AMP, other stakeholders urge Congress to pause FDA LDT rule, update CLIA

Washington Dc Capitol Social

In a letter addressed to Sens. Bernie Sanders and Bill Cassidy, chair and ranking member, respectively, of the U.S. Senate Committee on Health, Education, Labor and Pensions, and Reps. Cathy McMorris Rodgers and Frank Pallone, chair and ranking member, respectively, of the House Energy and Commerce Committee, the Association for Molecular Pathology (AMP) requested Congress to update the Clinical Laboratory Improvement Amendments (CLIA) as an alternative to the U.S. Food and Drug Administration’s (FDA’s) proposed rule to increase agency oversight of laboratory-developed tests (LDTs).

“We believe that the modernization of CLIA requirements could better achieve a sustainable system that fosters innovation and promotes emerging medical knowledge to enable healthcare professionals the ability to offer precise, accurate, and the most up-to-date tests to patients,” AMP wrote in the letter, which was co-signed by other stakeholders, including more than 50 organizations and institutions.

The letter urges the lawmakers to “direct the FDA to pause rulemaking on LDTs and instead, renew bipartisan efforts to work with stakeholders to pass legislation that would establish a modernized approach within the existing regulatory framework under CLIA.”

The proposed rule has garnered a strong response from other organizations. The deadline for the FDA’s comment period is December 4.

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