after the court’s conservative majority overturned Roe v. Wade, which protected abortion as a constitutional right.
Now, Danco argues the High Court should take up the case given the “national importance” of the issues at play.
The case “raises questions about whether a single federal court can limit abortion access in the states that protect it,” and risks “[destabilizing] the pharmaceutical and biotechnology industries by questioning when scientific studies—accepted by the FDA—are sufficient to support conditions of use…”
In November, the Alliance for Hippocratic Medicine filed a complaint, alleging that the FDA had rushed its 2000 approval of the drug. The plaintiffs argued that the agency justified the decision by labeling pregnancy as an "illness" and asserting that Mifeprex offered a "meaningful therapeutic benefit" compared to existing treatments.
“In asserting these transparently false conclusions, the FDA exceeded its regulatory authority to approve the drugs,” the suit said.
The FDA itself hit back in January, contending that the plaintiffs had decided to challenge its regulatory action “long after the limitations period has expired.”
The FDA argued that the suit failed to prove that the plaintiffs are suffering imminent and irreparable harm. Their “speculative assertions of injury,” which were “made months and even decades” after the approval in question, are “unsupported by any evidence," the FDA said.

https://www.fiercepharma.com/pharma/danco-takes-mifepristone-restrictions-lawsuit-supreme-court