WASHINGTON, D.C. – Today, Congressman Brad Finstad (MN-01) and Congressman Dan Crenshaw (TX-02) introduced the Freedom for Laboratory Innovation and Testing Act, legislation that would prevent any federal funding from being used to implement the Biden Administration’s burdensome Food and Drug Administration’s (FDA) rule that inhibits the innovation of and delays access to Laboratory Developed Tests (LDTs).

In addition to introducing this legislation, Representatives Finstad and Crenshaw sent a letter to U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr., urging the FDA to revoke this burdensome rule.

"In southern Minnesota, patients rely on accessibility to lifesaving tests at local medical centers, where they can receive essential care close to home," said Rep. Finstad. "The FDA's final rule, if enacted, would severely limit access to critical diagnostic tests, causing delays in patient care and putting lives at risk. Additionally, this rule would impose unnecessary regulations that stifle innovation in diagnostic testing. The Freedom for Laboratory Innovation and Testing Act would protect patients and rural healthcare providers from the effects of this harmful rule and allow the Trump Administration the time needed to address this issue.” 

Background:

In May of 2024, Congressman Finstad introduced a resolution under the Congressional Review Act (CRA) to repeal the Medical Devices: Laboratory Developed Tests (LDTs), a rule that was finalized by the FDA on May 6, 2024.

Oftentimes LDTs are 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:

• Impose regulatory burdens that hinder the development and deployment of new and improved lab-developed tests;
• Increase regulatory requirements that will lead to delays in patients’ access to critical diagnostic tests;
• Potentially hinder collaborative efforts in clinical care that rely on the flexibility provided by LDTs; and,
• Negatively impact small and medium-sized laboratories, which will face economic challenges with complying with the rule as written.

Supporting Organizations: The Association for Molecular Pathology, The Association for Diagnostics and Laboratory Medicine, Telos PGX, Association for the Advancement of Blood Biotherapies, Genomind Inc, nuCARE Medical Solutions, the Academic Coalition for Effective Laboratory Developed Tests, the Association for Academic Pathology, Accu Reference Medical Laboratory, the Clinical Immunology Society, Children's Hospital of Philadelphia, American Society for Clinical Pathology, Department of Pathology and Laboratory Medicine at Children's Minnesota, City of Hope, and the Translational Genomics Research Institute.