Rep. Congressman Dan Crenshaw | Twitter
Rep. Congressman Dan Crenshaw | Twitter
Congressman Dan Crenshaw and Congressman Brad Finstad have introduced the Freedom for Laboratory Innovation and Testing Act. This legislation aims to prevent federal funding from being used to implement a Food and Drug Administration (FDA) rule that, according to the congressmen, hinders innovation and delays access to Laboratory Developed Tests (LDTs).
In addition to proposing this legislation, Representatives Finstad and Crenshaw have sent a letter to U.S. Department of Health and Human Services Secretary Robert F. Kennedy, Jr., urging the FDA to revoke the rule.
The FDA's rule on Medical Devices: Laboratory Developed Tests was finalized on May 6, 2024. According to Crenshaw and Finstad, LDTs are often essential within the U.S. healthcare system for providing timely results for patients with rare diseases and conditions. They argue that the implementation of this rule would impose regulatory burdens that could hinder new test development, delay patient access to diagnostic tests, potentially disrupt collaborative clinical care efforts, and economically impact small and medium-sized laboratories.
The legislation is supported by various organizations including The Association for Molecular Pathology, The Association for Diagnostics and Laboratory Medicine, Telos PGX, Genomind Inc., nuCARE Medical Solutions, Texas Children's Hospital, Children's Hospital of Philadelphia, among others.
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