Timothy Stenzel, the federal regulator who led the Food and Drug Administration’s diagnostics division during the chaotic time of Covid-19 pandemic, has left the agency. The FDA confirmed Thursday that Stenzel, who led the FDA’s office of in vitro diagnostics, retired at the end of 2023.
During the early days of the pandemic, Stenzel was in the middle of a turf battle between the Centers for Disease Control and Prevention and the FDA over the regulation of Covid tests. At one point, the CDC made Stenzel wait at its facility overnight after he arrived for a meeting on Covid test development, Politico reported at the time.
It was a hectic time. Testmakers rapidly introduced new Covid-19 screening products with little data, as it was a brand new virus. The pandemic especially laid bare FDA’s inability to control lab-developed tests (LDTs). Many of the Covid-19 PCR tests fell in this category. Early on, using powers granted by the public health emergency, the FDA required labs to apply for emergency use authorization. But a STAT investigation found that the Department of Health and Human Services told the FDA to stop this measure, despite knowing that many of the tests may have been inaccurate.
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