Two months before Health and Human Services Secretary Alex Azar overruled FDA officials to revoke the agency’s oversight of lab-developed tests this August, the health department’s top lawyer began building a legal case that would lead to its controversial decision to remove that authority, according to a memo obtained by POLITICO.
The memo offers new insight into how HHS officials revoked the FDA’s ability to regulate the safety and quality of tests developed by labs for their own use, despite fierce protests from FDA Commissioner Stephen Hahn and other FDA officials, some of whom believed it could allow low-quality tests to flood the market and undermine the country’s ability to track the coronavirus.
The decision rattled regulators at FDA and sparked probes from Democratic lawmakers, who cited it as another example of politics guiding the Trump administration’s coronavirus response. Ahead of a hearing with Azar on Friday, the House Oversight Committee released a report condemning “political interference” at the health department and criticizing HHS for “overrid[ing] FDA and increas[ing] the risk of inaccurate coronavirus tests flooding the market.”
Lab-developed tests are created and used within a single laboratory for a wide range of diseases. There’s long been questions about whether FDA had the authority to regulate these tests as medical devices, which include certain offerings from lab giants like Quest and LabCorp. But the timing of HHS’ decision raised eyebrows among public health officials who worry that looser standards will allow a surge of unreliable Covid-19 tests, as was the case early in the outbreak.
FDA officials have said they were largely blindsided by the decision to roll back FDA authority, which was announced in a brief post to the HHS website. The move was a culmination of a months-long battle over the test policy that began in the early days of the pandemic.
The newly revealed memo from HHS general counsel Robert Charow, dated June 22, indicates Hahn and other senior HHS officials were notified months earlier that the department was intensifying its review of FDA’s testing oversight.
“We have been asked by departmental leadership to review the legal bases — both substantive and procedural — for FDA’s regulation of laboratory developed tests,” Charow wrote in that memo.
Asked about the reasons behind the memo, an HHS spokesperson referred to a “frequently asked questions” document posted by the department. An individual familiar with the legal review of FDA’s policy said that it was requested by Azar’s top aide, chief of staff Brian Harrison.
FDA declined to comment.
Ultimately, Charrow concluded, the legal authority that FDA relied on for nearly 30 years to regulate lab-developed tests had “several weaknesses” — such as a failure to pursue notice-and-comment rulemaking — that would render the agency’s policy vulnerable to a lawsuit from labs.
Hospitals and doctors blamed FDA’s restrictions on using lab-developed tests for delays in rolling out Covid-19 testing early in the pandemic. Some FDA officials said Azar failed to anticipate how his declaration of a public health emergency for the coronavirus in late January would prompt additional FDA reviews of lab-developed tests.
In response to criticism of its stringent testing oversight, FDA significantly loosened its standards on Feb. 29 to allow labs to market the lab-developed tests once they validated the test and submitted an emergency use application to the agency within 15 business days.
FDA officials have long argued that their agency should have regulatory authority over lab-developed tests. Jeff Shuren, the agency’s chief medical device regulator, and diagnostics director Tim Stenzel wrote in the New England Journal of Medicine last month that the decision to speed lab-developed tests to market with little oversight proved problematic.
Tests were available more quickly, but less-rigorous standards for emergency use authorization and slower FDA review allowed use of tests “that ultimately proved to have performance problems or to be poorly validated,” the FDA officials wrote. “In analyzing 125 EUA requests from laboratories, we identified 82 with design or validation problems, and several have been denied authorization.”