WASHINGTON, DC – In response to today’s announcement that the Food and Drug Administration (FDA) will release a draft guidance in 60 days to regulate laboratory developed tests (LDTs), the American Clinical Laboratory Association (ACLA) urged the agency to exercise caution, and expressed concern that another layer of regulation could stifle diagnostic innovation and ultimately jeopardize patient access to timely and effective treatments. Historically, ACLA has opposed regulation of LDTs by the FDA, as laboratories are already subject to a comprehensive regulatory framework.
“Laboratories have been regulated for decades by the Centers for Medicare and Medicaid Services (CMS) under the Clinical Laboratory Improvement Amendments (CLIA) and by state law,” said Alan Mertz, President of ACLA. “Under the CLIA framework, a thorough and detailed regulatory process, we’ve seen an explosion of innovation in laboratory diagnostics that has allowed labs to diagnose and measure disease with an accuracy and precision never before possible. This has changed how the medical world views and treats everything from rare diseases to infectious disease to cancer.”
The announcement of the FDA’s intent to issue guidance on the regulation of LDTs is required by the Food and Drug Administration Safety and Innovation Act of 2012 whereby the agency must give Congress 60 days notice and a summary of any such guidance or regulation impacting LDTs.
“The massive leaps in scientific and medical advancement that have occurred over the last quarter century have yielded a bounty of new tests created by highly trained physicians and clinicians that were not even imagined when CLIA was last updated in 1988,” said Mertz. “To the extent that stakeholders have concerns about possible regulatory gaps under CLIA, ACLA has long supported enhancing the CLIA regulatory framework, rather than impose an additional layer of regulation based upon a different statute designed for manufactured products rather than laboratory testing.”
Mertz concluded, “ACLA is reviewing the framework issued by FDA today and will provide comments on the draft guidance after it is published. We are committed to working with the Administration and Congress to ensure that innovation and patient access to the highest quality laboratory diagnostics continues.”