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AdvaMed Statement on Revised 21st Century Cures Draft
WASHINGTON, D.C. – Stephen J. Ubl, president and CEO of the Advanced Medical Technology Association (AdvaMed), issued the following statement today on the release of a revised discussion draft of legislative proposals for the House Energy and Commerce Committee’s 21st Century Cures initiative:
“AdvaMed commends Chairman Fred Upton (R-Mich.) and Representatives Diana DeGette (D-Colo.), Frank Pallone (D-N.J.), Joe Pitts (R-Pa.), and Gene Green (D-Texas) for their leadership on exploring ways to accelerate the discovery, development and delivery of new treatments and cures in the U.S. This is an issue that affects every American family, and the strong bipartisan support for moving forward is heartening.
While we are still reviewing the details of the committee’s revised discussion draft, we are pleased it includes a number of proposals to improve the innovation ecosystem that supports the development of life-saving, life-enhancing medical technology.
“The draft includes key improvements to FDA’s premarket program for medical devices – most significantly the establishment of an expedited pathway for breakthrough, innovative technologies – which will increase the efficiency, predictability and transparency of the agency’s review process and improve patient access to the best in medical progress.
“We also appreciate the committee’s inclusion of significant regulatory reforms and increased NIH funding which will help strengthen our U.S. R&D infrastructure.
“While these proposals are important, we encourage the committee also to consider additional reforms that address Medicare coverage and payment challenges that restrict access to new technologies that improve patient care. We encourage the committee to include certain Medicare proposals, including some that were in the earlier discussion draft, to address concerns with local coverage, coding, and payment of new and breakthrough technologies.
“We look forward to working with members of the committee and their counterparts in the Senate, the administration and other stakeholders to advance this worthy initiative.”
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AdvaMed member companies produce the medical devices, diagnostic products and health information systems that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. AdvaMed members range from the largest to the smallest medical technology innovators and companies. For more information, visit www.advamed.org.