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WASHINGTON – Today, the U.S. House Energy and Commerce Subcommittee on Health held a hearing focused on evaluating approaches to diagnostic test regulation. U.S. Representative Larry Bucshon, M.D. (R-IN-08), Vice Chair of the Health Subcommittee, has been a leading voice calling for the creation of a new framework to verify the accuracy of various medical tests that doctors and patients rely on to make important health decisions. Dr. Bucshon specifically spoke on bipartisan legislation he has championed to modernize the review process for diagnostic testing, clarify the regulatory authority between the Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS), and ensure uniform standards are in place that support innovation, giving Americans the assurance they need to rely on their test results. Dr. Bucshon questioned Zach Rothstein, JD, Executive Director of AdvaMedDx. 

Dr. Bucshon’s opening remarks can be read below, in part:

“Today… is an exciting day as I’ve been working on this issue for many years, over seven years. I know it’s a complicated topic, so I want to express appreciation to my congressional colleagues who are participating here today so we can learn more about this critical issue. I would like to associate myself with the comments of many of my colleagues who have expressed displeasure at the thought of FDA regulating LDTs as medical devices. For a lot of reasons—ones that we’ve already heard and will continue to hear—these unique tools should not be evaluated in the same way that FDA reviews machines, implants, and other kinds of devices. But it’s not just LDTs that are ill-suited to be evaluated as medical devices. The entire category of invitro diagnostic tests should be differentiated from devices and provided with their own, less burdensome pathway for review and approval. Congress needs to act.”

“That’s the idea behind the VALID Act, which Congressman DeGette and I have… been working on for over seven years. While the VALID Act—like the LDT rule—assumes that diagnostics regulation is in need of change, it takes a much different approach. First of all, there is a grandfathering clause in VALID which is really important. VALID creates a new pathway for FDA approval of in vitro diagnostics, including LDTs. Under its framework, tests would be categorized as low-, medium-, or high-risk, and treated in a manner that is appropriate for each risk level. For example, low risk tests could bypass FDA’s premarket approval process altogether, and even most medium risk tests could obtain a technology certification that would allow them to immediately enter the market. Under VALID, high-risk tests—while generally subject to FDA approval—would be exempted if developed for specific individuals or small groups of people. This would allow, for example, a hospital to offer a highly sensitive toxicology test to a toddler presenting with seizures and altered mental state, to accurately identify potential substances consumed. The VALID Act is complex, so I’ll spare you further details at this time. Just know that it is a carefully developed, well-vetted piece of legislation… that many experts and stakeholders weighed in on. In fact, many of our witnesses and their organizations worked constructively… to provide feedback on VALID, and I am grateful to them.”

BACKGROUND

Americans rely every day on in vitro clinical tests (IVCTs) to diagnose diseases and conditions. These tests use human samples, such as blood or tissue, to gain insight into the best path for patient care. Innovation in the diagnostic field is occurring at a rapid pace, and holds great promise in improving health care for Americans. While diagnostic tests are a critical piece of the ability to make health care decisions, unclear regulation of these medical products creates uncertainty for the future of innovation and can create confusion among patient care teams.

The Food and Drug Administration (FDA) does not currently have a review process in place specific to diagnostic tests. IVCTs that do pursue FDA approval are reviewed under broader medical device authorities. Other IVCTs—specifically, Laboratory Developed Tests—are not required to undergo review for clinical/analytical validity.

Labs responsible for developing LDTs are subject to the regulatory authority of the Centers for Medicare & Medicaid Services (CMS) pursuant to the Clinical Laboratory Improvement Amendments of 1988 (CLIA). Under CLIA, lab operations and procedures are overseen and inspected; however, individual tests themselves are not reviewed to ensure they are yielding effective results. 

VALID Act

In March 2023, Dr. Bucshon and Rep. Diana DeGette (D-CO-01) introduced bipartisan legislation that would create a new framework to verify the accuracy of various medical tests that doctors and patients rely on to make important health decisions. 

The legislation – known as the Verifying Accurate, Leading-edge IVCT Development, or VALID, Act – would modernize the review process for diagnostic testing, clarify the regulatory authority between the Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS), and limit duplication between the two agencies by ensuring uniform standards are in place that support innovation, giving Americans the assurance they need to rely on their test results.

The VALID Act establishes a comprehensive framework for oversight of IVCTs. Under this framework, FDA would review the design of diagnostic tests to ensure doctors and patients are obtaining accurate, reliable results. Access to existing diagnostics will be maintained, as the bill grandfathers in tests already in use. Duplication of CLIA is avoided by focusing exclusively on the quality of the test itself, not the setting in which it is created or performed. 

Ultimately, the VALID Act aims to protect patients and to accelerate innovation by: 

• Establishing a risk-based framework focusing FDA resources on cutting-edge diagnostics. Under VALID, FDA would prioritize its regulatory efforts based on the level of risk and benefit to patients, a streamlined technology certification pathway, exemptions for certain lower-risk tests, and review of test modifications that could expose patients to serious harm. 
• Building on the success of breakthrough designations at FDA. This bill establishes a program to expedite development of IVCTs that address unmet needs for patients, like those with rare diseases, building on the successful breakthrough designations for medical devices and drugs. 
• Balancing the pace of innovation with regulatory reform. This bill establishes a new type of process by which IVCT developers can receive a certification for certain tests so that FDA does not have to repeatedly review tests using approved technology. 
• Improving transparency and understanding of the IVCT market in the long-term. This bill will increase understanding of the current landscape of diagnostic tests available to Americans, by providing public information on the types of tests available, labeling, post- market monitoring and reporting, and quality and design requirements. 

The VALID Act is the product of years of work by Congress, the FDA, and a wide range of stakeholders including patients, researchers, and labs that would be impacted by FDA’s rule or by the new structure that would be created by VALID. The legislation very narrowly missed being included in the 2022 end-of-year. About 10 months later, FDA promulgated a rule on LDTs.

Congressman Larry Bucshon, M.D. represents Indiana’s 8^th Congressional District in the United States House of Representatives and is a senior member of the House Energy and Commerce Committee.

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