AdvaMed Commends Senate HELP Mark Up of Legislation to Improve Patient Access to Medical Technology

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March 9, 2016 

WASHINGTON, D.C. – JC Scott, senior executive vice president, government affairs, for the Advanced Medical Technology Association (AdvaMed), issued the following statement on today's mark up in the Senate HELP Committee:

"AdvaMed commends the Senate HELP Committee for advancing three medical technology-related bills that will help ensure more timely patient access to the latest medical innovations and improve the efficiency of FDA's device review process.

"The Advancing Breakthrough Devices for Patients Act (S.1077) builds on initiatives already underway within FDA to help create an accelerated and more predictable pathway for breakthrough medical technologies – those that offer the best hope for patients with life-threatening or irreversibly debilitating diseases or conditions who have no or limited alternative treatment options. Today's action shows that the HELP Committee recognizes the vital importance of giving patients access to truly breakthrough medical treatments.

"The Combination Product Regulatory Fairness Act (S.1767) will provide needed clarity to the agency's process for reviewing combination products – whether device/drug, device/biologic or drug/biologic – ensuring more timely and predictable reviews of these novel products and again improving patient access in the long run.

"Finally, the Medical Electronic Data Technology Enhancement for Consumers' Health Act (MEDTECH) (S.1101) will codify FDA's current regulatory paradigm for medical technologies that utilize software and allow the agency to concentrate its resources on medical devices containing software that have the greatest potential impact on public health.

"Taken together, these three bills will help improve patient access to some of the latest medical advancements and foster a more efficient, predictable and transparent review process within FDA, all the while maintaining the agency's strong standards for safety and effectiveness.

"AdvaMed thanks Senate HELP Committee Chair Lamar Alexander (R-Tenn.) and Ranking Member Patty Murray (D-Wash.) and the bills' sponsors for their leadership in moving these important pieces of legislation forward."