Chair Rodgers Statement on FDA LDT Rule

Washington, D.C. -House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA) issued the following statement after the Food and Drug Administration (FDA) issued a final rule regarding the regulation of lab-developed tests (LDT):

"The Biden administration's final rule is the latest example of executive branch overreach that will have devastating impacts on patients and families across the country," said Chair Rodgers. "While the final rule is a slight improvement to the proposed rule, it will still increase costs and decrease access to diagnostics and medical tests that provide information crucial for doctors to treat their patients effectively. At a recent hearing, we heard testimony about the harmful impact the rule will have on diagnosing and caring for patients. Moreover, finalizing this rule is inconsistent with President Biden's goal of reducing cancer deaths. The FDA should abandon the rule, as it lacks the clear statutory authority to implement it."

NOTE: The Energy and Commerce Subcommittee on Health held a hearingon March 21, 2024, to discuss various approaches to LDT regulation.