Friday, March 22, 2024

Resources: The 3-Hour Congressional FDA LDT Hearing on March 21, 2024

On March 21, 2024, the House Energy & Commerce committee held a 3-hour hearing on the FDA's plan to regulate LDTs.  Here are some resources, including a Zip file with all major documents.


The three hour session is online at YouTube here:

(The YouTube program notes give access to an online YT auto transcript).

The House home page for the hearing is here:

(Click on Hearing Announcement, Hearing Memo, and View Agenda).

Presentations included 

  • Susan Van Meter, President, ACLA
  • Zach Rothstein JD, AdvaMed Dx
  • Donald S. Karcher MD, President, CAP
  • Jeff ALlen PhD, President & CEO, Friends of Cancer Research
  • Dara L. Aisner MD PhD, "Academic Coalition for Effective Laboratory Tests" (academic LDTs)
An excellent rapid online summary was posted by Joe Lennerz MD PhD of BostonGene, at Linked In.

Note that Lennerz's article includes an 11-slide summary that includes each speaker's main points ("Summary of Witness Testimony").

See subscription reporting at Genomeweb here.


Here is a Chat GPT summary of the 3 adverse comments, ACLA, CAP, Acad LDTs:

Here is a Chat GPT summary of the 2 favorable comments, FOCR, AdvaMed:



Find a Google doc with an Auto-summary and next, the 60-page full Auto-transcript here:

Direct  shared access to auto transcript here:



I have included a ZIP file with all FDALDT testimony and reference documents, plus a 62 page auto summary and auto transcript.  Open access to the ZIP file here:

AI CORNER - Summary of "Both Opening Remarks"

Summary of Opening Remarks

Subcommittee Chair Guthrie's Opening Remarks on the Regulation of Diagnostic Tests

Subcommittee Chair Brett Guthrie opened the hearing by addressing concerns over the FDA's proposed rule to regulate laboratory developed tests (LDTs) as medical devices, potentially impacting access to reliable diagnostic tests for children and patients with rare diseases. He outlined the historical context of diagnostic test regulation, highlighting the split oversight between the FDA and the Centers for Medicare and Medicaid Services, and the 1988 Clinical Laboratory Improvement Amendments (CLIA) which aimed at ensuring test accuracy and reliability.

Guthrie emphasized the significance of LDTs in various medical and public health applications, including cancer treatment and drug trafficking monitoring. He criticized the FDA's attempts to reform LDT regulation, arguing that the proposed rule would limit labs' flexibility to modify tests, potentially leading to higher costs and stifling innovation without necessarily enhancing patient protection. He expressed concern over the rule's unintended consequences, such as increased consolidation among testing providers and adverse impacts on personalized medicine and disadvantaged populations. Guthrie called for Congressional engagement with the public health community to address diagnostic testing challenges without compromising innovation.

Chair Rodgers's Opening Remarks on the Regulation of Diagnostic Tests

Chair Cathy McMorris Rodgers critiqued the FDA's proposed rule on LDT regulation for potentially stifling biomedical innovation and delaying patient care. She stressed the importance of LDTs, especially for rare diseases and certain cancers, and voiced concerns over the rule's impact on laboratory operations and costs. Rodgers detailed the burdensome nature of the proposed regulations, predicting significant financial strain on labs and restricted access to tests for vulnerable populations.

She contrasted the FDA's estimate of the number of LDTs affected by the rule with the agency's capacity to review premarket submissions, suggesting the rule would lead to fewer diagnoses, higher costs, and delays in care. Rodgers called for a reevaluation of the rule and expressed interest in exploring legislative alternatives to the proposed regulatory approach, emphasizing the need to maintain America's leadership in biomedical innovation and ensure timely patient access to necessary diagnostic tests.