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Per usual, smarter, faster people than me already have a great synopsis up of today's LDT hearing in the House Energy & Commerce Health Subcommittee (thanks Christine P. Bump!)
A few additional key moments that I noticed:
- As Christine noted, the VALID Act was brought up a lot. Perhaps just as important, the idea of updating CLIA to address FDA's concerns received a largely cool reception from the Representatives.
- ACLA made some really good points about the deficiencies in FDA's economic impact assessment. If you haven't read their response to FDA's proposed rule, you really should (get some coffee, it's very robust). Susan Van Meter also noted that LDTs are already highly regulated, a critical point that I think gets overlooked quite often.
- I thought there was some interesting push and pull regarding the cost to patients. The healthcare costs due to inaccurate LDTs was raised, but importantly the healthcare costs should LDTs suddenly disappear and no longer be available to patients was also raised. I think the bottom line is that a balanced approach is going to be critically important on this topic.
- Rep. Burgess made a critical point that I'm extremely glad he brought up: laboratory tests are rarely used in isolation. A physician will look at the totality of information available to them in order to treat a patient. That doesn't completely remove the risk an inaccurate test result might pose, but it's definitely a mitigating factor.
- Rep. Shrier made another point I really like, addressing a concern by some that different LDTs for the same intended use may give slightly different results from one another. She noted that many tests can have different performance characteristics but still be accurate, and this is something a physician can discuss with their patient. I'd add that's why tests have reference ranges and interpretation guidance.
- Several individuals noted that we don't know how many LDTs exist. That fact makes these conversations much harder. The idea of leveraging CLIA or possibly CAP to better track LDTs was raised; it's a good thought but would be a significant effort.
- The "uneven playing field" between IVDs and LDTs was mentioned a few times. The thought that some IVD manufacturers are avoiding the market because LDTs don't need to go through the FDA is one FDA made in the proposed rule as well, but I don't find it persuasive. If there's money to be made, a commercial manufacturer would develop a test kit. The fact is, many LDTs meet testing needs that aren't financially attractive for IVD manufacturers.
- Tests for pediatric patients and rare diseases were mentioned many times, appropriately, as being at risk.
A few additional key moments that I noticed:
- As Christine noted, the VALID Act was brought up a lot. Perhaps just as important, the idea of updating CLIA to address FDA's concerns received a largely cool reception from the Representatives.
- ACLA made some really good points about the deficiencies in FDA's economic impact assessment. If you haven't read their response to FDA's proposed rule, you really should (get some coffee, it's very robust). Susan Van Meter also noted that LDTs are already highly regulated, a critical point that I think gets overlooked quite often.
- I thought there was some interesting push and pull regarding the cost to patients. The healthcare costs due to inaccurate LDTs was raised, but importantly the healthcare costs should LDTs suddenly disappear and no longer be available to patients was also raised. I think the bottom line is that a balanced approach is going to be critically important on this topic.
- Rep. Burgess made a critical point that I'm extremely glad he brought up: laboratory tests are rarely used in isolation. A physician will look at the totality of information available to them in order to treat a patient. That doesn't completely remove the risk an inaccurate test result might pose, but it's definitely a mitigating factor.
- Rep. Shrier made another point I really like, addressing a concern by some that different LDTs for the same intended use may give slightly different results from one another. She noted that many tests can have different performance characteristics but still be accurate, and this is something a physician can discuss with their patient. I'd add that's why tests have reference ranges and interpretation guidance.
- Several individuals noted that we don't know how many LDTs exist. That fact makes these conversations much harder. The idea of leveraging CLIA or possibly CAP to better track LDTs was raised; it's a good thought but would be a significant effort.
- The "uneven playing field" between IVDs and LDTs was mentioned a few times. The thought that some IVD manufacturers are avoiding the market because LDTs don't need to go through the FDA is one FDA made in the proposed rule as well, but I don't find it persuasive. If there's money to be made, a commercial manufacturer would develop a test kit. The fact is, many LDTs meet testing needs that aren't financially attractive for IVD manufacturers.
- Tests for pediatric patients and rare diseases were mentioned many times, appropriately, as being at risk.
Christine P. BumpChristine P. Bump• 2nd• 2ndRegulatory attorney who develops and implements FDA strategies for devices, diagnostics, digital health, and wellness products | Penn Avenue Law & PolicyRegulatory attorney who develops and implements FDA strategies for devices, diagnostics, digital health, and wellness products | Penn Avenue Law & Policy
1w • Edited •
The key takeaway from today’s House Subcommittee on Health hearing, “Evaluating Approaches to Diagnostic Test Regulation and the Impact of FDA’s Proposed Rule,” is that the #VALID Act is a better path forward for providing regulatory certainty for all stakeholders and balancing #LDT accuracy with innovation and access to patients, especially for pediatric patients, rare diseases, small patient populations, and rural populations.
- All five witnesses supported the VALID Act (though Susan Van Meter, President, American Clinical Laboratory Association (ACLA) and 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, explained that issues and concerns still need to be addressed).
- All five witnesses stated that their organizations would continue to work with Congress to develop an appropriate regulatory framework for all diagnostic tests.
- None of the witnesses agree that the existing medical device framework is the most appropriate or suitable means through which to assure the quality and accuracy of tests. Discussion revealed that the medical device framework is not ideal for #IVDs generally.
The hearing provided an interesting and insightful discussion with different views about the need for #FDA's review of tests to ensure accuracy and whether there is actually a “major problem that needs a solution.” Many Subcommittee members cited FDA’s proposed rule as an overreach of the agency’s authority and questioned FDA’s capacity to enforce the rule as proposed. Important discussions included the constraints on test innovation, development, and modification under the medical device framework, and the burdensome costs that will lead to a loss of access to tests and consolidation of the laboratory industry. Overall, the VALID Act was repeatedly discussed as a better alternative for all sides.
- All five witnesses supported the VALID Act (though Susan Van Meter, President, American Clinical Laboratory Association (ACLA) and 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, explained that issues and concerns still need to be addressed).
- All five witnesses stated that their organizations would continue to work with Congress to develop an appropriate regulatory framework for all diagnostic tests.
- None of the witnesses agree that the existing medical device framework is the most appropriate or suitable means through which to assure the quality and accuracy of tests. Discussion revealed that the medical device framework is not ideal for #IVDs generally.
The hearing provided an interesting and insightful discussion with different views about the need for #FDA's review of tests to ensure accuracy and whether there is actually a “major problem that needs a solution.” Many Subcommittee members cited FDA’s proposed rule as an overreach of the agency’s authority and questioned FDA’s capacity to enforce the rule as proposed. Important discussions included the constraints on test innovation, development, and modification under the medical device framework, and the burdensome costs that will lead to a loss of access to tests and consolidation of the laboratory industry. Overall, the VALID Act was repeatedly discussed as a better alternative for all sides.
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