U.S. Health and Human Services Decision to Strip FDA Oversight of Laboratory Developed Tests Puts Americans at Risk

August 21, 2020

WASHINGTON, D.C. – U.S. Department of Health and Human Services (HHS) announced their decision Wednesday to rescind all guidance related to U.S. Food and Drug Administration (FDA) oversight of laboratory developed tests (LDTs), a move that could have broad, negative health consequences.

The following is a statement from Lisa Lacasse, president of the American Cancer Society Cancer Action Network (ACS CAN).

“FDA has long assumed authority over laboratory developed tests (LDTs), which ACS CAN has supported. Molecular tests have become essential tools in the delivery of 21st century medicine, helping to diagnose patients, providing prognostic information, guiding therapy selection and helping to monitor disease trajectory. Accuracy and reliability of diagnostic tests are the bedrock of any personalized care and are especially important in cancer where test results often drive life or death treatment decisions.

“FDA has been judicious in its intervention with LDTs, providing a largely hands-off approach while addressing dangerous tests and bad actors. Preventing FDA from exercising oversight over LDTs, especially during a pandemic, creates an environment where consumers may receive inaccurate test results, or worse be subjects of fraudulent testing, potentially diminishing faith in the diagnostic testing ecosystem.

“ACS CAN, along with a broad spectrum of public health groups and stakeholders, has repeatedly called for updating diagnostic oversight, not dismantling it. HHS’s decision to remove FDA’s oversight is a step in the wrong direction and one that could lead to serious consequences for patients.”

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