HHS blocks FDA from regulating lab-developed tests

HHS has blocked the FDA from regulating many laboratory tests on the market in a move that some public health experts say could lead to unreliable COVID-19 tests. 

In a policy change, HHS said the FDA cannot regulate tests that are developed by and used at labs regulated under the Clinical Laboratory Improvement Amendments program, which is overseen by CMS. Such labs are in big academic medical centers, smaller commercial labs and bigger testing companies, such as Quest Diagnostics and LabCorp, according to The Washington Post

Tests made by one company, such as Roche or Abbott, and sold to labs and other firms aren't affected by the policy change and can still be regulated by the FDA. 

HHS said the change, announced Aug. 19, was made for legal reasons because the FDA lacks the authority to regulate lab-developed tests, which make up a significant portion of tests on the market. 

Supporters of the change argue it could help get new and more innovative tests to market quicker and say the FDA's review process slowed testing down at the beginning of the pandemic. Labs have argued that if they hadn't had to submit applications to the FDA for their tests, the U.S. would have been able to expand testing earlier in the pandemic. 

But some public health experts say the change is unlikely to solve current testing problems, largely caused by shortages of supplies such as swabs and chemical reagents, according to the Post

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

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

HHS officials told the Post that lab-developed tests still will be regulated by CMS and that the FDA will still have the authority to take a bad test off the market. The officials said the FDA can only get authority to regulate lab-developed tests through a formal rulemaking process or legislation, which is unlikely to happen soon. 

An FDA spokesperson declined to comment to the Post on the issue and referred questions to HHS. 

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