In early April, a federal district judge in Texas ruled that the Food and Drug Administration's initial approval and subsequent regulatory changes of an abortion-inducing drug were unlawful, and a federal appeals court panel then partially upheld that ruling and prompted an appeal to the U.S. Supreme Court.
The Supreme Court has now placed a temporary administrative stay to place the entire thing on hold while the appeals process plays out, Breitbart reported.
That means that the status quo before the district court's ruling, in which the FDA-approved abortion drug mifepristone was widely available and easily accessible, is now once again in place for the time being.
On April 7, according to CBS News, U.S. District Judge Matthew Kacsmaryk issued a nationwide injunction to block mifepristone after he ruled that the FDA's approval of the drug in 2000 had been unlawful, as were several subsequent regulatory changes made by the FDA in recent years.
That included a 2016 extension of the gestational age limit from 7 weeks to 10 weeks, a reduction in required in-person clinic visits, and a broadening of who was allowed to prescribe the drug. It also included a 2019 rule change allowing a cheaper generic version and a 2021 rule change that allowed the drug to be prescribed without an in-person clinic visit and be delivered through the mail.
The ruling was immediately appealed to the 5th Circuit Court of Appeals and a three-judge panel struck down the injunction as it pertained to the initial approval of the drug but upheld the injunction as it applied to the later rule changes that made the drug more accessible, effectively restoring the status quo that had been in place from 2000-2016.
Meanwhile, the matter was further complicated when a district judge in Washington state issued a conflicting ruling in a separate but related case shortly after the Texas judge's ruling that prohibited the FDA or the drug's distributor from removing mifepristone from the market.
SCOTUSblog reported that the 5th Circuit's ruling was then immediately appealed to the Supreme Court and Justice Samuel Alito, who has jurisdiction over that circuit, issued a temporary stay to place everything on hold until a hearing could be held on the matter.
Friday evening, the court issued an unsigned order in which the majority granted the request for a stay on the entire district court order while the appeals process on the merits of that ruling played out in the 5th Circuit.
The high court's order noted that Justice Clarence Thomas would have denied the application for a stay without explanation and also included a four-page dissent from Alito in which he explained why he also would have denied the request.
Alito asserted that contrary to the arguments of the Biden administration and the pharmaceutical company, Danco Laboratories, a denial of the requested stay "would not remove mifepristone from the market. It would simply restore the circumstances that existed (and that the Government defended) from 2000 to 2016 under three Presidential administrations."
He also noted that because the case had been fast-tracked in the 5th Circuit, with a hearing scheduled for next month, "there is reason to believe that they would get the relief they now seek -- from either the Court of Appeals or this Court -- in the near future if their arguments on the merits are persuasive."
Alito further stated that the administration and Danco had failed to prove that they would suffer "irreparable harm" in the absence of the stay and accused the FDA of purposefully "leveraging" the supposed "chaos" caused by the Washington state court ruling in conflict with the Texas ruling as a means "for implementing a desired policy while evading both necessary agency procedures and judicial review."
He also dismissed Danco's concerns about being subject to adverse enforcement measures by the FDA when there was no "reason to believe the FDA would make that choice" when such enforcement was discretionary, not to mention the fact that the Biden administration "has not dispelled legitimate doubts that it would even obey an unfavorable order in these cases, much less that it would choose to take enforcement actions to which it has strong objections."
