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 on Medical Devices: Laboratory Developed Tests (LDTs). The final rule, published on May 6th, aims to impose new regulations on the creation and implementation of LDTs, which could limit patients' access to critical diagnostic testing. According to Dr. Paul, these tests are already regulated by the Centers for Medicare & Medicaid Services, and Congress has not authorized the FDA to regulate lab tests.

U.S. Congressman Brad Finstad (MN-01) introduced a similar resolution in the U.S. House of Representatives. Lab-developed tests are often essential within the U.S. healthcare system for providing timely results to patients with rare diseases and conditions.

The implementation of the FDA’s rule is expected to:

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

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

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

- Limit test offerings due to economic burdens potentially forcing 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.”