Westbank Louisiana News

WASHINGTON – U.S. Senator Bill Cassidy, M.D. (R-LA), the ranking member of the Senate Health, Education, Labor, and Pensions (HELP) Committee, has criticized the Food and Drug Administration’s (FDA) final rule regarding Laboratory Developed Tests (LDTs). The rule aims to classify LDTs as medical devices under the Federal Food, Drug, and Cosmetic Act, thereby increasing FDA's regulatory authority and enforcement over these tests.

In a statement, Dr. Cassidy expressed his concerns, stating, "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."

Dr. Cassidy emphasized the need for congressional action to clarify the regulatory structure for diagnostic tests, highlighting the potential negative impact of the FDA's expanded authority on patient access to critical laboratory tests and future diagnostics innovation.

Earlier this year, Cassidy had sought input from stakeholders on how Congress can enhance the current regulation of clinical tests, including LDTs, to promote innovation while ensuring the safety and effectiveness of these products.

For more news and updates from HELP Republicans, interested individuals can visit the committee's website or follow them on Twitter at @GOPHELP.