ACLA in Comment Letter: FDA Lacks Statutory Authority in Ill-Advised Move to Regulate Laboratory Developed Tests (LDTs) As Devices

WASHINGTON, DC – The American Clinical Laboratory Association (ACLA) today submitted comments to the Food and Drug Administration (FDA) addressing FDA’s draft guidance to newly regulate laboratory developed tests (LDTs), stating the agency lacks the statutory authority to regulate LDTs, is misguided in its attempt to define diagnostic testing services as medical devices and will duplicate existing regulation while hampering innovation.

“The clinical laboratory industry emphatically maintains that the FDA lacks the statutory authority to regulate laboratory developed testing services and likens its attempt to define a lab test as a medical device to trying to fit a round peg into a square hole,” said Alan Mertz, President of the ACLA. “FDA’s attempted expansion of its authority is inconsistent with the statutory text and would raise serious constitutional questions that Congress itself sought to avoid when crafting the current regulatory framework for LDTs.”

Laboratory developed testing services are diagnostic tests that are developed, validated, and performed by highly-trained professionals within a single clinical laboratory entity. LDTs have been comprehensively regulated by CMS, which administers the detailed requirements Congress enacted under the Clinical Laboratory Improvements Act (CLIA), as well as by state regulators. Physicians routinely depend on LDTs for critical information in making crucial medical decisions about the best course of treatment for their patients. The FDA issued its draft guidance to newly regulate LDTs in October 2014, with the stakeholder comment period ending today, February 2, 2015.

“Physicians rely on laboratory developed testing services, ranging from common tests such as pap smears and gram stains, to the most advanced and sophisticated molecular and genetic sequencing tests for cancer, heart disease, and rare infectious diseases, said Mertz. “Molecular diagnostics have ushered in a new era of personalized medicine and will continue to advance treatment options for patients anxiously holding onto hope. This is science at its best – helping mankind.”

Noting Congress’ intent when it passed CLIA, ACLA’s comments include the following passages:

“The statutory definition of a ‘device,’ and the legislative history of the 1976 Medical Device Amendments and the Clinical Laboratory Improvement Amendments, demonstrate that Congress did not intend for FDA to regulate laboratory developed testing services. If FDA did have the authority to regulate these services, it would have to do so through notice-and-comment rulemaking, rather than through its relatively informal guidance process. That is because FDA intends to impose novel binding obligations on the public and on the Agency itself…”

“Laboratory developed testing services are not physical ‘articles,’ much less articles moving in commerce, and are categorically different from the items Congress enumerated as ‘devices.’ Shoe-horning proprietary methodologies and processes into a list that includes only tangible articles would contravene the basic rule of construction that ‘words…are known by their companions.’ Laboratory developed testing services do not become medical devices merely because they sometimes utilize other medical devices.”

Noted Mertz, “The medical community has experienced an innovation explosion over the last several decades that has had a global impact on disease intervention and cures. Laboratory developed tests are at the forefront of medical discoveries that are changing and saving the lives of patients around the globe. Our concerns about the FDA’s draft guidance to regulate LDTs is not just about lacking statutory authority and calling a test a device. The impact of FDA regulation could put the brakes on medical progress and alter a future where cures for diseases become commonplace.”


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