WASHINGTON (Jan. 6, 2015)
The Personalized Medicine Coalition (PMC) Executive Vice President Amy M. Miller, Ph.D., issued the following statement today in regards to the House Energy and Commerce Committee’s 21st Century Cures - Request for Feedback: A Modernized Framework for Innovative Diagnostic Tests.
"PMC understands the complexity the community faces regarding the regulation of innovative diagnostics that are the hallmark of personalized medicine. We are committed to working with the Committee on a regulatory structure that supports the understanding and adoption of personalized medicine that will benefit patients and the health system.
"PMC applauds the Committee for addressing this important matter. While FDA has published a proposed framework on the regulation of laboratory-developed tests (LDTs), we believe FDA should outline risk classification for them and the harmonization between the Clinical Laboratory Improvement Amendments (CLIA) program and FDA laboratory inspection.
"We request that FDA publish draft guidance documents that will define risk and the CLIA-FDA harmonization process, and release them in draft for public review as part of an updated framework for regulating LDTs.”
About the Personalized Medicine Coalition:
The Personalized Medicine Coalition (PMC), representing innovators, scientists, patients, providers and payers, promotes the understanding and adoption of personalized medicine concepts, services and products to benefit patients and the health system. For more information about PMC, visit www.personalizedmedicinecoalition.org.