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). This final rule, published on May 6th, aims to impose new regulations on LDTs, which could limit patient access to essential diagnostic tests. Congressman Brad Finstad (MN-01) introduced a similar resolution in the U.S. House of Representatives.

The proposed FDA rule has raised concerns that it would hinder the development and deployment of new lab-developed tests and delay or prevent patient access to critical diagnostics for conditions such as cancer and heart disease. Critics argue that these tests are already regulated by the Centers for Medicare & Medicaid Services and that Congress has not granted the FDA authority over lab tests.

Dr. Paul criticized the FDA's actions: "This is yet another brazen power grab by the FDA under the direction of President Biden," he said. "Unnecessary regulations on lab developed tests threaten to delay critical diagnostics and undermine healthcare innovation."

Rep. Finstad echoed these sentiments, emphasizing the importance of LDTs in medical innovation: "Minnesota’s First District is home to some of the most cutting-edge medical innovation in the world," 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."

Both legislators underscored their commitment to preserving LDTs' role in advancing medical technology and ensuring patient health.