Subcommittee Chair Krishnamoorthi to Hold Briefing Examining State of Coronavirus Antibody Testing

Jun 8, 2020
Press Release

Washington D.C. (June 8, 2020)—On Tuesday, June 9, 2020, Rep. Raja Krishnamoorthi, the Chairman of the Subcommittee on Economic and Consumer and Policy, will hold 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.

On March 16, 2020, the Food and Drug Administration (FDA) issued a policy for serology tests for coronavirus.  Under so-called “Pathway D” of the policy, a manufacturer could distribute serological test kits by self-validating the test, notifying FDA of the self-validation, and providing a disclaimer with test results that FDA had not reviewed the test and the test should not be used as the sole basis for diagnosis. 

On April 9, 2020, the Subcommittee launched an investigation into serology testing with a letter to FDA and the Centers for Disease Control and Prevention (CDC), citing concerns about inaccurate serology tests on the market, many of which were manufactured in China, that “could be quite dangerous.” 

On April 24, 2020, the Subcommittee issued a staff report detailing that FDA was not reviewing antibody test kits that went on the market through Pathway D, and had failed even to ask for information that would have allowed FDA to conduct a cursory review of the tests’ effectiveness.  FDA Commissioner Stephen Hahn did not dispute the Subcommittee’s findings and characterized serology tests as “self-validated during a White House Coronavirus Task Force briefing.

On April 28, the Subcommittee sent FDA a letter calling on it to change its policy.  Days later, on May 4, FDA revised its policy on antibody tests, requiring all manufacturers of serology test kits to apply for Emergency Use Authorization (EUA) within 10 days.  The immediate result of the policy change was that FDA placed 31 tests on a public do-not-distribute list.  However, over 190 tests that have not received EUAs are listed on FDA’s website as able to be marketed under this policy.

While antibody tests have important uses for the public health response and provide valuable information to epidemiologists and public health officials, CDC’s interim guidelines state that serology tests “should not be used to make decisions about returning persons to the workplace,” and they “should not be used to make decisions about grouping persons residing in or being admitted to congregate settings, such as schools, dormitories, or correctional facilities. 
 

WHAT:  

Subcommittee on Economic and Consumer and Policy Briefing on “COVID-19 Antibody Testing:  Uses, Abuses, Limitations, and the Federal Response”

WHEN:

11:00 AM ET on Tuesday, June 9, 2020

WHO:    

 

Dr. Jesse Goodman, MD, MPH
Director, Center on Medical Product Access, Safety and Stewardship (COMPASS)
Georgetown University
Former-Chief Scientist, Food and Drug Administration

Dr. Jennifer Rakeman, PhD
Assistant Commissioner
New York City Department of Health and Mental Hygiene

Dr. Gigi Gronvall, PhD
Senior Scholar & Associate Professor
Johns Hopkins Bloomberg School of Public Health, Center for Health Security

Dr. Jesse Ehrenfeld, MD, MPH
Chair, Board of Trustees
American Medical Association

WATCH:

A livestream will be available on YouTube and the Committee on Oversight and Reform website.

 

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Issues: 
116th Congress