Bowling Green Today

U.S. Senator Rand Paul (R-KY) has introduced a resolution under the Congressional Review Act (CRA) to repeal the recently finalized rule by the Food and Drug Administration (FDA) concerning Medical Devices: Laboratory Developed Tests (LDTs). The final rule, published on May 6th, aims to impose new regulations on LDTs, which could limit patients' access to essential diagnostic testing. Congressman Brad Finstad (MN-01) introduced a corresponding resolution in the U.S. House of Representatives.

The FDA's rule is intended to regulate the creation and implementation of LDTs, which are already overseen by the Centers for Medicare & Medicaid Services. Critics argue that Congress has not granted the FDA authority over lab tests. Lab tests are crucial within the U.S. healthcare system for providing timely results to patients with rare diseases and conditions.

Implementation of this rule could hinder the development and deployment of new 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 economically burden small and medium-sized laboratories.

"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," stated 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."