ACLA Urges Congressional Leaders to Advance New Regulatory Framework for Diagnostic Tests

In Comments to Congress, ACLA Cites Concerns with the FDA’s New Proposals for Diagnostic Reform

Washington, D.C. – Today, the American Clinical Laboratory Association (ACLA) calls on Congressional leaders to enact a distinct regulatory framework for diagnostics – a key goal outlined in comments to Reps. Larry Bucshon (R-IN) and Diana DeGette (D-CO), and Sens. Orrin Hatch (R-UT) and Michael Bennet (D-CO). The comments come in response to Technical Assistance (TA) provided to Congress by the Food and Drug Administration (FDA) on Bucshon and DeGette’s discussion draft, the Diagnostic Accuracy and Innovation Act (DAIA).

While the FDA’s TA represents an important milestone in the broader diagnostic reform process, the agency’s proposals raise a range of regulatory concerns and questions. Importantly, these proposals would fail to support a sustainable regulatory framework and undermine the balance needed to support innovation and assurances for accuracy and reliability. As a result, ACLA believes the framework set forth in the DAIA Discussion Draft should be the starting point for diagnostic reform discussions in Congress.

“The diagnostic community, including clinical laboratories, have put in great effort to move the debate over reforming diagnostic oversight as far as it has come today,” President Julie Khani stated. “The FDA TA is another significant step in this process, but a number of the agency’s proposals create genuine concern.  Within the Committee and legislative processes of Congress, we are confident we can achieve a balance among all stakeholders to maintain robust patient access to innovative and high quality laboratory tests. ACLA respectfully urges Congress to take up diagnostic reform and work with all stakeholders to achieve our mutual goals.”

To view the full comment letter, click here.

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