Opinion: VITAL Act would remove red tape from labs creating diagnostic tests

U.S. Senator

Thursday, March 18, 2020 — As a physician, I understand the need for an “all hands on deck” response from our medical community to the Novel Coronavirus pandemic. That means speedy access to diagnostic testing and medical supplies, and, most importantly, it means preparedness to care for every Kentuckian in need.


As your senator, I am committed to doing whatever I can to ensure big government doesn’t stand in the way of that care.

When we face a health emergency, government should trust community, academic, 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, perhaps it ought to consider this Kentucky physician’s prescription: remove the counterproductive, bureaucratic roadblocks that are standing in the way of our medical professionals and limiting access to diagnostic testing, medical care, and necessary equipment.

The unnecessary red tape that endlessly zigs and zags its way through all our federal agencies isn’t just a nuisance I’ll rail against on the Senate floor. It is actually a threat to human lives. Just ask Dr. Alex Greninger, a Washington state lab expert and epidemiologist who has been mired in bureaucratic delays trying to get his coronavirus diagnostic test approved. 

On February 28, he and other laboratorians sent a letter to Congress explaining that clinical labs across the country had working tests ready to use, but all their work was for naught because the test developed by the Centers for Disease Control and Prevention (CDC) was the only one the Food and Drug Administration (FDA) would authorize.

Thankfully, the FDA ultimately reversed itself and loosened its restrictions, but I have now introduced a bill to prevent this from ever happening again.

This week, I introduced the Verified Innovative Testing in American Laboratories (VITAL) Act of 2020, which will help make tests quickly and widely available in this emergency (and all health emergencies) by removing unnecessary government barriers that have drastically slowed response efforts. My plan would help ensure labs could develop and use tests within days, providing a better opportunity to isolate, contain, and understand viruses.

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 FDA before they could be used on patients. 

The FDA issued the 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, 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. 

The CDC did not provide a new test kit until the end of February. While the FDA eventually announced some policy changes to address the issue and speed up the process, including by increasing state authority, the missed time cannot be replaced. My plan would institute a legislative fix that allows laboratories to follow the CLIA process even during public emergencies, helping to prevent wasting so much time and money again.

I’ve also cosponsored legislation to addresses the shortage of critically important protective breathing masks for medical personnel. The Health Care Workforce Protection Act of 2020 extends current limited liability protections to help guarantee the availability of masks as government, businesses, and local communities respond to the Novel Coronavirus.  It ensures that more certified breathing masks, often called respirators, are classified as a “covered countermeasure” in times of a declared public health emergency, making them eligible for the same federal liability protections as qualified pandemic or epidemic products.

Under current law, the Department of Health and Human Services (HHS) is able to grant limited liability protection to manufacturers and distributors of certain medical items to encourage more production. Many of these masks, which protect against respiratory illnesses, lack this liability protection, so suppliers are hesitant to ramp up production.

Last week, President Trump issued an executive order requiring more masks to be made available.  This bill would support that order and ensure it makes the maximum possible impact.

A seven-week delay for testing kits must not happen again. A shortage of breathing masks must not happen again. And these things don’t have to happen again. We need permanent fixes to ensure the medical community can safely and swiftly respond to health emergencies. I encourage my fellow members of Congress to join me in standing up for our medical community, and I look forward to their support of both the VITAL Act and the Health Care Workforce Protection Act in the Senate.


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