POLITICO Report: Conflict Between HHS Secretary and FDA Officials Over FDA Lab Safety Role
On Sep. 15, reporters Adam Cancryn and Sarah Owermohle of POLITICO published a report in that publication online that examined the possible politicization of the Department of Health and Human Services (HHS) with regard to issues around COVID-19 testing—with very major potential implications for coronavirus testing hospitals and other patient care organizations and across the U.S. healthcare system. The report included statements from HHS officials making statements of their own regarding the current situation inside the department, which encompasses the Food and Drug Administration (FDA), the federal agency charged with the authority to certify the quality of laboratory tests.
Cancryn and Owermohle wrote on Tuesday afternoon that “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,” they wrote.
The reporters went on to say that “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. That could have disastrous consequences as the country struggles to bring its coronavirus outbreak under control,” they wrote. “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.”
And, Cancryn and Owermohle wrote, “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.” “I’ve never seen such a complete political overruling of the agency,” one former HHS official told the reporters. “It makes me worried about what’s to come.”
But Cancryn and Owermohle were also able to get an on-the-record response from an HHS spokesperson. “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,” they wrote, quoting him as saying in a statement that, “Primarily, it was our lawyers advising us that this [review] requirement was illegal. Additionally, everyone would agree that at the beginning of a pandemic we need to maximize the development of quality diagnostics as fast as possible.” Harrison also denied that Azar and Hahn’s disagreement led to screaming matches, calling it “a lie.” Indeed, “I was on this call and your anonymous source was not,” he said. “Every interaction between the secretary and commissioner has been highly professional.”
“But Hahn and other top FDA officials see the new policy as a bewildering power grab made even more objectionable by its timing, coming in the midst of a pandemic that has put a premium on accurate Covid-19 testing, according to five people with knowledge of the matter,” Cancryn and Owermohle wrote. “Lab-developed tests, or those made and processed by individual labs, including commercial giants like Quest and LabCorp, have increasingly filled broad testing needs during the pandemic. But they can be ‘fraught’ with accuracy problems spotted only in review, said one senior administration official.”
