House Energy & Commerce Health Subcommittee Marks Up 21st Century Cures Legislation; Bill Authorizing NIH Funding Increases Goes to Full Committee

Legislative Updates

House Energy & Commerce Health Subcommittee Marks Up 21st Century Cures Legislation; Bill Authorizing NIH Funding Increases Goes to Full Committee

Legislative Update
May 14, 2015

Update:
On Thursday May 21, the full House Energy and Commerce Committee approved the 21st Century Cures legislation, now numbered H.R. 6, by a unanimous vote of 51-0, sending the bill to the House floor. A number of amendments to the bill were offered but then withdrawn by the sponsors, keeping the bill as introduced.

Before the legislation was considered, the bill's sponsors finally added language required under House rules spelling out in detail how to pay for the bill's $13 billion in new funding for the NIH and Food and Drug Administration (FDA). One of the major pay-fors would allow an offset that would cost Medicare Part D drug plans an estimated $5 - $7 billion. The other major pay-for would come from tapping the Strategic Petroleum Reserve (which is under the Committee's jurisdiction and therefore allowed) for $5.2 billion. Both provisions face potential resistance from interested parties.

Chairman Fred Upton (R-MI) has said his goal is to have the bill approved by the House before the July 4 recess. NAEVR has issued a statement commending the Committee/Subcommittee leadership, stating that this action is an encouraging sign for biomedical research funding-although final action on funding is the responsibility of Congressional appropriators.

The Senate Republican leadership has indicated it will act on its own legislation on its own schedule. The Senate Health, Education, Labor, and Pensions Committee has been working on legislation in consultation with the House E&C Committee, and each has also been communicating with their respective chamber's Appropriations leaders.

Initial Posting:

Today the Health Subcommittee of the House Energy & Commerce Committee (E&C) marked up a draft version of the 21st Century Cures Act, sending the bill to the full Committee, which is expected to take up the legislation next week. The Subcommittee passed the bill by voice vote after adopting an amendment in the nature of a substitute to an earlier version of the bill that had been released two weeks ago.

At the markup, a number of Subcommittee members, as well as full Committee Chair Fred Upton (R-MI)-who along with Cong. Diane DeGette (D-CO) are the main sponsors of the initiative-spoke about the importance of the legislation's inclusion of significant new funding for the National Institutes of Health (NIH) in helping advance the main goal of the bill, which is to increase the pace of new scientific discoveries and development of new medical therapies and devices to prevent, treat, and cure diseases and conditions.

The legislation would authorize NIH funding increases of $1.5 billion per-Fiscal Year (FY) for the next three years as follows:

FY2016: $31.8 billion
FY2017: $33.3 billion
FY2018: $34.8 billion

The bill also establishes a new NIH Innovation Fund at $2 billion per-year for the next five years for a total of $10 billion for basic, translational and clinical research. In very specific language, the bill describes how the fund should be used for early-stage investigators, high-risk, high-reward research, and priority disease areas as defined by a required NIH Strategic Plan-although the bill's language mentions examples such as biomarkers, Precision Medicine, and Infectious Diseases.

Committee/Subcommittee leadership comments included:

Chairman Upton highlighted some of the medical advances that have resulted from federal support for medical research and the challenges that remain. He spoke about the high costs, both financial and in efforts to develop new therapies, and how the legislation will start a new chapter in addressing these challenges.

Full Committee Ranking Member Cong. Frank Pallone (D-NJ) said that the increased funding for NIH is central to the effort to the development and delivery of new treatments.

Cong. DeGette, emphasizing the bill's themes of discovery, development and delivery, added that the goal of the legislation is to move new therapies more quickly from the research lab to the clinic. She also mentioned other important sections of the bill, including the increased investment in medical research at the NIH, how it will modernize clinical trials, and its advancement of Precision Medicine.

Cong. Gene Green (D-TX), the Subcommittee's Ranking Member, said that he was pleased with the new funding, calling NIH research essential to improving the nation's health and maintain the United States role as the world leader in medical research.

The E&C Committee has worked closely with stakeholders throughout this process, posting news releases and updates on its Web page that have tracked the legislation and the community's response.