UPDATE: August 21, 2020: Frank Pallone, D-N.J., chairman of the House Energy and Commerce Committee, on Thursday demanded a briefing from HHS Secretary Alex Azar on the policy change. Pallone in a statement called the decision "deeply concerning" as the Trump administration appears to again be interfering with FDA’s regulation of medical products. "Flooding the market with unregulated and potentially inaccurate tests will only further undermine our nation’s response efforts," Pallone said.
AdvaMed CEO Scott Whitaker in a statement encouraged the Administration to "ensure all diagnostic test developers, of both IVDs and LDTs, are subject to the same standard of test validation during the pandemic and beyond to protect patients and public health."
- The FDA will no longer require CLIA labs wanting to create COVID-19 diagnostics, and other laboratory developed tests, to go through the agency's premarket review process, the Department of Health and Human Services said in a notice issued late Wednesday.
- HHS said the decision was made as part of its ongoing department-wide review of "regulatory flexibilities" put into place since January's public health emergency declaration in response to the coronavirus pandemic. While labs can voluntarily seek approval, clearance, or emergency use authorization for an LDT, they are not required to do so, according to the notice.
- Rachel Sachs, associate professor of law at Washington University School of Law, called the paragraph-long announcement "puzzling," and said the lack of information from the agency is not typical of a change of this nature. Sachs also noted that as of Thursday morning the FDA's website still states that EUAs are required for LDTs during the pandemic.
The fact that the policy change was issued by HHS, and not FDA, has drawn the attention of industry observers. While the Trump administration has been relatively consistent in a drive to deregulate, the timing took some by surprise.
"It's particularly concerning to see them do this in the middle of a pandemic," Sachs said.
The American Clinical Laboratory Association is reviewing the HHS announcement, the group's president Julie Khani president said, noting LDTs have played a crucial role in responding to the pandemic.
"Any regulatory framework for laboratory developed tests must provide for continued innovation while ensuring public confidence in the accuracy and reliability of test results," a statement said.
HHS said the administration is dedicated to "keeping duplicative regulations and unnecessary policies from interfering with" efforts to stymie COVID-19 and protect against future pandemics.
Politico reported late Wednesday that the policy change has been a "major point of tension for weeks between HHS and FDA. And FDA spokesperson Emma Spaulding declined to comment and deferred all questions to HHS.
Sachs has concerns that with the new policy change FDA might now go down the same path with LDTs as it did earlier in the pandemic with coronavirus antibody tests, for which the agency did not initially require review.
In mid-March, FDA began allowing developers of serologic assays to self-validate products and bring them to market. However, the agency later acknowledged that its hands-off approach to the regulation of antibody tests caused unintended consequences and FDA reversed track.
"Many of the tests that had entered the market were not of very good quality," Sachs said.
She contends there's real potential for the country to experience the same kind of problem with LDTs now that there is no premarket review required.
Sachs noted that to date 35 EUAs have been granted by FDA to LDTs, a relatively small number compared to the overall amount of COVID-19 tests that have gotten the nod from the agency. However, she makes the case that the number of diagnostics from CLIA labs could grow significantly now that they are no longer subject to the same regulatory requirements as non-LDT coronavirus tests.
"Companies, if they can, will design their testing strategies and business models to avoid burdensome federal regulation. As a result, there's no reason to be confident that LDTs will continue to be a small fraction of the tests that are available," Sachs said.
The impact goes beyond COVID-19 as the new policy will apply for all LDTs.