Placeholder Banner

BIO JOINS AMICUS BRIEF CHALLENGING COURT’S EFFORTS TO UNDERMINE FDA’S AUTHORITY TO BRING TREATMENTS AND CURES TO PATIENTS

April 11, 2023

The Biotechnology Innovation Organization (BIO) today signed onto an amicus brief to challenge a District Court’s unprecedented ruling (related to a single drug known as mifepristone) that would create regulatory barriers and potentially upend FDA’s authority to approve life-saving and life-enhancing therapies to patients.

The amicus brief, which was filed in the U.S. Court of Appeals for the Fifth Circuit, asks the court to suspend the District Court’s ruling until the appeal can be heard. BIO’s executive committee unanimously agreed to have BIO sign onto this amicus brief.

Related Resources
2023-04-11-amicus-brief.pdf
Discover More
BIO filed an amicus brief in the Supreme Court of the State of Delaware, urging the Court to exclude Plaintiffs’ expert opinion, thereby ensuring that Delaware’s standard for the admission of such evidence remains consistent with the federal …
On February 10, 2025, BIO filed an amicus brief in the U.S. District Court for the District of Columbia, supporting the lawfulness of plaintiff Eli Lilly's proposed 340B rebate model. The 340B Drug Pricing Program ("340B"), through which Medicaid…
BIO filed an amicus brief in the U.S. Court of Appeals for the Federal Circuit urging rehearing of a case involving whether certain Teva Pharmaceuticals patents had been properly listed in FDA’s Orange Book (Approved Drug Products with Therapeutic…