News Feature | May 1, 2015

21st Century Cures Bill Proposes Breakthrough Medical Device Program, Expanded HDEs

By Jof Enriquez,
Follow me on Twitter @jofenriq


U.S. legislators recently released a discussion draft of the medical innovation bill known as the 21st Century Cures Initiative. The legislation aims to hasten the discovery, development, and delivery of new medical devices and drugs, particularly for the treatment of thousands of diseases for which there are no cures.

The proposals in the draft include ways to revamp how agencies such as the National Institutes of Health (NIH) and the Food and Drug Administration (FDA) foster and regulate medical innovation in the U.S.

“Health research is moving quickly, but the federal drug and device approval apparatus is in many ways the relic of another era. We have dedicated scientists and bold leaders at agencies like the NIH and the FDA, but when our laws don’t keep pace with innovation, we all lose,” read a statement from the office of Energy and Commerce Committee Chairman Rep. Fred Upton (R-Mich.), who leads the initiative with Rep. Diana DeGette (D-Colo).

The discussion draft proposes a priority review program for breakthrough medical devices for which no approved alternatives exist, or which offers significant advantages to existing alternatives. The availability of these “breakthrough devices” must be established to be in the best interest of patients. The FDA will judge breakthrough designation, and if approved, will conduct a priority review to expedite the approval of a device.

The draft also seeks to raise the limit for humanitarian device exemption (HDE) applications. Currently, HDEs are granted for rare diseases affecting fewer than 4,000 people, but the legislation will increase it to not more than 8,000, which will allow more patients to receive care using the latest device technologies.

Another proposal is to utilize non-local institutional review boards for review of investigational device exemptions (IDEs) and HDEs.

The draft legislation also calls for an increase of NIH funding to $32 billion for fiscal year 2016, $33.3 billion for 2017, and nearly to $35 billion for 2018. A $2 billion annual NIH Innovation Fund through 2020 is also proposed to support precision medicine, young emerging scientists, and other unspecified areas of medical innovation, BioWorld reports.

Other provisions include modernizing clinical trials, supporting personalized medicine, fostering the development of biomarkers, and utilizing patient perspective on the development process.

The Medical Device Manufacturers Association (MDMA) recently praised the release of the discussion draft of the 21st Century Cures bill.

“MDMA looks forward to reviewing the latest draft which includes the input of countless stakeholders, and represents a comprehensive attempt to accelerate getting American innovation into the hands of America’s patients and providers,” Mark Leahey, president and CEO, MDMA, said in a statement. “MDMA thanks Chairman Upton and Congresswoman DeGette for their leadership on this important work and we will continue to help them advance the common goals of improving patient care and innovation.”  

The Advanced Medical Technology Association (AdvaMed) also lauded the inclusion in the draft of relevant proposals meant to streamline regulatory approvals.

“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,” Stephen J. Ubl, president and CEO, AdvaMed, said in a statement.

“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,” he added.

According to Healthcare IT News, the committee in the past several months has held eight hearings, issued several white papers, and hosted more than two-dozen roundtables across the country to gather ideas for the 21st Century Cures initiative. Patients and providers, as well as representatives from the medical device, pharmaceutical, information technology, legislative, and government sectors were consulted. The Subcommittee on Health will hold a hearing this week to review the draft legislation.

A similar bill is being advanced in the Senate by Sens. Richard Burr (R-N.C.), Michael Bennet (D-Colo.), and Orrin Hatch (R-Utah). The Advancing Breakthrough Devices for Patients Act (ABDP Act) also calls for an expedited approval pathway for breakthrough medical devices.