WASHINGTON, D.C. – Yesterday, Senators Richard Burr (R-NC), Michael Bennet (D-CO), and Orrin Hatch (R-UT) introduced a bipartisan bill, the Advancing Breakthrough Devices for Patients Act, to help bring breakthrough devices to patients in as timely a manner as possible.
The Advancing Breakthrough Devices for Patients Act builds on legislation, the Advancing Breakthrough Therapies for Patients Act, that the Senate passed in 2012 from Senators Bennet, Hatch, and Burr. Both the 2012 legislation and the newly introduced bill share similar principles, such as an “all hands-on-deck” approach to devices, while also complementing and enhancing the existing tools, such as priority review, currently in place for devices, with the goal of expediting the development and review of breakthrough products.
“Americans ought to benefit from the latest life-saving research and innovative devices developed by the medical community, and this measure ensures FDA can give a helping hand. By streamlining the approval process and improving regulatory certainty, we’re giving more patients a fighting chance to improve their lives," said Hatch.
“America is the world’s most innovative nation, especially in our medical research and development. America's patients deserve access to the latest, most cutting-edge life-saving therapies and devices, and we need to advance these innovative medical products, including breakthrough devices. FDA can be a key partner in this important endeavor,” said Burr. “This legislation ensures that America’s patients are receiving the most innovative technologies in as timely a manner as possible by improving regulatory certainty and applying an all-hands-on-deck approach to the development and review of these devices. I am excited to see this legislation move forward with the help of my two trusted colleagues, Senators Bennet and Hatch.”
“Medical innovation is helping drive Colorado’s economy, and it’s improving the lives of patients across the country,” Bennet said. “This bill helps create a system that will spur this type of innovation and ensure patients have access to potentially lifesaving breakthrough medical devices. It complements the highly successful Breakthrough Therapies program we passed with the help of Senators Burr and Hatch by streamlining the review process and ensuring the most effective and safe devices are helping patients.”
Text of the Advancing Breakthrough Devices for Patients Act can be found here, while a one pager on the legislation can be found here.
