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Pallone Demands Briefing on HHS Decision to Bypass FDA and Allow Lab Developed COVID-19 Tests to Come to Market Without Review

Aug 20, 2020
Press Release
Energy and Commerce Committee Chairman Frank Pallone, Jr. (D-NJ) released the following statement today following an announcement from the Department of Health and Human Services (HHS) allowing lab developed COVID-19 tests to come to market without Food and Drug Administration (FDA) review:
“This week’s announcement from HHS that lab developed COVID-19 tests no longer need review by FDA prior to coming to market is deeply concerning and suggests that the Trump Administration is once again interfering with FDA’s regulation of medical products.
“Given the importance of testing for our ability to control the spread of COVID-19 and the Administration’s past blunders with serological tests, I do not believe that now is the time to reduce oversight of COVID-19 tests.  The Trump Administration has continuously failed to grasp the scope of this pandemic.  Flooding the market with unregulated and potentially inaccurate tests will only further undermine our nation’s response efforts.  As FDA has repeatedly stated, inaccurate lab developed tests present a higher risk during a public health emergency and ‘should not be used for clinical diagnoses without FDA’s approval, clearance, or authorization.’
“Today, I am demanding a briefing from Secretary Azar on this change along with an explanation of why HHS is doing this now when the need for accurate tests is so critical.  We cannot afford to further undermine our nation’s response efforts as flu season approaches.”
In July, Energy and Commerce Committee leaders wrote to FDA regarding the agency’s work to determine the accuracy of COVID-19 diagnostic and serological tests. To date, the Committee has not received a response.