March 14, 2016

Legislation Proposing Medical Device Priority Review Moves to Full Senate

March 9, 2016—Senators Orrin Hatch (R-Utah), Michael Bennet (D-Colorado), and Richard Burr (R-North Carolina) announced that the US Senate’s Health, Education, Labor, and Pensions Committee has sent the bipartisan Advancing Breakthrough Devices for Patients Act to the full Senate. The proposed law, which the three Senators cosponsored, seeks to accelerate the approval process for new medical devices so patients have greater access to the care they need.

According to the Senators, the Advancing Breakthrough Devices for Patients Act builds on the Advancing Breakthrough Therapies for Patients Act—another bill sponsored by Senators Hatch, Bennet, and Burr that the Senate passed in 2012. Both the 2012 legislation and this bill share similar principles, including the “all-hands-on-deck” approach to devices. But this bill also expedites the development and review of breakthrough products by enhancing existing tools to approve medical devices, such as priority review.

The text of the bill, S.1077, is available online here. A summary of the legislation is available on Senator Burr’s website, here.

The summary advises, “This bipartisan legislation amends the Food, Drug, and Cosmetic Act to require US Food and Drug Administration (FDA), at the request of a device sponsor, to expedite the development of and provide for priority review of devices that represent breakthrough technologies, for which no approved alternatives exist, offer significant advantages over existing approved or cleared alternatives, or the availability of which is in the best interest of patients.”

In the announcement, Senator Hatch stated, “This measure ensures that FDA can help Americans benefit from the latest life-saving research and innovative devices developed by the medical community. By providing a clear path by which innovators can get breakthrough devices to patients in as timely a manner as possible, we’re giving more patients a fighting chance to improve their lives.”

Senator Bennet commented, “This bill will help spur innovation and ensure these potentially lifesaving and life-changing breakthrough medical devices are safe and available to the patients that need them. 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.”

Senator Burr added, “This bill will help patients get the lifesaving medical devices they need faster. Several years ago, I worked on legislation that expedited the approval process for innovative new drugs that patients need. We know that this process works. The bill that passed out of committee today takes the lessons we learned and applies them to medical devices. Bottom line—this legislation is in the best interest of patients.” 


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