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Sunday, October 2nd, 2022

House E&C committee leaders urge HHS Secretary to restore FDA authority over COVID-19 lab-developed tests

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Leaders of the House Energy and Commerce Committee and subcommittees wrote to Health and Human Services (HHS) Secretary Xavier Becerra this week urging a reversal of a Trump administration policy that stripped Food and Drug Administration (FDA) authority over COVID-19 lab-developed tests (LDTs).

E&C Chairman Frank Pallone, Jr. (D-NJ) was joined by Health Subcommittee Chairwoman Anna Eshoo (D-CA) and Oversight and Investigations Chair Diana DeGette (D-CO) on the letter, which called for immediate restoration of FDA premarket review requirements for LDTs. That requirement, once longstanding, was obliterated in August 2020 via a one-paragraph announcement from the HHS. While HHS initially said LDT developers could continue voluntarily seeking Emergency Use Authorizations (EUA) instead, the FDA later announced it would decline to review those as well.

“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. “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.”

Since FDA lost power over LDTs, the situation has become more complicated. The Trump administration became quickly aware of and concerned that by removing the review process, LDTs would no longer be eligible for liability protections. As a result, the administration set the National Cancer Institute (NCI) to oversee LDT reviews, then changed course again, issuing a sole source contract under which a private consulting firm would handle LDT reviews.

At the time, FDA officials warned the decision could lead to inaccurate tests flooding the market. Even before the policy changes went into effect, the FDA had found numerous tests being poorly designed or validated. Until the change, the FDA had generally worked with labs to correct any issues and keep tests flowing.

“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.”