"Precision Medicine" Guidance Requirements Promise to Clarify Approval Process for Personalized Medicine Products
WASHINGTON (July 10, 2015)
The Personalized Medicine Coalition (PMC) applauds today’s passage of the "21st Century Cures Act” by the United States House of Representatives, which promises to help incentivize personalized medicine by requiring FDA to issue guidance on the development of personalized medicine products and providing additional funds for the National Institutes of Health (NIH) and FDA to support innovative research and development.
The personalized medicine guidance provisions follow PMC’s recommendation that the bill incentivize personalized medicine by creating a transparent, stable and predictable regulatory environment for developing personalized medicine products, which was included in the Coalition’s letter to the bill’s authors in June of 2014.
PMC President Edward Abrahams, who participated in a roundtable discussion on personalized medicine during the early stages of the 21st Century Cures effort, said the requirements would advance the field.
"Progress in personalized medicine is not automatic,” Abrahams said. "Its promise of improved outcomes for patients and a more efficient health care system will only be realized if those championing it have confidence that regulatory and reimbursement policies encourage its adoption. By requiring that FDA clarify its plans for ensuring the advancement of the field and authorizing new funds for NIH and FDA, these provisions are a significant step toward that end.”
PMC is now turning its attention toward amplifying the personalized medicine conversation in the Senate. At the request of Sen. Amy Klobuchar (D-MN), the Coalition has organized a personalized medicine Hill briefing for this Thursday, July 16, from 12:00 - 1:30 p.m. ET. The briefing is co-hosted by Sens. Klobuchar and Orrin Hatch (R-UT), and will take place in the Kennedy Caucus Room of the Russell Senate Office Building.
About the Personalized Medicine Coalition:
The Personalized Medicine Coalition, 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, please visit www.personalizedmedicinecoalition.org.