The House Energy and Commerce Health Subcommittee held a March 21 hearing entitled “Evaluating Approaches to Diagnostic Test Regulation and the Impact of the FDA’s Proposed Rule.” The hearing explored the U.S. Food and Drug Administration’s (FDA’s) proposed regulation of laboratory developed tests (LDTs) as well as the Verifying Accurate Leading-edge IVCT Development (VALID) Act (H.R. 2389), which would mandate the FDA regulate in vitro clinical tests (IVTs) and define detailed provisions for premarket approval, exemption criteria, and regulatory oversight of these tests.
Members of the committee asked questions to better understand the current realm of patient safety with LDTs, potential for overly strict regulations that could stifle medical innovation, and potential impact on patient access to care and up-to-date medical technology. The AAMC previously submitted a comment letter to the FDA regarding their proposed rules on LDTs [refer to Washington Highlights Dec. 8, 2023]. Witnesses included Dara Aisner, MD, PhD, medical director of the Colorado Molecular Correlates Laboratory, professor of pathology at the University of Colorado, and representative of the Academic Coalition for Effective Laboratory Developed Tests, and Donald Karcher, MD, president of the College of American Pathologists.