HHS blocks FDA from regulating lab-developed tests

Maia Anderson –
Friday, August 21st, 2020

HHS has actually obstructed the FDA from regulating many laboratory tests on the market in a move that some public health specialists say could cause unreliable COVID-19 tests..

In a policy modification, HHS said the FDA can not regulate tests that are developed by and utilized at labs managed under the Clinical Laboratory Improvement Amendments program, which is supervised by CMS. Such laboratories are in huge academic medical centers, smaller business laboratories and bigger testing business, such as Quest Diagnostics and LabCorp, according to The Washington Post..

Tests made by one business, such as Roche or Abbott, and sold to labs and other companies arent affected by the policy modification and can still be managed by the FDA..

Fans of the modification argue it might assist get brand-new and more innovative tests to market quicker and say the FDAs review process slowed evaluating down at the beginning of the pandemic. Labs have actually argued that if they had not had to submit applications to the FDA for their tests, the U.S. would have been able to broaden testing previously in the pandemic..

HHS authorities informed the Post that lab-developed tests still will be regulated by CMS which the FDA will still have the authority to take a bad test off the marketplace. The authorities stated the FDA can just get authority to regulate lab-developed tests through a formal rulemaking process or legislation, which is unlikely to happen soon..

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HHS stated the change, revealed Aug. 19, was produced legal reasons due to the fact that the FDA does not have the authority to control lab-developed tests, which make up a significant portion of tests on the marketplace..

An FDA spokesperson decreased to comment to the Post on the concern and referred concerns to HHS..

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Some public health professionals state the modification is not likely to solve current screening issues, mostly triggered by shortages of products such as swabs and chemical reagents, according to the Post..

Dr. Hahn has actually argued that the FDA has the authority to regulate lab-developed tests throughout public health emergencies such as the COVID-19 pandemic..

The policy change was a surprise to numerous at the FDA, the Post reported, and it has actually been a point of difference in between HHS Secretary Alex Azar and FDA Commissioner Stephen Hahn, MD..