Washington, D.C. - Leading health care companies and organizations representing patients, providers, laboratories and diagnostic manufacturers called on Senate and House leaders to advance legislation that would reform and modernize the process for bringing innovative diagnostics and clinical laboratory tests to market. In a letter to the Chairmen and Ranking members of the Senate Committee on Health, Education, Labor & Pensions (HELP) and House Energy and Commerce Committee, more than 80 organizations urged Congress to prioritize meaningful diagnostic oversight reform in 2018, including for laboratory developed tests (LDTs) and in vitro diagnostics (IVDs).
The call for action represents the first time manufacturers, providers, labs, and patient groups have come together to make a collective push for clinical diagnostic regulatory reform and comes on the heels of recent public comments from Food and Drug Administration (FDA) Commissioner Scott Gottlieb stating comprehensive legislative action on clinical laboratory diagnostics is timely and appropriate.
“We all share the goal of accelerating development of and access to new, ground-breaking medical advances that have the potential to greatly improve patient health and well-being,” said Julie Khani, President of the American Clinical Laboratory Association. “To deliver on that promise without disrupting patient access, we urge Congress to prioritize diagnostic reform this year and help ensure a sustainable path for future diagnostic innovation.”
Prioritizing diagnostic reforms this year would build on efforts from both Committees as well as the work from Reps. Larry Bucshon (R-IN) and Diana DeGette (D-CO) who released the Diagnostic Accuracy and Innovation Act (DAIA) discussion draft. The discussion draft contemplates a host of policies which are important for stakeholders to consider for a modernized diagnostic framework.
Currently, conflicting regulatory standards and oversight between the FDA and the Centers for Medicare and Medicaid Services (CMS) have significantly slowed progress in bringing new, ground-breaking diagnostic tests to market. Stakeholders have consistently called on Congress to reform regulatory responsibilities between the two primary agencies with a modernized framework for diagnostic oversight.
“For patients and their families, a diagnostic test is often the first step towards a treatment plan that can attack cancer at its core, and accurate and reliable diagnostics are necessary to make the best decisions,” said Christopher Hansen, President of the American Cancer Society Cancer Action Network. “Diagnostic reform is not only essential for care delivery today, but it will serve as the backbone for ensuring that patients continue to benefit from ever more personalized therapies going forward.”
"Innovative medical diagnostics tests and technologies are the foundation for evidence-based medicine, allowing for early intervention that improves patients' health outcomes, often lowering costs for the broader health system. A modernized and predictable, risk-based, diagnostics regulatory framework would speed the pace and reach of cutting edge diagnostics, allowing patients to benefit more broadly and rapidly from breakthrough diagnostic technologies," Susan Van Meter, Executive Director of AdvaMedDx, said. “Now is the time for Congress to advance needed diagnostic reforms.”
“A more streamlined and modernized regulatory approach to diagnostics and clinical lab tests will open the door to a new era of medicine and cancer care,” Jeff Allen, President and CEO of Friends of Cancer Research, said. “We applaud Congressional leaders who have already made progress in advancing common-sense policy changes and look forward to working with policymakers in both parties to make diagnostic reform a reality.”
###