publication date: May. 11, 2018

Health groups urge Congress to modernize regulation of diagnostics

Health care organizations and companies 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 and the House Energy and Commerce Committee, more than 80 organizations urged Congress to prioritize meaningful diagnostic oversight reform in 2018, including for laboratory developed tests and in vitro diagnostics.

“Diagnostics reform is a bipartisan, bicameral issue that has the support of the FDA, making it a suitable issue to be completed in 2018,” the groups wrote. “Stakeholders have never been more aligned on the need for diagnostics reform than we are now. As stakeholders, we stand ready to continue the work necessary to finalize a consensus diagnostics reform package this year.”

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, according to the American Cancer Society Cancer Action Network. The letter May 9 comes on the heels of recent public comments from FDA Commissioner Scott Gottlieb, who said comprehensive legislative action on clinical laboratory diagnostics would be 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,” Julie Khani, president of the American Clinical Laboratory Association, said in a statement. “To deliver on that promise without disrupting patient access, we urge Congress to prioritize diagnostic reform … Continue reading Health groups urge Congress to modernize regulation of diagnostics

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