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" (LDTs) rule recently finalized by the Food and Drug Administration (FDA). The final rule, published on May 6th, aims to impose regulations on the creation and implementation of laboratory-developed tests, potentially limiting patient access to critical diagnostic testing. Congressman Brad Finstad (MN-01) introduced the same resolution in the U.S. House of Representatives.

Laboratory-developed tests are often crucial for providing timely results for patients with rare diseases and conditions within the U.S. healthcare system. According to critics, implementing the FDA’s rule would:

- Hinder the development and deployment of new lab-developed tests.

- Delay or deprive patient access to tests that diagnose or indicate genetic predispositions to conditions such as cancer and heart disease.

- Impede collaborative clinical care efforts that rely on lab test flexibility.

- Limit available test offerings due to economic burdens that could 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 new testing methods' development, delay access to patient care, and impact many laboratories 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."

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