The House Energy and Commerce Health Subcommittee held a May 22 hearing entitled “Check Up: Examining FDA Regulation of Drugs, Biologics, and Devices,” which focused on regulatory and oversight work conducted by the U.S. Food and Drug Administration (FDA) and featured witness testimony from three FDA center directors including Patrizia Cavazzoni, Md, Director of the Center for Drug Evaluation and Research, Peter Marks, MD, PhD, director of the Center for Biologics Evaluation and Research, and Jeff Shuren, MD, JD, director of the Center for Devices and Radiological Health (CDRH).
Subcommittee chair Brett Guthrie (R-Ky.) highlighted concerns related to the FDA’s recently released laboratory developed test (LDT) final rule [refer to Washington Highlights Dec. 8, 2023], stating, “The recently released, 500-page Laboratory Developed Test, or LDT, rule has been touted as a mechanism to drive more innovation and protect patient safety. I fear this complete overhaul of LDT regulation will have the opposite effect — instead driving up the costs of care and delaying patient access to life-saving care. Tests developed to treat patients at the bedside, to detect early-stage cancer, or detect Alzheimer’s sooner would be subject to onerous requirements under this new regime proposed by CDRH.”