Washington, D.C. – The American Clinical Laboratory Association (ACLA) today issued the following statement after the U.S. Food and Drug Administration (FDA) released a proposed rule that would seek to regulate Laboratory Developed Tests (LDTs) as medical devices under the Federal Food, Drug, and Cosmetic Act. ACLA does not believe that FDA’s actions are in the best interest of patients or our nation’s health care system. Because the proposed rule exceeds FDA’s existing authority, ACLA plans to submit comments urging FDA to withdraw the proposed rule and resume work with Congress, the laboratory community, patient groups, and other stakeholders toward a legislative solution that provides a framework that is appropriate for the unique attributes of LDTs.
“ACLA has long taken the position that FDA does not have statutory authority to regulate LDTs under its medical device authority and strongly opposes unilateral action that exceeds the Agency’s current authority. LDTs are not medical devices. To the extent that FDA secures legislative authority to regulate LDTs, it must be through a regulatory framework that works with, not against, the LDT regulation already in place through the Centers for Medicare & Medicaid Services (CMS) under the Clinical Laboratory Improvement Amendments (CLIA).
Any expansion of FDA’s role in this framework should be tailored by Congress to fit LDTs, just as has been done for food, supplements, drugs, and cosmetics – each of which has a distinct framework suited to the unique characteristics of its category. We also are concerned that FDA is already under resourced and not prepared to complete all of the new work the Agency has now proposed to undertake. FDA seriously risks falling behind on its current public health priorities.
ACLA strongly believes FDA regulation of LDTs could only be done through legislation that establishes a diagnostic-specific, risk-based framework that recognizes the essential role of clinical laboratories in advancing public health, preserving and fostering innovation, and maintaining access to critical testing services that physicians and patients rely on every day.
During the last Congress, ACLA worked collaboratively with bipartisan co-sponsors of the Verifying Accurate Leading-edge IVCT Development (VALID) Act, committees of jurisdiction, FDA, and private sector stakeholders to provide expertise around key provisions of the legislation that resulted in significant improvements in the bill to help protect access and innovation for patients. While VALID was not enacted by Congress last December, ACLA remains committed to working productively with Congress on diagnostic-specific legislation.
Clinical laboratory testing is an essential part of health care that informs 70 percent of health care decisions. Billions of tests are run each year by ACLA member laboratories that are certified under CLIA and accredited by the College of American Pathologists (CAP). These include tests developed during health emergencies like COVID-19 and MPX and for unmet needs. For example, the only clinical tests currently available to detect fentanyl with xylazine are LDTs.
The current system works well for patients and significant changes to the regulatory structure should be done carefully and thoughtfully to avoid unintended consequences that could reduce access to testing, undermine innovation in next generation diagnostics, and increase health care costs.
ACLA believes there remains bipartisan interest in Congress and among key stakeholders to establish a pathway tailored to the dynamic nature of laboratory diagnostics, rather than applying a framework that Congress never intended for this purpose. ACLA urges FDA to resume its work toward a legislative solution. Pursuing a significant change in the regulatory framework without congressional authorization does not benefit patients and risks FDA falling behind on its current public health priorities.”
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The American Clinical Laboratory Association (ACLA) is the national trade association representing leading laboratories that deliver essential diagnostic health information to patients and providers by advocating for policies that expand access to the highest quality clinical laboratory services, improve patient outcomes, and advance the next generation of personalized care.