Filed: January 30, 2024

Court: U.S. Supreme Court

Overview: Amicus brief arguing that it is not the role of courts to substitute their evaluation of drug safety and effectiveness in place of the FDA’s expert determinations.

Excerpt: “The Fifth Circuit’s substituting its evaluation of drug safety and effectiveness for FDA’s expert determinations affects far more than the modifications to the conditions of use for the single drug at issue here. Patients and their providers depend on FDA’s determinations about safety and effectiveness and expect drugs to be available according to the terms of the FDA approval, including supplemental approval. Providers rely on FDA’s expertise-based approval of drug uses in making treatment plans, and patients depend on being able to take the drugs as prescribed by their providers. The Fifth Circuit’s ruling broadly jeopardizes the reliability of FDA’s original approvals of drugs, and the agency’s approvals of modifications to the conditions of their use. It is effectively a roadmap for other litigants seeking to overturn drug approvals or conditions of use they disfavor—whether those changes expand (as was the case here) or restrict how the drug can be used. If approved drugs or modifications to conditions of use can be so readily enjoined despite FDA’s scientific assessments, the resulting uncertainty would jeopardize patient access to drugs, particularly in cases where FDA has expanded the approved uses of a drug to cover new diseases or conditions. It could also threaten patient safety, as FDA approves modifications to conditions of use where it determines they are needed to protect patients from risks of harm. Finally, the Fifth Circuit’s decision would impair the development of new treatments, as uncertainty disincentivizes pharmaceutical manufacturers, clinicians, and patients from undertaking time-and resource-intensive clinical trials to study new drugs and new indications for approved drugs.”

Case Documents:

FDA v. Alliance for Hippocratic Medicine Amicus Brief

Press Release:

Leukemia & Lymphoma Society: 25 Patient and Provider Groups Urge Supreme Court to Preserve FDA Authority