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Saturday, May 18, 2024

Chair Rodgers Statement on FDA LDT RuleEnergy & Commerce Committee

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Cathy McMorris Rodgers - the Chair of the House Energy and Commerce Committee | Official U.S. House headshot

Cathy McMorris Rodgers - the Chair of the House Energy and Commerce Committee | Official U.S. House headshot

House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA) expressed strong concerns over the Food and Drug Administration's (FDA) final rule on lab-developed tests (LDT). In a statement, Chair Rodgers criticized the rule, stating, "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."

Chair Rodgers further highlighted that while the final rule showed some improvement from the proposed version, she believes it will still have negative consequences. She noted, "it will still increase costs and decrease access to diagnostics and medical tests that provide information crucial for doctors to treat their patients effectively."

During a recent hearing, concerns were raised about the potential harmful effects of the rule on patient care and diagnosis. Chair Rodgers emphasized that finalizing the rule goes against President Biden's objective of reducing cancer deaths. She concluded by calling for the FDA to abandon the rule, citing a lack of clear statutory authority for its implementation.

The Energy and Commerce Subcommittee on Health previously convened a hearing on March 21, 2024, to explore different approaches to LDT regulation. For more information, interested parties can contact the House Energy and Commerce Committee at (202) 225-3641 or reach out to the press office at (202) 226-4972.

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