ACLA Outlines Modern Framework for Diagnostics in Response to 21st Century Cures Initiative White Paper

WASHINGTON, DC – Stating its ongoing commitment to supporting “policies that will ensure robust and undisrupted patient access to innovative, accurate, reliable, and meaningful clinical laboratory diagnostic services,” the American Clinical Laboratory Association (ACLA) cautioned members of Congress spearheading the 21st Century Cures Initiative that Food and Drug Administration (FDA) draft guidance proposing regulation of laboratory developed tests will directly interfere with the practice of medicine and “have potentially harsh impacts on public health.”

“ACLA applauds the foresight of the 21st Century Cures Initiative and the timely endeavor by congressional leaders to explore ways in which physicians, scientists and laboratory clinicians can continue to unlock diagnostic discoveries that bring critical information to practitioners and patients in desperate need of safe and effective therapies,” said Alan Mertz, President and CEO of ACLA. “This is an exciting time in diagnostic innovation and it is essential that legislative and regulatory initiatives put the patient first and avoid placing unnecessary obstacles in the way of access to life-saving treatment.”

In response to a request from House Energy and Commerce Committee Chairman, Rep. Fred Upton, with regard to questions posed in a white paper titled, “21st Century Cures – Request for Feedback: A Modernized Framework for Innovative Diagnostic Tests,” ACLA answered several questions about the potential impact of duplicative and illogical FDA regulation on laboratory developed tests (LDTs).

The ACLA response takes issue with the FDA proposal to regulate LDTs as medical devices pointing out that, “laboratories are not medical device manufacturers at all, and that laboratory-developed testing services simply are not medical devices…” The document goes on to note that, “For decades, Congress and the Administration have recognized that testing laboratories and manufacturers are separate and distinct entities within the health care system.”

The FDA officially issued draft guidance documents outlining its regulatory proposal for LDTs in early October 2014. ACLA announced in November 2014 its retention of attorneys Paul D. Clement, a partner with Bancroft PLLC, and Laurence H. Tribe, the Carl. M. Loeb University Professor and Professor of Constitutional Law at Harvard University, to provide counsel to the clinical laboratory community on all matters relating to the FDA draft guidance.

Characterizing the direct conflict the FDA proposed guidance poses to the goals of the 21st Century Cures Initiative, ACLA offered the following perspective:

“The Food and Drug Administration’s October 3rd, 2014 draft guidance proposals to regulate these laboratory testing services as devices represent direct threats to clinical laboratory innovation and to patient access to such medical services. Rather than improve the public health (as the FDA contends), the draft proposals: 1) are unauthorized by the relevant statutes; 2) represent improper agency encroachment on the practice of medicine; and 3) will harm patient access to vital and innovative clinical laboratory services without offering any clear offsetting benefit. In short, these proposals are starkly contrary to the spirit of the 21st Century Cures Initiative, which seeks to ‘accelerate the pace of cures and medical breakthroughs in the United States,’ not to increase and duplicate costs and regulatory burdens that would pose significant new barriers to medical innovation and to prompt patient access to the benefits of that innovation.”

To view the ACLA’s entire response to the committee’s white paper, click here.

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