Top Dems Mount Pressure On Becerra To Reverse COVID-19 LDT Policy Stopping FDA Oversight
Democratic lawmakers are adding to the growing number of voices demanding the US FDA be able to regulate COVID-19 laboratory developed tests. They argue reliable and accurate tests are needed to restart the economy.
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The non-partisan policy think tank wants the administration to permanently rescind a number of recent Trump HHS policies, including one that stops the FDA from regulating laboratory developed tests.
The tug of war between the US HHS and the FDA over laboratory developed tests took a surprising turn on 7 October when the agency declared that it will no longer issue emergency use authorizations for LDTs. That means unapproved COVID-19 tests that come to market without an EUA won’t be covered under the PREP Act, which protects makers of pandemic-fighting products from lawsuits.
US regulators say Verily’s Study Watch – meant to be used in Parkinson’s trials – doesn’t collect data needed to assess whether a patient is truly benefitting from a drug.