Cathy McMorris Rodgers - the Chair of the House Energy and Commerce Committee | Official U.S. House headshot
Cathy McMorris Rodgers - the Chair of the House Energy and Commerce Committee | Official U.S. House headshot
House Energy and Commerce Committee Chair Cathy McMorris Rodgers and Subcommittee on Health Chair Brett Guthrie have announced a subcommittee hearing focusing on the regulation of diagnostic tests. The hearing, titled "Evaluating Approaches to Diagnostic Test Regulation and the Impact of the FDA’s Proposed Rule," aims to address the implications of the FDA's proposed rule on lab developed tests and alternative regulatory approaches.
In a joint statement, Chairs Rodgers and Guthrie expressed concerns about the FDA's proposed rule, highlighting the potential negative impact it could have on patients and providers. They emphasized the need for any significant changes to diagnostic test regulations to be initiated by Congress rather than the Executive Branch.
The hearing is scheduled to take place on Thursday, March 21, 2024, at 10:00 AM in the 2123 Rayburn House Office Building. Among the witnesses expected to testify are Susan Van Meter from the American Clinical Laboratory Association, Zach Rothstein from AdvaMedDx, Donald S. Karcher from the College of American Pathologists, Jeff Allen from Friends of Cancer Research, and Dara L. Aisner from the Academic Coalition for Effective Laboratory Developed Tests.
The hearing will be open to the public and press, with a live stream available online. For further information about the hearing, individuals can reach out to Emma Schultheis with the Committee staff at Emma.Schultheis@mail.house.gov. Press-related inquiries can be directed to Christopher Krepich at Christopher.Krepich@mail.house.gov.
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