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 recently finalized FDA rule titled "Medical Devices: Laboratory Developed Tests" (LDTs). The final rule, published on May 6th, imposes new regulations on the creation and implementation of LDTs, which are essential for providing timely diagnostic results for patients with rare diseases and conditions. Congressman Brad Finstad (MN-01) introduced a corresponding resolution in the U.S. House of Representatives.

According to Dr. Paul, these new regulations would hinder the development and deployment of lab-developed tests, delay or deprive patient access to critical diagnostics for conditions such as cancer and heart disease, impede collaborative clinical care efforts, and potentially force small and medium-sized laboratories to close due to economic burdens.

"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."

Rep. Finstad echoed these concerns: "Minnesota’s First District is home to some of the most cutting-edge medical innovation in the world. With new technologies emerging every day, diagnostic testing is more advanced than ever before, largely thanks to laboratory developed tests," he stated. "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."

The resolution aims to protect LDTs from overregulation while strengthening the relationship between medical innovation and patient care.