“I have never seen such complete political overrolling of the agency,” said a former HHS official. “He worries me about what’s coming.”
HHS chief Brian Harris led the decision through legal considerations and drew attention to the long-running debate over the FDA’s right to develop individual tests and regulate the conduct of their tests.
“Primarily, it was our lawyers who advised us that this [review] The requirement was illegal, “he said in a statement. “Furthermore, everyone will agree that at the beginning of the epidemic we need to accelerate the development of quality diagnostics as quickly as possible.”
Harris also denied that Azar and Heh’s disagreement led to a screaming match, calling it a “lie.”
“I was on this call and not your anonymous source,” he said. “Every interaction between the secretary and the commissioner has been very professional.”
But Han and other top FDA officials see the new policy as a force to be reckoned with by its time, in the midst of an epidemic, putting a premium on accurate Covid-19 testing, according to five people with knowledge of the matter.
Lab-developed tests or created and processed by individual labs, including commercial giants such as Quest and Labcorp, meet the increasingly comprehensive testing requirements during epidemics. A senior administration official said they could only be “overwhelmed” by the accuracy issues found in the review.
After the FDA lifted the rules for these tests at the onset of the epidemic – allowing labs to be used for emergency use – it discovered widespread errors. Of the 125 tests submitted to the FDA for authorization, Baliya eventually had “design or validation problems,” Shuren and Tim Stanzel, the FDA’s director of diagnostics, reported in The New England Journal of Medicine last week.
The agency faced such problems when it decided to hit the antibody tests market this spring without reviewing the agency. The FDA reversed the course in mid-April, recalling too many defective or inappropriate tests.
H.H.S. Officials argue that until Azare declared a public health crisis in late January, the FDA did not need to review lab-developed tests – using its discretion under the old policy.
“When the HHS learned of this regulatory barrier to testing, we asked for a legal review.” “This irregular action will better prepare us for future epidemics.”
The department also says it has not overpaid the FDA, as the FDA does not have legal authority over matters.
But many current and former officials said they now suspect that despite widespread opposition in the FDA, Azare insisted on a policy reversal despite widespread opposition in the FDA based on the agency’s willingness to take responsibility for the slow rollout of the Covid-19 tests in the early stages of the epidemic.
The current senior health official said this is his way of rewriting history and basically he says it slows down FDA testing.
After the FDA declared a public health crisis by Azar, prompting the FDA to impose a review requirement on lab-developed tests, the HHS Weeks passed, focusing on the construction and distribution of disease control and prevention testing centers, which became defective. The FDA, meanwhile, could not specify which labs to run its own tests until February 29. The week between these two major decisions is often cited as the crucial period in which the Trump administration missed the best chance of including the coronavirus.
“When he put the public health crisis in place he did not realize that he would come to the FDA and raise this obligation to get the EUA,” a senior administration official said of Azar.
H.H.S. The FDA’s decision to revoke its oversight authority has been met with little warning or compromise. The FDA regulators in charge of monitoring medical devices had no plans to approach shifts for manufacturers or the general public, nor did they make any contingency developments 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, HHSA posted a vague advertisement on its own website.
“It comes from a kind of libertarianism, ‘a health official said,’ the FDA should not interfere in the treatment of drugs’, a health official said.” But there was an accidental and clearly chaotic way about this. “
More than three weeks later, the FDA has not yet endorsed the new approach or provided any guidance on how it will be implemented. On weekly calls with agency appointees, officials did not discuss any change in policy, according to one person on the calls.
“Today we will not answer any general questions about last week’s HHS test statement,” Stanzel said in a call, according to a transcript.
Pressed on the matter during a private briefing by the House Energy and Commerce Committee on Aug 31, Hahn told lawmakers that the HHS The legal department is responsible for the decision, a source familiar with the matter said.
The FDA’s own website, meanwhile, still insists it has the power to control all types of lab-developed coronavirus tests. “Please note that LDT should not be used for clinical diagnosis without FDA approval, clearance or authorization during the emergency declaration of that disease.”
For its part, the HHSA has offered limited public health reasoning to dismiss the FDA at the crucial moment of the response, as test production increases and U.S. It comes in the fall which can lead to a resurgence of both coronavirus and seasonal flu.
Proponents of the decision argue that allowing manufacturers to bypass the potentially burdensome FDA review process could help accelerate new, more innovative tests in the market.
And within the administration, HHS officials led by General Counsel Bob Charo have been arguing for months that the FDA lacks the legal authority needed to regulate this particular team in the testing market, including labs located in large educational medical centers and small commercial laboratories. As well as a handful of large corporations.
It echoes a long-held condition by some clinical laboratories subject to agency regulation. Yet it faced stiff resistance from FDA attorneys, who maintained that the agency had long established its jurisdiction over lab-developed tests during public health crises such as the H1N1 epidemic and the Zika epidemic.
As internal controversy erupted, some White House attorneys also expressed doubts about the urgent need to move the FDA’s surveillance activities forward, said two people familiar with the situation.
However, Azar further pressed, with many officials saying that relations with top FDA executives and career employees have grown, while making some measurable progress. The fight to contain the epidemic.
Indeed, the nation faced test access issues in February and March in some parts of the country because there was no clear FDA route for emergency use of laboratory tests, said Mark McLellan, a former FDA commissioner who spoke to HHS about the testing strategy. Advised.
But “since then, I think they’ve got it right, or at least made real progress,” he said.
A Republican close to the administration added that there is no problem with the LDT or clearly any test being obtained quickly by the FDA right now. On the other hand, going to war with his own agency in the middle of the crisis, “with the obscure things out there so far.”
David Lim contributed to this report.
