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Dear Representatives Walden and Pallone, and Senators Alexander and Murray:
The undersigned organizations represent a diverse and broad community of laboratories, physicians,
and other professional health care providers involved in delivering medical care to millions of patients
daily. As Congress considers legislation focused on oversight of clinical laboratory tests, we urge you to
continue to engage with all stakeholder groups to develop consensus legislation that would modernize
the oversight of laboratory developed testing procedures. The Diagnostic Accuracy and Innovation Act
(DAIA) discussion draft’s approach to regulating laboratory developed testing procedures is not
appropriate as it consequently generates a new regulatory environment that would overburden and
stifle clinical laboratories and medical professionals’ ability to provide laboratory testing to patients. As
drafted, DAIA would sharply curtail medical innovation, which is contradictory to the overwhelming
bipartisan support for the 21st Century Cures Act to advance precision medicine. Precision medicine is
dependent on precision diagnostics—the field of medicine that DAIA is likely to freeze in place.
Laboratory developed testing services and procedures represent an essential component in medical
practice, including infectious disease detection and treatment, newborn screening, inherited disease
testing, and precision medicine in oncology. We stand united in support of modernizing the oversight
framework for high complexity clinical laboratory developed testing procedures but primarily through
reform of the Clinical Laboratory Improvement Amendments (CLIA). We believe that modernization of
CLIA requirements could better achieve a flexible system that fosters innovation and promotes
emerging medical knowledge to enable healthcare professionals the ability to offer precise, accurate,
and the most up-to-date tests to patients. It is also the most streamlined and cost-effective approach,
for both the government and laboratories, and the least disruptive and burdensome approach to
addressing clinical and analytical validity, transparency, and other concerns expressed by interested
stakeholders. Modernizing CLIA oversight will support laboratory advances in clinical care as validated
discovery and innovation continue to develop rapidly.
The creation of a new center at the Food and Drug Administration (FDA), as proposed in the DAIA
discussion draft, to regulate laboratory developed testing procedures is not only unnecessary but also
unrealistic given the current budgetary restraints on the agency. The proposed regulatory approach
could reduce patient access to essential testing services as many community and academic clinical
laboratories would find complying with a new FDA regime cost-prohibitive. This is especially true in an
environment in which deep cuts to Medicare payment for clinical testing, due to the Protecting Access
to Medicare Act of 2014, already threaten patient access to clinical testing services. In short, legislative
and regulatory proposals such as DAIA that shoehorn clinical laboratories into an entirely new regulatory
agency and set of requirements will interject tremendous instability and unpredictability that will harm
access and innovation.
We are sensitive to the concerns expressed by manufacturers of the regulatory paradigm for in vitro
diagnostic test kits (IVDs) as they relate to the length and unpredictable nature of the review processes
at FDA. Many of our members rely on IVDs in their practice and we do support legislative and regulatory
efforts at FDA that would streamline existing pathways for commercially manufactured tests, both to
support the Administration’s priority to reduce unnecessary regulatory burdens and to maintain
innovation of IVDs currently on the market.
We appreciate your leadership and efforts to evaluate and modernize the oversight of laboratory
developed testing procedures and the laboratories in which these clinical testing services and
procedures are performed. All stakeholders on this issue have the same ultimate desired outcome: that
laboratory developed testing procedures continue to be high quality, accurate, and precise as the
science advances and changes while maintaining patient access to these vital procedures. Our
organizations would like to offer our expertise as a resource on this issue, and we hope that moving
forward, all stakeholders will have an equal place at the table for those conversations.
Sincerely,
American Association for Clinical Chemistry
American College of Medical Genetics and Genomics
American Medical Association
American Society for Microbiology
Association for Molecular Pathology
Association of Pathology Chairs
Association of Public Health Laboratories
BioReference Laboratories
Columbia University Irving Medical Center
Emory University Woodruff Health Sciences Center
Infectious Diseases Society of America
Oregon Health & Science University
Pan American Society of Clinical Virology
Stanford University Department of Pathology
University of Chicago Medical Center
University of Washington School of Medicine
Vanderbilt University Medical Center