[Photo by Fusion Medical Animation on Unsplash]
Such a requirement in the future will need notice-and-comment rulemaking versus guidance documents, compliance manuals, website statements or other informal issuances, HHS said in the decision posted Aug. 19.
The decision stated: “The Trump Administration is committed to combating COVID-19, to ensuring that the American people are protected against future pandemics, and to keeping duplicative regulations and unnecessary policies from interfering with those efforts.”
The move appears to have surprised FDA insiders and comes after disagreements between HHS Secretary Alex Azar and FDA Commissioner Stephen Hahn, according to The Washington Post, which cited people familiar with the situation who spoke on the condition of anonymity because they did not have clearance to talk about it. Hahn had argued that FDA has the authority to regulate laboratory-developed tests during a public health emergency such as a pandemic.
President Donald Trump has recently been ramping up criticism of FDA. For example, Politico reports that he suggested earlier this month that government scientists don’t want to approve treatments such as convalescent plasma until after Election Day.
AdvaMed CEO Scott Whitaker in a statement called on the administration to support the creation of a single regulatory framework for both in vitro diagnostics (IVDs) developed and made by the trade group’s members, and laboratory-developed tests (LDTs).
“We encourage 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,” Whitaker said. “Strategic testing of symptomatic patients and broad screening of asymptomatic individuals are critical to managing the pandemic, and the tests that guide our response should have the confidence of both patients and the public.
“AdvaMed and our partners in the laboratory, health system and patient communities have been working collaboratively to advance legislation that would establish a modernized and right-sized, diagnostics-specific regulatory framework that would embrace innovation so that high-quality diagnostic testing is made rapidly available to patients.”
Patient safety activist Madris Tomes told MDO and MassDevice via email that while she understands the drive to reduce barriers to entry during the pandemic, removing the approval process also means removing the opportunity for the FDA to flag tests that may be performing under par.
“It also removes the post-market oversight that is required for devices cleared or approved by the FDA. That oversight is critical in these times to ensure that providers are using the best tests available. Having all tests cleared and monitored by a single entity (i.e. the FDA) could improve communication and better ensure the efficacy of COVID testing,” said Tomes, CEO of Device Events and a former FDA manager.
