ARTICLE SUMMARY:
Members of Congress press HHS to reverse Trump administration's laboratory developed test policy.
Leading House Democrats are calling on FDA to reassert its premarket review authority for laboratory developed tests (LDTs) for COVID-19. House Energy and Commerce Committee Chair Frank Pallone (D-NJ) and Reps. Anna Eshoo (D-CA) and Diana DeGette (D-CO), chairs of the Health and Oversight and Investigations Committees, respectively, wrote to HHS Secretary Xavier Becerra May 11, calling on him to reverse the Trump-era department’s recission notice last August, ruling that FDA couldn’t require review of LDTs without pursuing formal rulemaking.
While FDA historically exercises enforcement discretion for LDTs—which are test services developed and conducted by the same lab—the agency has typically required labs to submit EUAs during public health emergencies. FDA stuck with that policy at the start of the pandemic last year, but labs complained delays at FDA were hindering the US testing response to COVID-19. In response, FDA loosened its rules for both LDTs and IVD COVID-19 test kits. But HHS’ August decision to restrict FDA from requiring LDT EUAs reportedly took FDA by surprise and set off a tit-for-tat with the agency. FDA said it wouldn’t accept voluntary LDT submissions, cutting a route to liability protections for labs, and HHS tried to offer alternative validation pathways through the National Cancer Institute and even a private contractor rather than FDA.
“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 Becerra. “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.” The letter comes as the Energy and Commerce Committee may be preparing to push forward an effort that would more concretely address longstanding ambiguities in the oversight of LDTs for both non-emergency and emergency tests. The VALID Act, formally introduced in Congress in March 2020, would combine LDTs and IVD kits into a new legal category (In Vitro Clinical Tests, IVCTs) that would explicitly be regulated by FDA. Stakeholders anticipate renewed committee attention to the bill during summer.
Excerpted from “Pathways Picks May 12: Diagnostic Picks, Asia Updates, and More to Watch,” Market Pathways, May 12, 2021.
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