New Draft of 21st Century Cures Legislation Now Available

Lawmakers in the U.S. House of Representatives released a new “discussion draft” on April 29 of the “21st Century Cures” legislation. The proposal would make legislative changes to the medical device and drug development and delivery process.

The legislation originally was introduced last year by Reps. Fred Upton (R-Mich.) and Diana DeGette (D-Colo.). During the recent annual meeting of the Florida Medical Manufacturers Consortium (held May 4-5) in St. Petersburg, Fla., Rep. Gus Bilirakis (R-Fla.) told attendees that the House should vote on the legislation by “late May, early June” and that the Senate currently was working on its own version.

The House Energy & Commerce Committee’s new draft of the bill would ramp up funding for the National Institutes of Health (NIH) to $31.8 billion in fiscal 2016 and to $34.85 billion in 2018. Congress appropriated $30.3 billion for the NIH in fiscal 2015, and the White House requested $31.3 billion for fiscal 2016. The bill creates an NIH Innovation Fund of roughly $2 billion per year between 2016 and 2020 to support precision medicine, young emerging scientists and other unidentified sources of medical innovation.

The bill also would revise U.S. Food and Drug Administration (FDA) oversight of the drug and medical device sectors. Consumer watchdog group Public Citizen hasn’t been as enthusiastic about the prospects as medical device and pharmaceutical industry representatives. The legislation would provide “perks to the pharmaceutical and medical device industries to approve medications and devices faster based on weaker evidence,” the group said.

The bill would create a “breakthrough device” program to provide a faster path to market for devices that might raise the standard of care. It would expand the FDA’s humanitarian device exemption for products that treat rare diseases. Under current regulations, a device treating a disease affecting fewer than 4,000 patients annually receives less regulatory scrutiny. The provisional section would raise the threshold to 8,000 patients.

FDA officials have testified on Capitol Hill that the agency already is overburdened and underfunded, which compromises reviewers’ ability to efficiently evaluate drugs and devices. Despite protestations, the proposed legislation calls on the agency issue new guidance and more public meetings. What the bill doesn’t do is specifically request any more FDA funding.

Margaret Hamburg, M.D., who stepped down as FDA commissioner in late March, told Modern Healthcare that the bill’s
approach is off the mark.

“Shortening review times is not going to create the scientific understanding and the research and development that needs to be done to translate exciting opportunities in science into new products,” she said in a recent interview. “That is the wrong mechanism to achieve that goal.”

Medical device industry groups were more optimistic.

“AdvaMed commends Chairman Fred Upton and Reps. Diana DeGette, Frank Pallone (D-N.J.), Joe Pitts (R-Pa.), and Gene Green (D-Texas) for their leadership on exploring ways to accelerate the discovery, development and delivery of new treatments and cures in the U.S. This is an issue that affects every American family, and the strong bipartisan support for moving forward is heartening,” said Stephen J. Ubl, president and CEO of the Advanced Medical Technology Association (AdvaMed). “While we are still reviewing the details of the committee’s revised discussion draft, we are pleased it includes a number of proposals to improve the innovation ecosystem that supports the development of life-saving, life-enhancing medical technology.

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,” according to AdvaMed’s chief executive.

“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,” Ubl added. “While these proposals are important, we encourage the committee also to consider additional reforms that address Medicare coverage and payment challenges that restrict access to new technologies that improve patient care.  We encourage the committee to include certain Medicare proposals, including some that were in the earlier discussion draft, to address concerns with local coverage, coding, and payment of new and breakthrough technologies.”
Sara Radcliffe, president and CEO of the California Healthcare Institute (CHI), a non-profit organization representing more than 275 life-sciences organizations, also lauded the proposed legislation and its “thoughtful” and “bipartisan” approach to “spurring scientific discovery that will provide hope for patients and their families while also protecting jobs and America’s leadership role in healthcare innovation.”

“The 21st Century Cures draft legislation represents a critical step forward for ensuring that California and the nation remain the leader in worldwide life-sciences innovation,” Radcliffe said. “We applaud the inclusion of meaningful funding increases and reforms that will bolster federal research efforts at the National Institutes of Health, and important proposals to modernize regulatory and payment mechanisms to ensure enhanced development of and access to needed medicines and technologies for the future. As life-sciences innovators, we look forward to continuing our work with Chairman Upton, Congresswoman DeGette, bipartisan members of the committee, House [of Representatives] leadership, and our congressional delegation to advance this proposal into transformative legislation that will propel biomedical innovation and benefit patients in the U.S. and around the world for many years to come.”