Subcommittee Chair Krishnamoorthi Joins CBS 60 Minutes to Discuss His Coronavirus Antibody Testing Investigation

Jun 29, 2020
Press Release

Washington, D.C. (June 29, 2020)—Below are highlights from an interview that Subcommittee on Economic and Consumer Policy Chairman Raja Krishnamoorthi had with CBS 60 Minutes to discuss his investigation into the Food and Drug Administration (FDA) regulation and review of coronavirus tests and the policies regarding coronavirus blood tests issued by the Centers for Disease Control and Prevention (CDC). 

 

“The FDA was not policing this market.  They adopted what’s called a ‘self-validation and voluntary compliance system.’”

 

“Basically they were asking companies to validate that their test worked.  And guess what, every company said they did.”

 

“We’ve never seen anything like this, in terms of a policy, which is basically an ‘anything goes’ ‘wild west’ type of approach to regulating a health care market.  We just haven’t seen that.”

 

“When you open the floodgates to virtually any product, being sold by anybody … people who are preying on unsuspected consumers enter the fray.”

 

Investigation Timeline:

 

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

 

On April 24, 2020, Subcommittee Chair Krishnamoorthi released a staff memo detailing preliminary findings of the Subcommittee’s investigation.  FDA Commissioner Hahn did not refute the staff memo’s findings 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 into the market.

 

On April 28, 2020, Chair Krishnamoorthi sent letters to four companies—UCP Biosciences, Inc.BioMedomics, Inc.Epitope Diagnostics, Inc., and Premier Biotech, Inc.—that manufacture or distribute tests that University of California researchers found did not deliver consistently reliable results, seeking information about their interactions with FDA and data supporting claims about the accuracy of their tests.

 

On April 29, 2020, Subcommittee Chair Krishnamoorthi sent another letter calling on FDA to change its hands-off policy and pressing for compliance in the Subcommittee’s investigation.

 

On May 4, 2020, 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.

 

On June 9, 2020, Chair Krishnamoorthi convened a video briefing to examine the role that serological antibody tests play in the response to the coronavirus pandemic, recommendations and limitations for their use, and federal policy.

 

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116th Congress