You are here

Mark Brager
January 20, 2016

AdvaMed Commends Progress on Senate HELP Healthier Americans Initiative

WASHINGTON, D.C. – JC Scott, senior executive vice president of government affairs for the Advanced Medical Technology Association (AdvaMed), issued the following statement today on the Senate HELP Committee’s Healthier Americans initiative:

“AdvaMed commends the Senate HELP Committee for moving forward with its Healthier Americans initiative, which aims to ensure patients have timely access to the latest treatments and cures while helping preserve U.S. leadership in medical innovation.

“The medical technology industry strongly supports the HELP Committee's efforts to take a comprehensive approach to speeding the development and delivery of new medical advancements in the U.S, and we thank Chairman Lamar Alexander (R-Tenn.) and Ranking Member Patty Murray (D-Wash.) for their leadership and commitment on this issue.

“We are pleased that the mark-up schedule includes several pieces of legislation designed to improve the efficiency of FDA's medical technology review process and eliminate redundant regulatory obstacles, including provisions to:  expedite FDA approval of breakthrough medical technologies; improve the agency's review process for combination products; require FDA to take steps so that medical technology reviews are done in the most efficient and expeditious manner possible; allow device clinical trial sponsors to use a central Institutional Review Board to facilitate the conduct of multi-center trials; and improve the CLIA-waiver process to accelerate the availability of point-of-care, rapid diagnostic information to physicians and patients, among others.

“We urge the HELP Committee to continue their forward progress on this important legislative initiative and look forward to working with members, the administration and other stakeholders as the process continues.”