BIO Files Amicus Brief in Continuing Effort to Preserve FDA’s Expert, Scientific Authority on Drug Approvals
October 12, 2023
BIO filed an amicus brief in a continuing effort to challenge courts' decisions that undermine FDA authority and hinder patient access to medications.
The brief was filed in the Supreme Court of the United States (SCOTUS), following the August 2023 ruling of the U.S. Court of Appeals for the Fifth Circuit, which held that FDA's approvals of various changes to the prescribing conditions for a drug (mifepristone) were arbitrary and capricious.
The brief outlines how the appellate court substituted its own views for the scientific expertise of FDA's drug approval process.
The brief asks the court to grant a writ of certiorari, permitting review of the Fifth Circuit's ruling by SCOTUS.
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BIO Files Amicus Brief in Continuing Effort to Preserve FDA’s Expert, Scientific Authority on Drug Approvals