“Unfortunately, despite objections from career scientists at FDA and other public health experts, the Trump Administration policy revoking FDA’s authority remains in place,” the Committee leaders wrote to Secretary Becerra. “Access to accurate diagnostic tests is a vital piece of our ongoing effort to stop the spread of COVID-19 and eventually ending the pandemic. We therefore request that you immediately reverse the Trump Administration’s shortsighted policy and restore FDA’s premarket review authority and oversight over COVID-19 LDTs.”
In August, the Trump Administration upended longstanding LDT policy when HHS hastily posted a one-paragraph announcement stating that FDA would no longer require premarket review of COVID-19 LDTs. Although HHS said in its announcement that LDT developers could continue to voluntarily seek Emergency Use Authorizations (EUA) for their tests, FDA then announced in October that it would decline to review EUA requests for LDTs.
In response to concerns that new LDTs would no longer be eligible for liability protections under the Public Readiness and Emergency Preparedness (PREP) Act, the Trump Administration then attempted to shoehorn a fix to the problem of its own creation by instructing the National Cancer Institute (NCI) to review LDTs in FDA’s stead. In the final days of the Trump Administration, HHS also entered into an uncompetitive, sole source contract to farm out LDT review to a private consulting firm.
“Only FDA has the legal responsibility, as well as the experience and expertise, to evaluate the accuracy and reliability of diagnostic tests. In the midst of a viral pandemic, this responsibility should not be handed off to an obscure federal contractor or a different enterprise within the federal government,” the Committee leaders concluded. “As our nation continues to confront the COVID-19 pandemic with a hope of soon returning to normal patterns of life, access to accurate and reliable tests will remain critical. We ask that you take steps to ensure the quality of these tests by reversing the Trump Administration’s misguided policy on LDTs and restoring FDA’s premarket review authority.”
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