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 rule by the Food and Drug Administration (FDA) concerning Medical Devices: Laboratory Developed Tests (LDTs). This final rule, published on May 6th, aims to impose regulations on the creation and implementation of LDTs, potentially limiting patient access to critical diagnostic testing. U.S. Congressman Brad Finstad (MN-01) introduced a corresponding resolution in the U.S. House of Representatives.

Lab tests often provide timely results for patients with rare diseases and conditions within the U.S. healthcare system. The FDA's new rule could hinder the development and deployment of these tests, delay or deprive patient access to diagnostics for genetic predispositions to cancer, heart disease, and other conditions, impede collaborative clinical care efforts that rely on lab test flexibility, and limit test offerings due to economic burdens that may 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. With new technologies emerging every day, diagnostic testing is more advanced than ever before, largely thanks to laboratory developed tests," said Rep. Finstad. "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."

###