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Second Opinion

Learn about policy issues important to medical schools and teaching hospitals, with Executive Vice President Atul Grover, M.D., Ph.D.

Washington Highlights

House Panel Advances 21st Century Cures Bill

May 15, 2015—The House Energy and Commerce Subcommittee on Health May 14 approved the 21st Century Cures Act by unanimous voice vote. The subcommittee approved a bipartisan amendment in the nature of a substitute released the day before the mark-up by full committee chair Fred Upton (R-Mich.), Oversight and Investigation Subcommittee ranking member Diana DeGette (D-Colo.), full committee ranking member Frank Pallone (D-N.J.) , Health Subcommittee chair Joe Pitts (R-Pa.), and Health Subcommittee ranking member Gene Green (D-Texas).

In opening statements, subcommittee members generally praised the bill and the bipartisan effort behind it, but cautioned it is still very much a work in progress.

Chairman Pitts called the bill “the culmination of a concerted effort and hard work,” but added, “There is much in this bill to be proud of and enthusiastic about and even optimistic for, but I also realize we still have more work to do and improvements to make.” Chairman Upton added, “This subcommittee mark-up is just the first step. We have a number of steps to go.”

Rep. Joe Barton (R-Texas), who chaired the Energy and Commerce panel when it last reauthorized the National Institutes of Health (NIH), noted the agency spends $6 billion on indirect costs and urged inclusion of language “to begin to reign in or reduce these costs.”

The 21st Century Cures Act would reauthorize the NIH for three years at the following levels:

  • FY 2016 - $31.811 billion;
  • FY 2017 - $33.331 billion; and
  • FY 2018 - $34.851 billion.

The bill also authorizes a five-year, $10 billion NIH Innovation Fund, with $2 billion per year in mandatory appropriations routed through the NIH Director. The bill allocates the Innovation Fund for various purposes, including a new Accelerating Advancement Program, research awards tied to a specific project or objectives, research awards for innovative scientists and early stage investigators, high-risk high reward research, research awards to small businesses, and the NIH intramural program.

At least $500 million from the Innovation Fund must be allocated to the new Accelerating Advancement Program, which would provide matching funds to NIH institutes and centers to fund innovative research projects that could not be funded within the institute/center’s current budget in areas including in biomarkers, precision medicine, infectious diseases, and antibiotics.

Among other research related provisions, the bill:

  • Requires NIH to issue a strategic plan;
  • Establishes a Biomedical Research Working Group to provide recommendations on how to streamline the grant process for researchers;
  • Exempts certain NIH research activities from the Paperwork Reduction Act;
  • Includes a “sense of Congress to reiterate the importance of scientific conferences and meetings to the mission of NIH”;
  • Requires NIH to issue guidelines regarding the inclusion and exclusion of children and the elderly in clinical trials;
  • Provides the National Center for Advancing Translational Science (NCATS) with more flexibility on the use of Other Transaction Authority (OTA) so it can operate like the Defense Advanced Research Projects Agency (DARPA);
  • Requires each NIH institute, as appropriate, to conduct or support high risk, high reward research;
  • Improves loan repayment programs for NIH researchers;
  • Creates a “capstone grant” program to support outstanding scientists who have been funded by NIH at the end of the careers;
  • Requires NIH to establish a national pediatric research network;
  • Requires NIH to post clinical trial inclusion and exclusion criteria in a standardized format; and
  • Mandates a seven-year pilot project of a data sharing system for data from clinical trials solely funded by NIH.

Chairman Pitts called the bill “the culmination of a concerted effort and hard work,” but added, “There is much in this bill to be proud of and enthusiastic about and even optimistic for, but I also realize we still have more work to do and improvements to make.” Chairman Upton added, “This subcommittee mark-up is just the first step. We have a number of steps to go.”

The full Energy and Commerce Committee is tentatively scheduled to consider the bill the week of May 18.

Contact:

Dave Moore
Senior Director, Government Relations
Telephone: 202-828-0559
Email: dbmoore@aamc.org

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For More Information

Jason Kleinman
Sr. Legislative Analyst, Govt. Relations
Telephone: 202-903-0806
Email: jkleinman@aamc.org