Weekly Policy Blog: CBSA Strongly Urges Congress to Enact Legislation to Modernize Diagnostic Testing

For years, Congress has been urged by a growing coalition of state life sciences associations, patient groups, and other stakeholders, to enact legislation that will modernize the Food & Drug Administration’s (FDA) regulation of diagnostic tests, giving the agency the authority, the framework and the resources to balance proper oversight with advancement of innovation.  Colorado BioScience Association (CBSA) and our national partners continue to strongly advocate for a flexible, risk-based regulatory system that ensures timely patient access to accurate and reliable cutting-edge diagnostic technologies.   

Despite headwinds during the last Congress when important riders including the Verifying Accurate Leading-Edge In Vitro Clinical Tests (IVCTs) Development (VALID) Act were left out of the final package to reauthorize FDA User Fee Programs, lawmakers are pushing again for creation of a program to modernize FDA regulation of diagnostic tests. The VALID Act of 2023, bipartisan legislation introduced by Reps. Larry Bucshon (IN-08) and Diana DeGette (CO-01) in March, is another opportunity for Congress to act on comprehensive diagnostic regulatory reform in 2023.      

The Issue 

Diagnostic tests for clinical use, including both Laboratory Developed Tests (LDTs) and In Vitro Diagnostics (IVDs), are used to inform 70% of all health care decision making. However,  current oversight of the development and quality of these tests is outdated and fragmented. Lagging behind scientific advances and the increasing complexity of testing, present regulation is based not on the tests themselves, but rather on where the test is developed. 

Modernization of the regulation of all LDTs and IVDs under a single, predictable, diagnostic-specific, and risk-based regulatory framework is needed to foster innovation, embrace scientific advances, ensure consistency in development, accuracy, and reliability of all tests, and advance patient care and public health.  

CBSA Advocacy  

Improving the regulatory review and approval process and protecting patient access to health innovations are longstanding policy priorities for CBSA. The current federal approach to oversight of diagnostic testing has fueled regulatory uncertainty that jeopardizes investment in the next generation of cutting-edge diagnostic technologies.  

During the last Congress, CBSA and several state life sciences associations, patient groups and other stakeholders signed on to a support letter led by AdvaMed to Chairman Pallone, Chair Murray, and Ranking Members Rogers and Burr. The letter  reinforced CBSA’s and the industry’s commitment to ensuring patient access to accurate and reliable in vitro diagnostics.  

For years, CBSA has advocated for support of and recommended meaningful improvements to the VALID Act, which addresses a longstanding issue recognized by administrations of both parties. The VALID Act of 2023 is a major milestone toward modernizing the regulation of diagnostic tests and reflects years of continuous engagement and thoughtful collaboration among committee members, congressional leaders, and the stakeholder community.   

Under this new, modernized framework, the unique characteristics of diagnostic tests are differentiated from medical devices. Hospitals and laboratories can submit their technologies for electronic review, and diagnostics developed to address an unmet medical need can be expedited, speeding high-quality, reliable, and innovative tests to providers and patients, while providing the FDA with tools to administer effective oversight of these tests.  

Congress taking action to advance this legislation is vital to assuring that patients and providers have clinically accurate and reliable test results to make important health care decisions that save and change lives.    

CBSA applauds Colorado Congresswoman Diana DeGette for her tireless leadership in working with key stakeholders to shape and champion this important legislation. CBSA urges additional members of the Colorado delegation to sign-on as co-sponsors to The VALID Act of 2023. 

Categories: CBSA News