Washington DC – House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-Wash.) and Health Subcommittee Chair Brett Guthrie (R-Ky.) today announced, “The FDA's approach to diagnostic test regulation and announced the holding of a subcommittee hearing entitled “Assessing the Impact of the Proposed Rule.''
“Patients and health care providers increasingly rely on diagnostic results to detect, guide and monitor treatment decisions for many medical conditions and diseases. It proposes a rule that relies on questionable and misguided arguments, with limited opportunities for stakeholders to provide input.The proposed rule goes far beyond the scope of any legislative proposal and is rare. It threatens access to reliable testing for children and patients with the disease. Paradigm-altering changes to current regulations must come from Congress, not the executive branch.” Chairman Rogers and Mr. Guthrie said.
Health Hearing Subcommittee entitled “Approaches to Diagnostic Test Regulation and Evaluating the Impact of FDA's Proposed Rule.''
what: Public hearing to discuss FDA's proposed rule to regulate laboratory-developed tests and alternative approaches to diagnostic regulation.
date: Thursday, March 21, 2024
time: 10 am
position: 2123 Rayburn House Office Building
witness:
- susan van meter, President, American Clinical Laboratory Association (ACLA)
- Zack Rothstein, Dr., Executive Director, AdvaMedDx
- Donald S. Kercher, MD, FCAP, President, College of American Pathologists (CAP)
- Jeff Allen,PhD, President and CEO, Friends of Cancer Research, Inc.
- Dara L. Eisner, MD, Medical Director, Colorado Molecular Correlations Institute, Professor of Pathology, University of Colorado.Representative of the Academic Alliance for Effective Clinical Test Development
This notice is based on the instructions of the Chairman. The hearing will be open to the public and media and will be livestreamed online. https://energycommerce.house.gov/. If you have any questions regarding the hearing, please contact her Emma Schultheis on Committee staff. Emma.Schultheis@mail.house.gov. If you have any media-related questions, please contact Christopher Krepich. Christopher.Krepich@mail.house.gov.
