“I’ve never seen such a complete political overruling of the agency,” said one former HHS official. “It makes me worried about what’s to come.”
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.
“Primarily, it was our lawyers advising us that this [review] requirement was illegal,” he said in a statement. “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.”
“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.
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 only spotted in review, said one senior administration official.
After the FDA loosened the rules for these tests early in the pandemic — allowing labs to delay seeking emergency-use authorization — it discovered widespread flaws. Eighty-two of 125 tests eventually submitted to FDA for authorization had “design or validation problems,” Shuren and FDA’s diagnostics director, Tim Stenzel, reported last week in The New England Journal of Medicine.
The agency experienced similar problems when it decided this spring to let antibody tests hit the market without agency review. FDA reversed course in mid-April, recalling scores of faulty or inaccurate tests.
Officials at HHS argue that until Azar declared a public health emergency in late January, the FDA did not require reviews of lab-developed tests — exercising its discretion under the old policy.
“When HHS learned of the creation of this regulatory hurdle to testing we asked for legal review,” Harrison said. “This deregulatory action will better prepare us for future pandemics.”
The department also maintains that it did not overrule FDA, “because FDA has no jurisdiction of matters of law,” he added.
But several current and former officials said they now suspect Azar insisted on the policy reversal despite widespread opposition within the FDA based in part on a desire to pin responsibility on the agency for the slow rollout of Covid-19 tests early in the pandemic.
“This is their way of rewriting history and basically saying it’s the FDA slowing down testing,” said a current senior health official.
After Azar declared the public health emergency, prompting the FDA to impose the review requirement for lab-developed tests, HHS spent weeks focused solely on the creation and distribution of a Centers for Disease Control and Prevention test that turned out to be flawed. The FDA in the meantime did not clear any labs to run their own tests until Feb. 29. The weeks in between those two major decisions are often cited as the critical period during which the Trump administration squandered its best chance to contain the coronavirus.
“When he put the public health emergency in place, he didn’t realize it was going to trigger this responsibility at FDA to go in and get an EUA,” a former senior administration official said of Azar.
HHS’ decision on Aug. 20 to revoke the FDA’s oversight authority came with little warning or compromise. FDA regulators in charge of monitoring medical devices had no plan for communicating the shift to manufacturers or the broader public, nor had they developed any contingencies for what to do next.
And in an extraordinary move, top FDA officials refused to publicly announce the change themselves, a senior HHS official said. Instead, HHS posted the terse announcement to its own website.
“It comes from a sort of libertarian, ‘FDA shouldn’t interfere with the practice of medicine’ viewpoint,” said one health official. “But this was such an abrupt and frankly chaotic way to go about it.”
More than three weeks later, the FDA has still yet to endorse the new approach or offer any guidance for how it will be implemented. On weekly calls with agency stakeholders, officials have not discussed any change in policy, according to an individual on the calls.
“Today we will not be answering any general questions about the HHS test statement of last week,” Stenzel said on one of the calls, according to a transcript.
Pressed on the matter during a private briefing of the House Energy and Commerce Committee on Aug. 31, Hahn told lawmakers that HHS’ legal division was responsible for the decision, a source familiar with his comments said.
The FDA’s own website, meanwhile, still insists that it has the power to regulate all manner of lab-developed coronavirus tests. “Please note that LDTs should not be used for clinical diagnoses without FDA’s approval, clearance or authorization during an emergency declaration for that disease,” the site reads.
For its part, HHS has offered limited public health rationale for sidelining the FDA at a pivotal moment in the response, as test production ramps up and the U.S. heads into a fall season that could bring a resurgence of both the coronavirus and the seasonal flu.
Supporters of the decision contend that the more lax approach could help speed newer, more innovative tests onto the market by allowing manufacturers to bypass the potentially cumbersome FDA review process.
And inside the administration, top HHS officials led by General Counsel Bob Charrow argued for months that the FDA lacked the legal authority required to regulate this particular slice of the testing market, which includes labs located in larger academic medical centers and smaller commercial laboratories, as well as a handful of large corporations.
That echoes a position long held by some clinical laboratories subject to the agency’s regulation. Yet it encountered fierce resistance from FDA attorneys who maintained that the agency had long established its jurisdiction over lab-developed tests during prior public health emergencies like the H1N1 pandemic and Zika outbreak.
As the internal dispute mushroomed, some White House lawyers also expressed skepticism of the immediate need to pare back the FDA’s oversight activities, two people with knowledge of the situation said.
Azar nevertheless pressed ahead, a decision several officials said had soured relations with top FDA officials and career staff while accomplishing little measurable progress in the fight to contain the pandemic.
Indeed, the nation faced major testing access issues in February and March in part because there was no clear FDA pathway for emergency use of lab tests, said former FDA Commissioner Mark McClellan, who has advised HHS on testing strategy.
But “since then, I think they have kind of got it right, or at least made real progress,” he said.
“There’s no issue with LDTs or frankly any test getting quickly through the FDA right now,” a Republican close to the administration added. Going to war with its own agency in the middle of a crisis, on the other hand, ranks “right up there with the dumbest things ever.”
David Lim contributed to this report.