Press Releases

Burgess Statement on FDA's Laboratory Developed Test Decision

Washington, D.C. Congressman Michael C. Burgess, M.D. (R-TX), Chairman of the House Energy and Commerce Subcommittee on Commerce, Manufacturing and Trade, issued the following statement in response to the announcement from the Food and Drug Administration (FDA) that it will not issue a final guidance to regulate laboratory developed tests (LDTs). 

"I agree with the FDA’s decision not to move forward with this guidance.  21st Century medicine should not rely on trial-and-error, and unnecessary burdensome regulation of laboratory tests could send us back to the dark ages. As our country seeks to harness the value of precision medicine, we must not obstruct access to tools that enable clinicians to target treatment based on the personal profile of each individual patient. I am confident that the House Committee on Energy and Commerce will continue to engage with patients, providers, clinical labs, researchers, and the rest of the medical community to ensure federal policies allow diagnostic innovation to advance the state of health care for all Americans."