Washington, D.C. — House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA) and Subcommittee on Health Chair Brett Guthrie (R-KY) today announced a subcommittee hearing titled "Evaluating Approaches to Diagnostic Test Regulation and the Impact of the FDA’s Proposed Rule."

“Patients and providers increasingly rely on the results of diagnostics to detect, guide treatment decisions, and monitor a host of medical conditions and illnesses. The FDA has proposed a rule that relies upon dubious and misguided legal, economic, and public health arguments and has provided limited opportunities for stakeholders to offer input. The proposed rule extends far beyond the scope of any legislative proposals and would threaten access to reliable tests for children and patients with rare diseases. Any paradigm-shifting changes to the current regulations must come from Congress—not the Executive Branch,” said Chair Rodgers and Guthrie. 

Subcommittee on Health hearing titled "Evaluating Approaches to Diagnostic Test Regulation and the Impact of FDA’s Proposed Rule." 

WHAT: A hearing to discuss the FDA’s proposed rule to regulate lab developed tests and alternative approaches to diagnostic regulation. 

DATE: Thursday, March 21, 2024   

TIME: 10:00 AM   

LOCATION: 2123 Rayburn House Office Building   

WITNESSES: 

• Susan Van Meter, President, American Clinical Laboratory Association (ACLA)  
• Zach Rothstein, JD, Executive Director, AdvaMedDx  
• Donald S. Karcher, MD, FCAP, President of the College of American Pathologists (CAP) 
• Jeff Allen, PhD, President and CEO, Friends of Cancer Research   
• Dara L. Aisner, MD, PhD, Medical Director, Colorado Molecular Correlates Laboratory, Professor of Pathology, University of Colorado; Representative of the Academic Coalition for Effective Laboratory Developed Tests 

This notice is at the direction of the Chair. The hearing will be open to the public and press and will be live streamed online at https://energycommerce.house.gov/. If you have any questions concerning the hearing, please contact Emma Schultheis with the Committee staff at Emma.Schultheis@mail.house.gov. If you have any press-related questions, please contact Christopher Krepich at Christopher.Krepich@mail.house.gov.