Senators Push OMB For Lab-Developed Test Guidance, Academic Labs Resist
This article was originally published in The Gray Sheet
Several Democratic Senators want the Office of Management and Budget to release the FDA draft guidance on lab-developed tests that has been stuck at OMB for years. Academic clinical labs send their own letter to the budget office, pleading that the guidance not be released.
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Both Democratic and Republican staffers on key congressional health committees say that members pushing forward a Senate “medical innovation” bill and backing “Cures” legislation in the House will not interfere with FDA’s proposed plan to regulate laboratory developed tests before the guidance is made final.
ACLA has recruited Laurence Tribe and Paul Clement, two prominent constitutional legal guns with Supreme Court expertise, to fight FDA over its proposed lab-developed test guidance. The announcement is perhaps the lab industry's most high profile move yet to oppose FDA's plan to regulate lab-developed test services under the device statute with a risk-based phase-in plan.
FDA said its new plan, which can’t be released as a formal draft guidance for another 60 days, would establish a more level playing field between test-kit makers and labs, while being flexible when there is not an FDA-approved alternative to an lab-developed test.