ACLA Joins Physicians, Hospitals and Provider Stakeholders in AMA Letter Requesting FDA Withdraw Proposed Draft Guidance to Regulate Laboratory Developed Tests (LDTs)

WASHINGTON D.C. – The American Clinical Laboratory Association (ACLA) applauded the American Medical Association (AMA) today for its leadership in garnering the signatures of more than 50 physician, hospital and clinical lab stakeholders on a letter sent to Food and Drug Administration (FDA) Commissioner Margaret Hamburg challenging the agency’s decision to issue draft guidance to regulate laboratory developed tests (LDTs) and noting that the “overwhelming weight of legal authority dictates that the proposed new requirements outlined in the draft guidance must be issued through notice and comment rulemaking.”

“The long list of highly respected physician and hospital organizations and clinical laboratories that signed the AMA letter is indicative of broad opposition to the FDA’s insistence on sidestepping requirements set forth in the Administrative Procedures Act (APA) by issuing draft guidance for LDT oversight rather than abiding by the notice and comment rulemaking procedure,” said Alan Mertz, President of the ACLA.

The letter also notes:

“Protections afforded by the notice and comment rulemaking process include the requirement that the Agency respond to all stakeholder comments and undertake an economic impact analysis of the new regulatory oversight to assess the estimated burden on the regulated. The foregoing are critical exercises to address widely-held concerns with the lack of specificity and clarity in the proposed guidance that undermine the ability of impacted stakeholders to provide constructive and informed feedback on the proposed changes.”

“ACLA strongly believes the FDA lacks the statutory authority to regulate LDTs,” said Mertz. “Patients remain the priority for the clinical laboratory community and crippling their access to diagnostic discoveries by stifling innovation with layers of redundant regulation ultimately jeopardizes lives.”

The ACLA, also a signer on the letter to Commissioner Hamburg, recently announced the hiring of attorneys Paul Clement and Laurence Tribe, two of the nation’s most preeminent experts in constitutional law and administrative procedure, to represent the clinical laboratory community on matters relating to the FDA’s proposed guidance to regulate LDTs.


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