The Association for Molecular Pathology (AMP) applauds US Senator Rand Paul (R-Ky) for introducing new legislation to allow molecular pathology professionals to continue advancing and offering laboratory-developed testing procedures (LDPs) for patient care. The proposed legislation, called the Verified Innovative Testing in American Laboratories (VITAL) Act of 2020 clarifies federal regulatory authority over LDPs and encourages modernization of the existing Clinical Laboratory Improvement Amendments (CLIA), which are administered by the Centers for Medicare and Medicaid Services. The legislation was designed to enhance transparency, preserve innovation, and ensure widespread patient access to essential medical services. “When we face a health emergency, government should trust academic, community, and public health labs to do what they are already trained and certified to do,” said Senator Paul, in a statement from his office. “With all of the debates about how government should respond, here’s one thing it can stop doing: piling counterproductive bureaucratic hurdles in the way of our medical professionals.” According to AMP, the current coronavirus pandemic highlights the inefficiency of FDA oversight processes and, at the same time, underscores the integral role that public health, local academic, and community laboratories play to both patient care and public health surveillance. The public health emergency declaration retroactive to January 27, 2020, triggered a requirement that all tests for SARS-CoV-2, regardless of whether they are boxed and shipped testing kits or medical procedures, obtain emergency use authorization from FDA prior to use. This decision, since modified, prevented many laboratories from fixing the flaw in the first test kit provided by the Centers for Disease Control and Prevention. In AMP’s view, this regulatory process imposed by the FDA was duplicative with CLIA regulations and impeded the ability of private laboratories, including many academic medical centers, reference laboratories, and community health systems across the country, to rapidly develop, validate, and offer high-quality LDPs for use on their local patient populations. “We are pleased that Senator Rand Paul introduced this legislation that will provide clinical laboratories with clarity and predictability in federal oversight of testing programs,” says Karen E. Weck, MD, president of AMP. “The delayed response to the current coronavirus pandemic perfectly illustrates the importance of clinical laboratories in being able to develop and provide novel testing services. AMP members welcome the opportunity to share our collective expertise and engage with key stakeholders to modernize the current CLIA oversight system in order to ensure high-quality testing without jeopardizing innovation or compromising patient access to potentially lifesaving procedures.” For more information, visit AMP and the office of Senator Ron Paul.