Health and Human Services Secretary Alex Azar led an escalating pressure campaign against his own Food and Drug Administration this spring and summer, urging the agency to abandon its responsibility for ensuring the safety and accuracy of a range of coronavirus tests as the pandemic raged.
Then in late August, Azar took matters into his own hands. Overriding objections from FDA chief Stephen Hahn, Azar revoked the agency’s ability to check the quality of tests developed by individual labs for their own use, according to seven current and former administration officials with knowledge of the decision.
The unilateral policy change — which applies to “lab-developed” tests for a wide range of diseases, including Covid-19 — had long been sought by commercial, university and public health labs in the name of greater flexibility. But Hahn viewed the move as inappropriate and ill-timed because it removed safeguards designed to prevent inaccurate tests from flooding the market during a public health crisis.