The Association for Molecular Pathology (AMP) and the Association of Pathology Chairs (APC) congratulate U.S. Senator Rand Paul (R-KY) for introducing legislation that would allow molecular pathology professionals to continue to advance and improve offer high-quality laboratory-developed (LDP) test procedures for patient care. The Innovative Tests Verified in US Laboratories (VITAL) law of 2021 would improve transparency, preserve innovation, and ensure widespread patient access to essential medical services.
Throughout the coronavirus pandemic, the FDA imposed a regulatory process that hampered the ability of laboratories, including many academic medical centers, reference laboratories, and community health systems across the country, to develop, validate and quickly deliver high quality PDLs. on their patient populations.
The VITAL law draws attention to the important role that PDLs have played in the current response to the COVID-19 pandemic and ensures that even in the event of a public health emergency, laboratories will be allowed to work under the current regulatory system under the Clinical Laboratory Improvement Amendments (CLIA), which are administered by the Centers for Medicare and Medicaid Services (CMS). This legislation would help eliminate the redundant supervisory process by clarifying the federal regulator over PLLs and encouraging the modernization of CLIA.
The VITAL law also correctly differentiates PDLs, which are medical services developed, validated and performed within a laboratory, from packaged and shipped in vitro diagnostic test kits.
“We are pleased that Senator Paul has introduced legislation that will provide clinical laboratories with clarity and predictability in federal oversight of testing procedures.” The current coronavirus pandemic continues to highlight the inappropriateness of FDA medical device regulations for PDLs and underscore the integral role of public health. , academic and community laboratories play in the provision of patient care and public health surveillance, ”said Antonia R. Sepulveda, MD, PhD, AMP Chairman and Professor and Director of the Department of Pathology at the George Washington School of Medicine. “AMP remains committed to working with all key stakeholders to establish a more effective regulatory framework that ensures high-quality patient care while continuing to foster rapid innovation and the promise of new diagnostic technologies. the VITAL law is an important first step towards achieving this objective and protecting patients’ access to these potentially life-saving procedures. ”
This strong support from members of Congress for the VITAL Act addresses the serious consequences our nation faces when laboratory tests are regulated as medical devices.
In the early and scariest days of the pandemic, CLIA-accredited academic clinical laboratories could have used their valuable expertise and resources to expand diagnostic testing for SARS-CoV-2 in their communities, but were unable to to do so due to inappropriate FDA restrictions. Priceless weeks have been lost, making the urgency of addressing these issues even clearer. We greatly appreciate Senator Paul’s support for enabling academic labs to use their unique skills to serve patients when they need us most, and to partner with other stakeholders to create a healthier world. through innovation, education and clinical care. “
Lydia P. Howell, MD, APC President, Professor and Chair, Department of Pathology and Laboratory Medicine, University of California Davis School of Medicine