Ranking Member Cassidy Rebukes Biden Admin Attempt to Dramatically Increase FDA Authority over Laboratory Developed Tests

WASHINGTON – Today, U.S. Senator Bill Cassidy, M.D. (R-LA), ranking member of the Senate Health, Education, Labor, and Pensions (HELP) Committee, released a statement on the Food and Drug Administration’s (FDA) final rule to classify Laboratory Developed Tests (LDTs) as medical devices under the Federal Food, Drug, and Cosmetic Act. This policy increases FDA’s regulatory authority and enforcement over LDTs, reducing patient access to critical laboratory tests and undermining future diagnostics innovation. The final rule also exceeds FDA’s statutory authority – Congress has made clear across multiple statutes that LDTs are not medical devices subject to FDA regulation.  

“The FDA does not have the authority to unilaterally increase its regulatory jurisdiction. This rule will undermine access to essential laboratory tests, increase health care costs, and ultimately harm patients. During the pandemic, we saw how too much government interference and red tape delays lifesaving care to Americans,” said Dr. Cassidy. “Congress needs to take action to clarify the regulatory structure for diagnostic tests.” 

Earlier this year, Cassidy requested information from stakeholders on how Congress can improve current regulation of clinical tests, including LDTs, to support innovation while ensuring these products are safe and effective.  

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