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- mike kraft
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HHS chief overrode FDA officials to ease testing rules
Tue, 2020-09-15 17:16 — mike kraft
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 been long 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.
That could have disastrous consequences as the country struggles to bring its coronavirus outbreak under control. False negative results could mislead some people with Covid-19 into thinking they’re free of the virus and can’t infect others. False positive results could spark unnecessary contact tracing efforts that sap already stretched resources.
Nearly a dozen current and former Trump administration officials and others with knowledge of the matter told POLITICO that the fight over lab-developed tests has driven a wedge between the agency and the health department. At some points the dispute was so intense that it boiled over into screaming matches between Azar and Hahn, four of the sources said. And FDA’s device chief, Jeff Shuren, was cut out of crucial HHS meetings leading up the policy shift.
Azar’s decision is the latest example of Trump administration appointees overruling experts at public health agencies. It comes at a particularly perilous time for the FDA, which is struggling to balance President Donald Trump’s push for a coronavirus vaccine by Election Day with public fears that the agency will rubber stamp an ineffective or even dangerous shot. ...
HHS chief of staff Brian Harrison cast the decision as driven by legal considerations, pointing to a yearslong debate over the FDA’s authority to regulate individual laboratories developing and running their own tests. ...
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