Supreme Court Gives FDA Temporary Victory
The U.S. Supreme Court late 4/21 granted FDA a stay of Texas federal judge Matthew Kacsmaryk’s nationwide ban on mifepristone while it is appealed in the U.S. Court of Appeals for the Fifth Circuit. Oral arguments are on fast track in that venue and are scheduled to begin 5/17.
FDA’s appeal, filed by the Department of Justice, “concerns unprecedented lower court orders countermanding FDA’s scientific judgment and unleashing regulatory chaos by suspending the existing FDA-approved conditions of use for mifepristone,” the government said. Approved in 2000, FDA has maintained its scientific judgment “across five presidential administrations, and it has modified the original conditions of mifepristone’s approval as decades of experience have conclusively demonstrated the drug’s safety,” it contended.
The appeal said that the district court’s order would nullify FDA’s approval and effectively prohibit mifepristone from being introduced into interstate commerce, “upending the status quo based on the court’s deeply misguided assessment of mifepristone’s safety… The Fifth Circuit stayed the district court’s suspension of FDA’s original approval of mifepristone. But it refused to stay the suspension of subsequent updates to the conditions on the drug’s use, which have governed the drug’s distribution for seven years and provided a safe and effective option for women who would otherwise have to undergo a surgical abortion.”
The Supreme Court’s 4/21 order says the stay is in place while the Fifth Circuit weighs the merits of the case. “Should certiorari be denied, this stay shall terminate automatically,” it notes. “In the event certiorari is granted, the stay shall terminate upon the sending down of the judgment of this court.”
Meanwhile, HHS supported the Supreme Court’s intervention, with HHS secretary Xavier Becerra saying: “Today's action from the Supreme Court is an important step in the right direction as we vigorously fight to defend the FDA’s independent, expert authority to review, approve, and regulate a wide range of prescription drugs. We are confident the law is on our side and remain focused on prevailing in court. Mifepristone remains approved and available as this case winds through the courts. We will never stop fighting to preserve women’s rights to access the health care they need and Americans’ rights to access safe and effective medicine.”
Additionally, the drug industry hailed the decision as a welcome step. Pharmaceutical Research and Manufacturers of America reiterated its amicus brief in the matter, stating that “Congress gave the FDA the authority to determine whether a medicine is safe and effective for patients to use. Allowing the courts to second-guess a decision by the FDA to approve a medicine would create significant uncertainty and harm for manufacturers, patients and physicians. We will remain engaged to help ensure the concerns of our members are heard as the legal process unfolds.”