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  • Washington Highlights

    Energy and Commerce Health Subcommittee Hearing on Regulation of Diagnostic Tests

    Len Marquez, Senior Director, Government Relations

    The House Energy and Commerce Subcommittee on Health Nov. 17 held a hearing on the regulation of laboratory-developed tests (LDTs). Food and Drug Administration (FDA) Director for the Center for Devices and Radiological Health Jeffrey Shuren, M.D., J.D., and Centers for Medicare and Medicaid Services (CMS) Deputy Administrator and Chief Medical Officer for Innovation and Quality Patrick Conway, M.D., provided testimony.

    Currently, CMS regulates laboratories performing such tests through the Clinical Laboratory Improvement Amendments (CLIA), with state laboratory certification programs and professional accrediting bodies providing additional regulation. The FDA has consistently maintained that it has the authority to regulate LDTs and is now proposing to cover LDTs under a risk-based regulatory framework, much like the approach it employs for other diagnostic tests and medical devices.

    The committee examined the regulation of diagnostic tests and laboratory operations as part of its 21st Century Cures initiative and put forth a December 2014 white paper soliciting stakeholder feedback titled, “A Modernized Framework for Innovative Diagnostic Tests,” and discussion draft legislation released in late October 2015. Throughout the 21st Century Cures legislative process, questions of the need to increase regulatory oversight of LDTs garnered much attention from the FDA, CMS, and interested stakeholders.

    In his opening statement, Subcommittee Chair Joe Pitts (R-Pa.) said that in order to advance many concepts included in the 21st Century Cures initiative, “we must establish a regulatory environment that fosters the development of and access to innovative, accurate and reliable diagnostic testing.” He added that LDTs are “increasingly important” to the diagnosis and treatment of certain diseases and conditions, but expressed concerns regarding the lack of regulation and oversight of such tests.

    Ranking Member Frank Pallone (D-N.J.) echoed similar concerns stating, “Many of these tests have not been reviewed or cleared by FDA prior to coming to the market to confirm that these tests are accurate, reliable, or provide clinically accurate results. This can result in patients going undiagnosed with certain medical conditions, or undergoing treatment that is not medically necessary.”

    Dr. Shuren outlined the FDA’s proposed framework to regulate diagnostic tests including in vitro diagnostic devices (IVDs), emerging diagnostic technologies like “next-generation DNA sequencing devices,” and LDTs. The draft guidance proposes a phase-in enforcement of premarket review requirements to ensure clinical validity, particularly for higher-risk LDTs.

    Dr. Shuren added, “The FDA is committed to developing a final policy for oversight of LDTs that encourages innovation, improves patient outcomes, and strengthens patient confidence in the reliability of these products.”

    Dr. Conway echoed similar regulatory goals stating, “CMS is committed to ensuring high quality, accurate, and reliable laboratory testing by assuring that laboratories have appropriate controls, expertise, training, and procedures.” He added, “We believe CLIA and our implementing regulations create the necessary framework to effectively oversee laboratory’s day-to-day operations…including those operations that pertain to the use of high-complexity tests, including LDTs.”

    Questions from committee members focused on the appropriate level of regulation over LDTs, agency jurisdiction to regulate such tests, and if legislation is needed to limit or increase regulating powers.