Seven proposed 21st Century Cures Act bills sailed through the Senate HELP Committee last week, including three medical technology-related bills.
The three bills that will have an impact on the device industry are the Medical Electronic Data Technology Enhancement for Consumer’s Health (MEDTECH) Act (S. 1101), the Combination Products Innovation Act of 2015 (S. 1767) and The Advancing Breakthrough Medical Devices for Patients Act of 2015 (S. 1077).
AdvaMed welcomed the efforts, saying they will improve the efficiency of the FDA’s device review process. Specifically, S.1767 would provide greater clarity to the agency’s process for reviewing combination products, ensuring more timely and predictable reviews of these novel products, says JC Scott, AdvaMed’s senior executive vice president for government affairs.
He adds that S.1077 would build on initiatives under way within the FDA to create an accelerated, 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.
Finally, S.1101 would codify FDA’s current regulatory paradigm for medical technologies using software and allow the agency to concentrate its resources on those products that have the greatest potential impact on public health, Scott adds.
The first markup occurred in February, with the committee passing seven bills, including six bills that affect devices and research: the FDA Device Accountability Act of 2015 (S. 1622), the Next Generation Researchers Act (S. 2014), the Enhancing the Stature and Visibility of Medical Rehabilitation Research at NIH Act (S. 800), the Advancing Research for Neurological Diseases Act of 2015 (S. 849), the Preventing Superbugs and Protecting Patients Act (S. 2503) and the Improving Health Information Technology Act (S. 2511) ().
No changes were made to the bills during last week’s markup. A third and final markup is scheduled for April 6 that will then go before a full Senate vote. An agenda has not yet been released. — Michael Cipriano and Jonathon Shacat