On January 8, 2024, Paragon’s Joel Zinberg, and his recent research Unwise and Unauthorized: FDA Regulation of Laboratory Developed Tests, were referenced in the Heartland Daily News article “FDA Wants to Expand Authority to Include Lab Developed Tests.”
From the article:
The FDA’s proposal would amend agency regulations to make explicit that IVDs are medical devices, including when the manufacturer is a laboratory.
“The Proposed Rule, at least in part, is likely intended to prod Congress to enact legislation explicitly giving FDA authority to regulate LDTs as medical devices,” said Joel Zinberg, M.D., J.D., a senior fellow at the Competitive Enterprise Institute and director of the Public Health and American Well Being Initiative at the Paragon Health Institute, which published an analysis of the FDA’s proposal in a paper, “Unwise and Unauthorized: FDA Regulation of Laboratory Developed Tests.”
The Center for Science in the Public Interest, AdvaMed, and others support the FDA’s effort.
Other players, including the American Hospital Association, National Independent Laboratory Association (NILA), and American Clinical Laboratory Association (ACLA), are opposed.
“FDA must overcome the fact that the FDCA doesn’t mention laboratories, laboratory services or LDTs and has many sections that appear contrary to FDA’s claim of regulatory authority,” Zinberg told Health Care News. Zinberg’s paper cites court decisions in Brown & Williamson Tobacco Corporation and West Virginia v. Environmental Protection Agency, for the premise that courts will not assume agency authority if the statute is silent.
