“I’ve never seen such a complete political crackdown on the agency,” said one former HHS official. “It makes me worry about what’s next.”
HHS Chief of Staff Brian Harrison described the decision as a legal matter, pointing to years of debate over the FDA’s power to regulate individual laboratories that develop and conduct their own tests.
“First of all, it was our lawyers who advised us that this [review] the demand was illegal, ”the statement said. “In addition, everyone will agree that at the onset of a pandemic, we need to maximize the development of quality diagnostics as quickly as possible.”
Harrison also denied that Azar and Khan’s disagreement led to screaming matches, calling it a “lie.”
“I was on this call, but your anonymous source was not,” he said. “All interactions between the secretary and commissioner were highly professional.”
But Khan and other senior FDA officials see the new policy as a stunning attempt at grabbing power that is even more unwelcome due to its timing, in the midst of a pandemic that five people familiar with the situation said has prioritized accurate testing for Covid-19. cause.
Tests developed in laboratories or created and processed by individual laboratories, including commercial giants such as Quest and LabCorp, are increasingly meeting the broad testing needs during a pandemic. But they can be “fraught” with accuracy problems that can only be detected by verification, said one senior administration official.
After the FDA loosened rules for these tests in the early stages of the pandemic, allowing laboratories to delay getting an emergency use authorization, it found widespread flaws. Of the 125 tests ultimately submitted to the FDA for authorization, 82 had “design or validation issues,” Shuren and FDA director of diagnostics Tim Stenzel said last week. New England Journal of Medicine…
The agency faced similar problems when it decided this spring to market antibody tests without agency verification. The FDA changed course in mid-April, citing multiple flawed or inaccurate tests.
HHS officials say that until Azar declared a public health emergency in late January, the FDA did not require laboratory test reviews – at its discretion, in line with old policy.
“When HHS became aware of this regulatory impediment to testing, we asked for a legal due diligence,” Harrison said. “This deregulation will better prepare us for future pandemics.”
The department also claims it has not overturned the FDA “because the FDA does not have jurisdiction over matters of law,” he added.
But several current and former officials said they now suspect Azar pushed for a policy change despite widespread opposition within the FDA, in part out of a desire to hold the agency responsible for the slow rollout of Covid-19 tests in the early stages of the pandemic.
“This is their way of rewriting history and essentially saying this is FDA slowdown testing,” said the current senior health official.
After Hazard declared a public health emergency, prompting the FDA to impose a requirement for laboratory tests to be screened, HHS spent weeks focusing solely on creating and distributing the Centers for Disease Control and Prevention tests that proved to be flawed. The FDA, meanwhile, hasn’t allowed labs to run their own tests until February 29. The weeks between these two important decisions are often referred to as the critical period during which the Trump administration missed its best chance to contain the coronavirus.
“When he declared a public health emergency, he didn’t realize that it would lead the FDA to take responsibility for getting approval to participate in the EUA program,” a former senior administration official said of Azar.
HHS’s August 20 decision to revoke the FDA’s supervisory authority came with no warning or compromise. The FDA regulators responsible for monitoring medical devices did not have a plan to inform manufacturers or the general public about the transition, nor did they develop any contingencies on how to proceed.
According to a senior HHS official, senior FDA officials refused to publicly announce the change themselves, in an unusual move. Instead, HHS posted a short announcement on its website.
“It comes from a kind of libertarian point of view: ‘The FDA should not interfere with the practice of medicine,’ said one health official. “But it was such a harsh and overtly chaotic way of doing it.”
More than three weeks later, the FDA has still not approved the new approach or made any recommendations for its implementation. During weekly phone calls with agency stakeholders, officials did not discuss any policy changes, according to one participant in the call.
“Today we won’t be answering any general questions about the HHS tests last week,” Stenzel said during one of the calls, according to the transcript.
At a private briefing by the House Energy and Commerce Committee on the matter on August 31, a source familiar with his comments said Khan told lawmakers that the legal arm of HHS is responsible for the decision.
Meanwhile, the FDA’s own website still insists that it has the authority to regulate all kinds of laboratory tests for the coronavirus. “Please note that LDT should not be used for clinical diagnoses without FDA approval, authorization, or clearance at the time of an emergency announcement for this disease,” the website says.
For its part, HHS has offered limited public health rationale for the FDA’s suspension at a crucial moment in the response as test production rises and the US approaches the fall season, which could spark a resurgence of both coronavirus and seasonal flu.
Proponents of the decision argue that a weaker approach could help speed up the release of new, more innovative tests to market, allowing manufacturers to bypass the potentially cumbersome FDA verification process.
And within the administration, senior HHS officials, led by General Counsel Bob Charrow, argued for months that the FDA lacked the legal authority needed to regulate this particular segment of the testing market, which includes laboratories located in larger academic medical centers and small commercial laboratories as well as a handful of large corporations.
This echoes the position taken by some clinical laboratories subject to agency regulation for a long time. However, it faced fierce opposition from FDA attorneys, who argued that the agency had long since established jurisdiction over laboratory tests during previous public health emergencies such as the H1N1 pandemic and the Zika virus outbreak.
As the internal dispute escalates, some White House lawyers are also skeptical of the immediate need to curtail FDA oversight, two people familiar with the situation said.
However, Hazard insisted, a decision that several officials said has soured relationships with senior FDA officials and workforce, while making little measurable progress infight to contain the pandemic.
Indeed, the country faced major challenges in accessing testing in February and March in part because the FDA did not have a clear path for emergency use of laboratory tests, said former FDA Commissioner Mark McClellan, who advised HHS on testing strategy.
But “since then, I think they got it right, or at least made real progress,” he said.
“There is no problem now with LDT or, frankly, with any tests that go through the FDA quickly,” added a Republican close to the administration. On the other hand, going to war with your own agency in the midst of a crisis is “on a par with the dumbest things.”
