ACLA Evaluating Draft FDA Guidance Documents, Calls on Administration to Work with Congress and Stakeholders on Comprehensive Diagnostic Reform

(WASHINGTON, DC) – The American Clinical Laboratory Association (ACLA) – the nation’s largest organization representing the public policy interests of clinical laboratories – called on the Administration to work with Congress and clinical laboratory stakeholders on comprehensive diagnostic reform in the wake of last night’s release of two new draft FDA guidance documents on Next Generation Sequencing (NGS), a method for performing genetic tests.

“ACLA supports the spirit of the President’s efforts to advance precision medicine,” said Alan Mertz, President of ACLA. “However, ACLA continues to assert that laboratory developed tests (LDTs) are not medical devices, including those LDTs that utilize NGS technology.  While we recognize the FDA is looking for innovative solutions, these proposals show the inherent difficulty of attempting to shoehorn LDTs into medical device standards.”

The FDA has issued numerous proposals and statements in recent years threatening to mandate medical device standards for LDTs on top of federal standards for clinical laboratories already existing under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), which are administered by the Centers for Medicare and Medicaid Services (CMS).  Both the House Energy & Commerce Committee and the Senate Committee for Health, Education, Labor & Pensions have signaled their interest in reforming the statutes in this area, with Energy & Commerce releasing a discussion draft to this effect last October.

“ACLA has been working in a bipartisan fashion with Congress and other stakeholders on proposals to update decades-old laws, to ensure that clinical laboratory innovation continues and that patients have robust access to these advances.  We respectfully call on the Administration to engage fully and transparently in this process so that we can achieve true statutory reform that benefits patients.  The time is now, let’s work together.”

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The ACLA is a not-for-profit association representing the nation’s leading national, regional and esoteric clinical laboratories on key issues of common concern, including federal and state government reimbursement and regulatory policies.

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