Dr. Rand Paul Introduces VITAL Act to Speed Availability of Testing in Health Emergencies

Statement

Yesterday, U.S. Senator and physician Rand Paul (R-KY) introduced S. 3512, the Verified Innovative Testing in American Laboratories (VITAL) Act of 2020, 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.

"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.

Generally, lab-developed testing procedures (LDPs), which are developed, validated, and performed inside the same laboratory, are regulated under the Clinical Laboratory Improvement Amendments (CLIA). With the January public health emergency declaration in place, however, government initially required all tests for the novel 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, 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 has 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.

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