On August 19 the U.S. Department of Health and Human Services, in line with Trump administration executive orders, announced that the Food and Drug Administration will no longer regulate certain laboratory tests, including some tests used to diagnose COVID-19.
The move, which affects tests developed and used by labs regulated under the Clinical Laboratory Improvement Amendment program overseen by HHS’s Centers for Medicare and Medicaid Services, is “strongly opposed” by the FDA, according to a report from The Washington Post. Affected laboratories include commercial laboratories such as Quest and LabCorp as well as those at academic medical centers.
In contrast, tests manufactured by one company — such as Roche or Abbott — and sold to labs and other firms are still regulated by the FDA and aren’t affected by the change.
According to the HHS announcement, although affected labs are no longer required to seek FDA clearance, approval or emergency use authorizations for their tests, they may voluntarily continue to do so.
Making and selling tests to the public without FDA review has some health experts concerned about testing accuracy, as reported by CNN.
"Basically, these are things that are done in individual labs -- almost like boutique testing -- and then you have a worry that they're not going to be very accurate or that people will cut corners knowing that no one is looking over their shoulder to check their test," Dr. Art Caplan, founding head of the Division of Medical Ethics at NYU School of Medicine, told CNN.
Others applaud the change. Supporters assert that new and innovative tests may become available more rapidly when freed from the FDA review process, which some believe slowed COVID-19 testing at the onset of the pandemic, as reported by The Washington Post.
This policy change sparked heated disagreements between HHS Secretary Alex Azar and FDA Commissioner Dr. Stephen Hahn in recent weeks. Hahn argued that it is one of the FDA’s roles to regulate lab-developed tests during the COVID-19 pandemic, also via The Washington Post.
How To Report Problems with COVID-19 Tests
The FDA encourages reporting of suspected problems with COVID-19 diagnostic tests through the agency’s MedWatch Voluntary Reporting Form.