ACLA Rejects FDA As A ‘Clinical Validity’ Judge, While AdvaMedDx Seeks Tweaks To VALID Act
Clinical labs are troubled by the idea of granting US FDA vast discretion to determine if laboratory-developed tests (LDTs) are analytically and clinically valid, a key feature of the draft US VALID Act, while in vitro diagnostic kit manufacturers want some clarifications and more flexibility written into the proposal for diagnostic regulatory reforms.
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Test kit and lab firms spent tens of thousands of dollars in the first quarter of 2020 lobbying legislators to win provisions in coronavirus protection laws to ensure COVID-19 diagnostics would be a top US legislative priority.
After failing to gain traction last year, a couple of US lawmakers are hoping to garner support for a pair of bills that would require certain diagnostic tests to be regulated by the US FDA that are currently outside the scope of the agency’s oversight. The bills are intended to be a solution to concerns that certain tests do not require adequate proof of safety and effectiveness, which could lead to misdiagnoses.
In a farewell talk at the Brookings Institution, outgoing US FDA Commissioner Scott Gottlieb said a top unfinished business that he hopes gets done after his April departure is legislation to regulate laboratory developed tests. While FDA had been looking to issue guidance on LDTs, he argues there isn’t sufficient legal authority for the agency to regulate the sector.