Bowling Green Today

On May 17, 2024, U.S. Senator Rand Paul (R-KY) introduced a resolution under the Congressional Review Act (CRA) to repeal the "Medical Devices: Laboratory Developed Tests" rule recently finalized by the Food and Drug Administration (FDA). The final rule, published on May 6th, seeks to impose regulations on laboratory developed tests (LDTs), potentially limiting patients' access to critical diagnostic testing. Congressman Brad Finstad (MN-01) introduced a corresponding resolution in the U.S. House of Representatives.

Laboratory developed tests are often essential within the U.S. healthcare system for providing timely results to patients with rare diseases and conditions. Implementation of the FDA’s rule would hinder the development and deployment of new lab-developed tests, delay or deprive patient access to diagnostics for genetic predispositions to conditions such as cancer and heart disease, impede collaborative clinical care efforts, and limit test offerings due to economic burdens that may force small and medium-sized laboratories to close.

“This is yet another brazen power grab by the FDA under the direction of President Biden,” said Dr. Paul. “Unnecessary regulations on lab developed tests threaten to delay critical diagnostics and undermine healthcare innovation. This CRA is a step towards preserving the innovation and flexibility needed to address emerging medical challenges and safeguard patient health.”

“Minnesota’s First District is home to some of the most cutting-edge medical innovation in the world," said Rep. Finstad. "With new technologies emerging every day, diagnostic testing is more advanced than ever before, largely thanks to laboratory developed tests. This harmful rule from FDA will stifle the development of new methods of testing, delay access to patient care, and impact many of the laboratories that we depend on in southern Minnesota for accurate, timely diagnostic testing. I am proud to introduce this resolution with Rep. Crenshaw to protect LDTs from overregulation and strengthen the relationship between medical innovation and patient care.”