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House Subcommittee Discusses FDA Guidance on LDTs

September 12, 2014—The House Energy and Commerce Subcommittee on Health Sept. 9 held a hearing titled, “Examining the Regulation of Laboratory Developed Tests,” in response to recent guidance offered by the Food and Drug Administration (FDA) regarding the regulation of Lab Developed Tests (LDTs). The hearing was part of the committee’s 21st Century Cures initiative series.

Academic and research laboratories develop and use LDTs to diagnose rare diseases in a subset of the population. Recently with the popularity of direct-to-consumer (DTC) genetic testing, LDTs have been utilized to test for relatively common diseases and are reaching more of the general population.

In response, the FDA July 31 notified Congress of its intent to issue two draft guidance documents regarding oversight of LDTs and provided the anticipated details in guidance format. Currently, the Centers for Medicare and Medicaid Services (CMS) regulates LDTs under the Clinical Laboratory Improvement Amendments (CLIA) of 1988. The FDA notification explained that “due to changes in the complexity and use of LDTs and the associated increased risks, FDA believes the policy of general enforcement discretion towards LDTs is no longer appropriate.”

The FDA notice also points out that “Although the CLIA requirements are essential for ensuring that laboratories and their personnel maintain standards of high quality, FDA is concerned that compliance with CLIA regulations alone does not ensure that the diagnostic devices themselves are safe and effective as required by the Federal Food, Drug, and Cosmetic Act (FD&C Act).”

Opening the hearing, Health Subcommittee Chair Joe Pitts (R-Pa.) stated the draft guidance documents suggested by the FDA would “fundamentally alter the regulatory landscape for the review and oversight of LDTs and the clinical labs that develop them.” Commenting on the impact of the increased regulation, Chairman Pitts added, “It is also indisputable that innovative laboratories and health care providers develop and perform tests and procedures that advance personalized patient care. Because of the critical role they can play in the decisions patients make with their doctors, these tests—regardless of who develops or manufactures them—must be accurate and reliable. Any framework adopted must not only prioritize patient safety—which should always be paramount—but also encourage robust investment and allow for continued innovation.”

Health Subcommittee Ranking Member Frank Pallone (D-N.J.) highlighted both the challenges and opportunities LDTs pose saying, “New technologies and advances in medicine can improve the quality of life for millions of Americans, but the use of these advances can also pose serious risk to individual patients if they’re not clinically accurate. And this is why we have regulation and it’s why the FDA has proposed comments since changes that merely bring safety regulations up to speed with medical progress.”

Jeffrey Shuren, M.D., J.D., FDA Center for Devices and Radiological Health director, explained that the FDA understood the concerns with their proposal to begin LDT regulation stating, “FDA recognizes the importance of implementing a balanced approach that fosters the development of new and innovative tests while ensuring appropriate patient protections…We believe the tailored framework we intend to  propose would strike the right balance by providing a risk-based, focused approach to the oversight of those LDTs that pose greater risk to patients, and that would phase in review for this subset of LDTs over time.” 

A second panel provided testimony from additional stakeholders including the American Heart Association, American Clinical Laboratory Association, and American Association for Cancer Research.


Heather Pierce, JD, MPH
Sr. Director, Science Policy & Regulatory Counsel
Telephone: 202-478-9926

Dave Moore
Senior Director, Government Relations
Telephone: 202-828-0559

Len Marquez
Director, Government Relations
Telephone: 202-862-6281


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