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#Path2Cures Hearing Reviews FDA Proposal for Regulation of Lab Developed Tests

Sep 9, 2014

WASHINGTON, DC - The Subcommittee on Health, chaired by Rep. Joe Pitts (R-PA), today held a hearing in the 21st Century Cures initiative to discuss proposed guidance from the Food and Drug Administration (FDA) regarding the regulation of Lab Developed Tests (LDTs).

"It is indisputable that the draft guidance documents the agency recently released would fundamentally alter the regulatory landscape for the review and oversight of LDTs and the clinical labs that develop them," Pitts explained. While expressing concerns about the process the agency is taking to change longstanding policy, Pitts emphasized, "Any framework adopted must not only prioritize patient safety—which should always be paramount—but also encourage robust investment and allow for continued innovation."

Full committee Chairman Fred Upton (R-MI) added, "We must ensure that our laws and regulations keep pace so that innovation in this space continues and patients benefit from accurate and reliable tests."

Responding to questioning from Rep. Morgan Griffith (R-VA), FDA Director of the Center for Devices and Radiological Health, Dr. Jeff Shuren testified this morning that part of the agency’s reasoning for including a new notification option under the proposed guidance was to allow businesses an opportunity to avoid the health law’s medical device tax. Shuren explained that the new proposal would give businesses an opportunity to avoid the device tax. Shuren told Griffith, "We were trying to give labs a break."

Click to watch Dr. Shuren’s exchange with Rep. Griffith

Witnesses came to the table with varying viewpoints as members sought common ground that can both spur innovation while maintaining the highest level of accuracy and reliability.

Charles Sawyers, M.D. of the American Association for Cancer Research stated, "We are in the midst of an extremely promising age of innovative new cancer treatments. … A robust, predictable, and reliable evidence-based regulatory framework will ensure that these 21st  century cures will reach patients in an efficient and expeditious manner."

Dr. Christopher Newton-Cheh, a cardiologist who appeared on behalf of the American Heart Association, spoke to the rise of personalized medicine and the importance of maintaining a high level of credibility and authenticity when it comes to genetic testing. "The potential for personalized medicine to improve health and improve the practice of medicine is great. Our evolving knowledge of how genes and lifestyle combine to affect our health is transformational. As we continue to develop a greater understanding of the genetics of cardiovascular disease and stroke in particular, we will move away from ‘one-size-fits-all’ medicine to more targeted and effective prevention, treatments, and even cures."

Andrew Fish, executive director of AdvaMed Diagnostics, explained the existing challenges surrounding the regulation of diagnostic tests. "The current diagnostics oversight paradigm results in a tremendous public health gap and highly disparate treatment of tests that are the same from the perspective of patient risk and safety, simply on the basis of whether they are developed by a manufacturer or a laboratory. This is bad public policy, provides an opportunity to use tests in clinical settings that have insufficient clinical data, and stifles investment in high quality products that are assured safe and effective for patients."

Alan Mertz, president of the American Clinical Laboratory Association said, "The documents released by the Agency on July 31, 2014, go far beyond reflecting current Agency thinking, as they propose an entirely new regulatory framework that will be applied to clinical laboratories developing LDTs for the first time. If the FDA were to finalize this guidance, it would represent nothing short of a wholesale reimagining of the regulation of laboratories, subjecting laboratories to an entirely new set of requirements that they have never faced before."

Kathleen Wilsey, Co-Founder of Coalition for 21st Century Medicine added, "We are committed to working with FDA to strike the right balance between assuring public health and facilitating innovation in promulgating flexible regulations for all diagnostic tests—LDTs and IVDs. However, the Coalition is concerned that the proposed framework is incomplete, creates substantial uncertainty, and does not reflect a careful and important balance that recognizes the value and benefits that advanced diagnostics offer to patients, providers, and payers."