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  • Washington Highlights

    AAMC Comments on FDA’s Proposed Guidance on LDTs

    Len Marquez, Senior Director, Government Relations
    Heather Pierce, Senior Director, Science Policy & Regulatory Counsel

    The AAMC Feb. 2 submitted a comment letter to the Food and Drug Administration (FDA) in response to the agency’s draft guidance outlining the plan to regulate laboratory developed tests (LDTs), a subset of in vitro diagnostic devices (IVDs). Although the FDA has held multiple stakeholder workshops and teleconferences to explain the proposed guidance and address questions, concern has continued to grow at academic medical centers that perform these tests in the months following the released guidance [see Washington Highlights, Jan. 9].

    The letter highlights the AAMC’s shared “interest in assuring clinical validity and accuracy of LDTs for diagnostic and treatment decisions,” but urges the FDA to ensure “guidance does not interfere with a vital area of medical practice, negatively impact patients across the country, or create a burdensome, laborious process that could stifle innovations to aide in the treatment of rare and complex diseases.”

    The letter reinforces concerns of AAMC member institutions regarding the number of tests and patients that would be impacted by proposed regulations, given that many large academic hospital laboratories may perform dozens to over a thousand different LDTs. Additionally, the letter urges the FDA to recognize the proposed framework would “greatly slow the rate of clinical innovation that is critical to keeping our healthcare system vital, providing care to patients, and responding quickly to emerging health risks.”

    The AAMC also urges FDA to recognize that LDTs are often “innovative or low-volume tests whose speed of adoption has out-paced the ability of commercial IVD manufacturers to plan and submit formal clinical trials that would be required for FDA approval for marketing,” and adds “if the FDA employs a premarket approval process, the original intent of LDTs will be devastated.”

    Finally, the letter describes the need to clarify and expand the proposed enforcement discretion regarding the outlined “carve-outs,” which include traditional LDTs, unmet needs, and rare diseases, and suggests the FDA rather broaden the categories and situations under which it will exercise its enforcement jurisdiction.