CEI Issues Amicus Brief in American Clinical Laboratory Association v. Food and Drug Administration

INTEREST OF AMICUS CURIAE

Competitive Enterprise Institute (“Amicus”) is a nonprofit organization headquartered in Washington, D.C., dedicated to promoting the principles of free markets and limited government. Since its founding in 1984, the institute has focused on raising public understanding of the problems of overregulation. It has done so through policy analysis, commentary, and litigation.

INTRODUCTION

Plaintiffs in these consolidated cases have petitioned this Court to vacate a rule (“the Final Rule”) that the U.S. Food and Drug Administration (“FDA”) adopted with regard to medical devices and laboratory developed tests. Medical Devices; Laboratory Developed Tests, 89 Fed. Reg. 37,286 (May 6, 2024) (to be codified at 21 C.F.R. § 809.3(a)). Plaintiffs moved for summary judgment in their favor. See Dkt. #20, 27. Amicus respectfully submits this brief in support of the motions for summary judgment to suggest to the Court that the Final Rule is incompatible with the statutory text and its context, both in what it retains and in what it adds, and that particularly with regard to the announced phaseout policy, FDA has not exercised its authority consistently with the requirements of the Administrative Procedure Act.