FOR IMMEDIATE RELEASE:
May 18, 2021
Contact: Press@paul.senate.gov, 202-224-4343
WASHINGTON, D.C. – Today, U.S. Senator Rand Paul (R-KY) reintroduced the Verified Innovative Testing in American Laboratories (VITAL) Act to help make tests quickly and widely available in health emergencies by removing unnecessary government barriers that have drastically slowed the response to the novel coronavirus pandemic. Dr. Paul’s plan would help ensure labs could develop and use tests within days, providing a better opportunity to isolate, contain, and understand viruses. This legislation is supported by the Association for Molecular Pathology (AMP).
“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. With all of the debates about how government should respond, here’s one thing it can stop doing: piling counter-productive bureaucratic hurdles in the way of our medical professionals,” said Dr. Paul.
“We are pleased that Senator Paul introduced legislation that will provide clinical laboratories with clarity and predictability in the federal oversight of laboratory developed testing procedures,” said Mary Steele Williams, MNA, MT(ASCP)SM, AMP Executive Director. “Passage of the VITAL Act is an important first step to achieving our goal of protecting patient access to potentially life-saving procedures during public health emergencies and beyond.”
Lab-developed testing procedures (LDPs), which are developed, validated, and performed inside the same laboratory, are regulated under the Clinical Laboratory Improvement Amendments (CLIA). When the COVID-19 public health emergency was declared, the government initially required all tests for the coronavirus to obtain an emergency use authorization (EUA) from the Food and Drug Administration (FDA) before they could be used on patients.
The FDA issued the Centers for Disease Control and Prevention (CDC) an EUA for its test kit on February 4, 2020, authorizing only public health labs and Department of Defense labs to use the test. But problems with the initial kit led to a weeks-long delay until the CDC issued a new one, with laboratories having to spend that critical time wrestling with bureaucratic approval in the EUA process in order to use their own tests, depleting needed resources.
While the FDA issued multiple policy changes to address the issue and speed up the process, including increasing state authority, the missed time cannot be replaced.
Dr. Paul’s plan would institute a legislative fix that allows laboratories to follow the CLIA process even during public emergencies, helping prevent such delays and waste of time and money again.
You can read Dr. Paul’s VITAL Act, HERE.