Subcommittee Investigation Leads to FDA Increasing Oversight and Accuracy on Serology Testing

May 4, 2020
Press Release

Washington, D.C. (May 4, 2020)—Today, Rep. Raja Krishnamoorthi, the Chairman of the Subcommittee on Economic and Consumer Policy, issued the following statement after the Food and Drug Administration (FDA) revised its policy on serological antibody testing to address wide gaps in the Trump Administration’s handling of serology tests identified in the Subcommittee’s investigation:

 

“In response to my Subcommittee’s investigation exposing failure and fraud in the serology test market, FDA admitted its mistakes and made critically needed changes to its policy to require FDA review of all antibody tests on the market.  As our investigation revealed, FDA’s prior laissez-faire policy let more than 150 tests go to market without any review, flooding the market with inaccurate and falsely marketed tests.  Now, FDA must expeditiously conduct its review and clear the market of tests that don’t work or aren’t submitted for review, so that consumers can take confidence that testing services they receive are reliable and trustworthy.”

 

Following the Subcommittee’s month-long investigation into serology testing, FDA answered the Subcommittee’s call to review every serological test on the market, and to set standards by which to measure the accuracy of those tests.

 

On April 9, 2020, Subcommittee Chairman Krishnamoorthi sent a letter to FDA Commissioner Stephen Hahn, raising issues with FDA’s serological testing policy.

 

On April 24, 2020, FDA Commissioner Hahn addressed the Subcommittee’s just-released staff memo during the White House Coronavirus Task Force briefing.  Also, researchers confirmed the Subcommittee’s concern that FDA’s lax policies are permitting a flood of fraudulent tests onto the market.

 

On April 29, 2020, Krishnamoorthi sent another letter to the Food and Drug Administration (FDA) pressing for compliance in the Subcommittee’s investigation into the agency’s policies. 

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Issues: 
116th Congress