Bowling Green Today

On Wednesday, U.S. Senator Rand Paul (R-KY) and U.S. Congressman Brad Finstad (MN-01) introduced a resolution under the Congressional Review Act (CRA) to repeal a rule recently finalized by the Food and Drug Administration (FDA). The rule, titled "Medical Devices: Laboratory Developed Tests" (LDTs), was published on May 6th and seeks to impose regulations on the creation and implementation of laboratory developed tests (LDTs). These regulations are perceived as burdensome, potentially limiting patients' access to critical diagnostic testing.

The FDA's final rule has been criticized for duplicating existing regulations. LDTs are already regulated by the Centers for Medicare & Medicaid Services, and Congress has not granted the FDA authority to regulate lab tests. Critics argue that this redundancy may limit patients' access to vital diagnostic tools.

Laboratory tests often provide the only or most reliable option for timely results for patients with rare diseases and conditions within the U.S. healthcare system. The implementation of the FDA's rule could hinder the development and deployment of new and improved lab-developed tests, delay or deprive patient access to tests that diagnose or indicate genetic predisposition to diseases such as cancer and heart disease, impede collaborative efforts in clinical care relying on lab test flexibility, and limit test offerings due to economic burdens imposed by the rule.

Dr. Paul expressed his concerns about this issue: “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. This CRA is a step towards preserving the innovation and flexibility needed to address emerging medical challenges and safeguard patient health.”

Rep. Finstad echoed these sentiments: “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,” he said. “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.”