Dr. Paul, Rep. Finstad Introduce Resolution to Repeal Harmful FDA Rule Limiting Access to Laboratory Developed Tests

– On Wednesday, U.S. Senator Rand Paul (R-KY) introduced a resolution under the Congressional Review Act (CRA) to repeal Medical Devices: Laboratory Developed Tests (LDTs), a rule that was recently finalized by the Food and Drug Administration (FDA). The final rule, published May 6th, seeks to impose burdensome regulations on the creation and implementation of laboratory developed tests (LDTs), limiting patients’ access to critical diagnostic testing. Additionally, these tests are already regulated by the Centers for Medicare & Medicaid Services and Congress has never given the FDA the authority to regulate lab tests. U.S. Congressman Brad Finstad (MN-01) introduced the resolution in the U.S. House of Representatives today.

Lab tests are often the only or most reliable option available within the U.S. healthcare system that provide timely results to patients with rare diseases and conditions. Specifically, implementation of FDA’s rule would:

  • Hinder the development and deployment of new and improved lab-developed tests.
  • Delay or deprive patient access to tests that diagnose or indicate whether a patient is genetically predisposed to cancer, heart disease, and other conditions.
  • Impede collaborative efforts in clinical care that rely on the flexibility provided by lab tests; and,
  • Limit the test offerings made available to patients because the economic burden imposed by the rule made 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.”