With VALID Act Stalled, Should the FDA Regulate Laboratory-Developed Tests?
Last year, the VALID Act, which would have created a new regulatory framework for Laboratory-Developed Tests that many lab advocates believed to be overly burdensome, stalled out in Congress. Now, some who continue to push for additional oversight for LDTs beyond current CLIA requirements are looking for the FDA to create new regulations through its rulemaking process.
Learn more about the VALID Act and how it would curtail innovative laboratory testing in the private sector.
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Did Government regulations hamper the fight against COVID-19 at a critical juncture? In this short video Roger Klein from Arizona State University Law School, explores the harms caused by government regulation of clinical labs at the start of the pandemic.
Watch this video to see The “Original Sin” of the government’s over-regulation of lab tests at the beginning of the pandemic.
About FDA regulation & Covid-19 Testing
- PolitiFact | Did FDA regulations slow testing for the coronavirus?
- The FDA Is Forcing the CDC to Waste Time Double Testing Some Coronavirus Cases — ProPublica
- The Yale Law Journal – Forum: Deadly Delay: The FDA’s Role in America’s COVID-Testing Debacle
- The CDC’s failed race against covid-19: A threat underestimated and a test overcomplicated – The Washington Post
- Global mortality from the disease has varied dramatically – Washington Post
- We’ll see more shortages of diagnostic tests if the FDA has its way – STAT
- Deadly Delay: The FDA’s Role in America’s COVID-19 Testing Debacle
- The validity of VALID act: Cost modeling cancer diagnostics regulation by the FDA. – Journal of Clinical Oncology
- VALID Act comments from the Association for Molecular Pathology
- Association of Pathology Chairs VALID Act Letter
- New Legislation Would Jeopardize Patient Access to Medical Tests Across the Board by Restricting Policy that Removed Barriers to Coronavirus Testing – AACC
- NILA – The National Independent Laboratory Association – NILA (nila-usa.org)