The 114th Congress has begun with a burst of activity on funding proposals for the National Institute of Health and other health-related agencies. Here’s a quick look at some of the proposals.
President Obama’s Budget Proposal: Precision Medicine Initiative
President Obama's FY16 budget proposes a new precision medicine initiative with funding for a $215 million investment in the National Institutes of Health (NIH), the Food and Drug Administration (FDA), and the Office of the National Coordinator for Health Information Technology (ONC). The proposal includes:
- $130 million to NIH for development of a national research cohort of 1 million+ volunteers to propel our understanding of health and disease, and to set the foundation for a new way of doing research through engaged participants and data sharing.
- $70 million to the National Cancer Institute to scale up efforts to identify genomic drivers in cancer and apply that knowledge in the development of more effective treatments.
- $10 million to FDA to acquire additional expertise and advance the development of databases to support the regulatory structure needed to advance innovation in precision medicine and protect public health.
- $5 million to ONC to support the development of interoperability standards and requirements that address privacy and ensure the secure exchange of data across systems.
United for Medical Research
United for Medical Research, a coalition of research institutions, patient and health advocates, and private industry, issued a report, Health Funding: Ensuring a Growing and Predictable Budget for the National Institutes of Health, focused on alternative approaches to securing predictable NIH funding. The report offers three suggestions: 1) Adjust spending caps to favor NIH funding increases; 2) Implement multi-year budgeting and appropriations for NIH to increase year-to-year stability and predictability; 3) Examine changes in mandatory programs, trust funds, and dedicated funding streams to increase both funding amounts and stability for biomedical research.
Accelerating Biomedical Research Act (S.318, H.531)
This legislation would allow Congress to restore the purchasing power of NIH’s budget to what it would have been if it had kept up with inflation since 2003. The bill would allow appropriations to increase NIH funding by 10 percent for the first two years and about 6 percent each year thereafter through 2021.
American Cures Act (S.289)
The American Cures Act would provide a steady growth rate in federal appropriations for biomedical research conducted at NIH, the Centers for Disease Control, the Department of Defense Health Program, and the Veterans Medical and Prosthetics Research Program. Each year, the bill would increase funding for each agency and program at a rate of GDP-indexed inflation plus 5 percent.
Minnesota senators Klobuchar and Franken are the original cosponsors of the bill.
The Medical Innovation Act (S.320. H.744)
This legislation would require pharmaceutical companies that break the law and settle with the federal government to reinvest a percentage of their profits into NIH.
Permanent Investment in Health Research Act (H.777)
This bill would make NIH funding mandatory instead of subjecting the agency to the annual discretionary appropriations process.
21st Century Cures
The House Energy and Commerce and the Senate Health, Education, Labor, and Pensions (HELP) Committees released draft documents seeking public comment on plans to accelerate the delivery of drugs and devices to patients.
The House committee released a discussion draft outlining specific legislative proposals arising from the 21st Century Cures initiative, which included five white papers and eight hearings, and a number of roundtable discussions convened in Washington and across the country.
The draft focuses heavily on the FDA, but contains proposals related to NIH, including:
- Establishing a program at NIH to help young emerging scientists.
- Requiring NIH to support projects that pursue innovative approaches to major challenges in biomedical research that are high-risk but have the potential to lead to breakthroughs.
- Establishing a working group composed of NIH and stakeholders to provide recommendations on how to streamline the grant process for researchers.
- Requiring the Secretary of Health and Human Services to develop a plan to carry out a longitudinal study designed to improve the outcomes of patients with chronic disease.
- Streamlining the Institutional Review Board process, particularly for clinical trials conducted at multiple sites.
- Clarifying that peer-reviewed journals, journal reprints, journal supplements, and medical textbooks are excluded from the reporting requirement under the Sunshine Act.
In the Senate, the HELP Committee released a report on the challenges of getting safe treatments, devices, and cures to patients more quickly and effectively, and examining what is working and what is not at FDA and NIH.
The senators are soliciting feedback on their report as they also begin a major initiative in the Senate HELP Committee—including a bipartisan working group and a series of hearings—to examine the time and cost currently involved with the drug and medical device discovery and development process, and how to better align public policies to support medical innovation.