On November 30, 2023, Paragon’s research paper by Dr. Joel Zinberg was referenced in Inside Health Policy‘s article “LDT Rule Must Be Finalized By May To Avoid Congressional Scrutiny.”
From the article:
A new report from Paragon Health Institute, which is headed by a former White House adviser during the Trump presidency, says FDA is not well-equipped to regulate LDTs and is overstepping its statutory authority. The report’s argument aligns with that of ACLA, claiming that FDA’s regulation over LDTs could curb innovation, and that an LDT regulatory framework must come from Congress.
“FDA’s proposed rule is ill-advised and likely exceeds the agency’s statutory authority. Adding costly and unnecessary regulations would suppress innovation of diagnostics when a flexible system, able to rapidly respond to emergencies, is needed,” the report says.
“Any change to FDA’s long-time, default practice of enforcement discretion should come from Congress, which will have to ensure that any proposal that purports to improve the regulation of LDTs actually improves public health and facilitates the development of life-saving innovation,” the report adds.
