HENRICO, V.A. – To improve federal coordination of coronavirus testing, U.S. Representative Abigail Spanberger today introduced bipartisan legislation to require a comprehensive investigation into the development, regulation, and deployment of COVID-19 diagnostic tests since the pandemic began.

The race to distribute millions of COVID-19 test kits to healthcare providers and local governments has raised concerns about the accuracy and quality of these tests. Under the current policy established by the U.S. Food and Drug Administration (FDA), labs and manufacturers are allowed to market and sell tests with very little oversight of the tests’ accuracy. Under this lax policy, the FDA has issued more than 90 authorizations for the hundreds of tests that labs and manufacturers have brought to market, meaning the majority of these tests have not received any review by the FDA. The resulting high levels of confusion about these tests’ accuracy and reliability could hinder decision-making around the economy and public health—particularly as the United States faces the threat of increased COVID-19 cases in the late summer and fall.

To begin addressing these concerns, Spanberger’s bill would bring greater transparency and accountability to federal testing efforts—and it would demand answers about the level of coordination between government agencies with respect to the distribution and approval of tests. Specifically, her legislation would direct the Government Accountability Office (GAO) to report on the COVID-19 testing actions of labs, manufacturers, state and local governments, and federal agencies—such as the FDA, the National Institutes of Health, and the U.S. Department of Health and Human Services (HHS). Additionally, the bill would require the GAO to evaluate the steps taken by labs and manufacturers to validate their tests, as well as to provide an assessment of the accuracy and sensitivity of approved COVID-19 diagnostic tests.

“A comprehensive, evidence-based testing plan is a core component of keeping our neighbors safe, successfully reopening our economy, and getting Central Virginians back to work. But over the past five months, the federal government’s testing strategy has been delayed and haphazard. The lack of a consistent and coordinated regulatory strategy has caused missed opportunities and high levels of confusion among federal agencies, private industries, and state and local governments,” said Spanberger. “My legislation is inherently forward-looking, because the public deserves to know that their government is building a plan for future COVID-19 outbreaks and is learning from testing mistakes made in the early days of this crisis. By requiring a full review of how key players evaluated, approved, and coordinated COVID-19 tests, we are shedding light on how testing policies can be improved and further expedited to keep our communities strong and safe.”

Spanberger’s bill is co-led by U.S. Representative Anthony Gonzalez (R-OH-16).

Spanberger’s legislation also calls for the GAO to assess federal actions towards tests that have not been FDA-approved. Under March 16 guidance from the FDA, a certified lab can begin marketing a diagnostic test without any kind of approval process, as long as it begins preparing a request for an Emergency Use Authorization (EUA) within 15 days. The FDA has now issued more than 90 EUAs for these diagnostic tests, and more than 240 labs have taken advantage of this relaxed regulatory approach, meaning they are now marketing their tests without any kind of FDA approval or validation—increasing the likelihood of false results.

Click here for the full bill text.

BACKGROUND

Spanberger’s legislation builds on her efforts to improve the safety and accuracy of COVID-19 tests. After a successful push from Spanberger, the FDA last week walked back a policy that allowed many companies to market unvalidated and unreliable COVID-19 antibody tests.

And since the COVID-19 pandemic began, Spanberger has called for greater accountability across the federal government’s response. Last month, she led an effort calling on the Office of the Inspector General (OIG) at HHS to open an official investigation into HHS’s stocking and deployment of personal protective equipment (PPE), ventilators, and other materials from the Stockpile ahead of COVID-19 outbreaks across the United States. Following their push, the Paycheck Protection Program and Health Care Enhancement Act­ appropriated an additional $6 million for HHS oversight activities, and the HHS OIG announced an audit of the Strategic National Stockpile’s response to the pandemic.

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