Lawmakers to Becerra: Restore FDA’s authority to review COVID-19 tests prior to market

WASHINGTON, D.C. – U.S. Reps. Diana DeGette (D-CO), Frank Pallone, Jr. (D-NJ) and Anna G. Eshoo (D-CA) sent a letter today to Health and Human Services Secretary Xavier Becerra urging him to immediately reverse the Trump Administration's policy that revoked the Food and Drug Administration's power to review the accuracy of some COVID-19 tests before they are used to screen people for the virus.

"Despite objections from career scientists at FDA and other public health experts, the Trump Administration policy revoking FDA's authority remains in place," the lawmakers wrote. "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 [Laboratory Developed Tests]."

In August, the Trump Administration ended a longstanding federal policy that required tests developed during a public health emergency – such as those used to screen for COVID-19 – be approved by FDA before they are made available to the public. The policy change was made in a one-paragraph announcement hastily posted on the Department of Health and Human Services' website.

Although HHS said at the time that LDT developers could continue to voluntarily seek premarket approval for their COVID-19 tests, FDA later announced in October that it would no longer review such requests.

In response to concerns that newly developed LDTs would not be eligible for liability protections under the Public Readiness and Emergency Preparedness, or PREP, Act without premarket approval, the Trump Administration later announced that the National Cancer Institute would review any new LDT requests instead of FDA.

HHS then, in the final days of the Trump administration, entered into an uncompetitive, sole-source contract to farm out any future LDT reviews 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," the lawmakers wrote to the new head of HHS. "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. 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."

A copy of the lawmakers' letter to Becerra is available here.