Over 150 organizations sent an open letter to the leaders of the Senate Health, Labor, Educations and Pensions Committee, supporting them for advancing legislation that will form the basis of the Senate’s version of the 21st Century Cures Act, which passed the House last year.
The Senate committee has passed 19 bills since February—collectively referred to as medical innovations legislation—which include agreements on NIH funding, support for the Precision Medicine Initiative, and changes to FDA and NIH hiring power. Now, the committee has to work to find ways to pay for the programs before sending the bills to the full Senate.
Committee Chairman Lamar Alexander (R-Tenn.) said his goal is to present the legislation to the Senate leadership combined with an NIH Innovation Fund that would provide a surge of one-time funding for priorities such as the vice president’s National Cancer Moonshot Initiative Young Investigator Corps, the Big Biothink Awards and the BRAIN Initiative.
“With its 21st Century Cures Act passed last year, the House voted 344 to 77 to provide $8.8 billion in paid-for mandatory funding to support such NIH priorities,” Alexander said April 6, after the committee approved the final five bills of the medical innovations package with bipartisan support. “We continue to work to find an amount that the House will agree to, the Senate will pass and the president will sign.”
“The legislation would create a breakthrough path for new medical devices like the breakthrough drug path approved in 2012 that has already attracted 384 applications and led to 39 approvals,” he said.
“It would give the FDA new authority to attract talented researchers, and reduce the administrative burden on NIH and researchers. It would target rare diseases, including diseases resistant to antibiotics. It would allow NIH to require researchers who use NIH funds to share their data. It would encourage interoperability of electronic medical records, reduction in excessive physician paperwork, clarify each patient’s right to own their own medical record, and discourage information blocking.”
The next day, during an appropriations subcommittee hearing on the FY2017 budget for NIH, Sen. Patty Murray (D-Wash.) said: “I was very pleased that in the recent budget deal, Democrats and Republicans were able to come together to boost discretionary investments in the NIH. That was an important step forward—but I don’t see any reason to stop there.” Murray is the ranking member on the HELP committee.
“That’s why I’ve made clear, in my discussions with Chairman Alexander about legislation to advance medical innovation in the HELP Committee, that if we really want to get patients safer, more effective treatments and cures, we have to take advantage of every funding opportunity, including mandatory investments in the NIH. It’s a make or break priority.”
On April 6, the Senate HELP committee passed:
• The FDA and NIH Workforce Authorities Modernization Act (S. 2700), which increases the FDA’s ability to hire and retain employees and pay them a salary more competitive with the private sector, and enables the FDA to more fully participate in the Biomedical Research Service to attract scientists.
• The Promise for Antibiotics and Therapeutics for Health Act (S. 185), which helps streamline approval of treatments for antibiotic-resistant bacteria.
• The Advancing Precision Medicine Act of 2016 (S. 2713), supporting the president’s Precision Medicine Initiative and efforts to map one million genomes.
• The Advancing NIH Strategic Planning and Representation in Medical Research Act (S. 2745), which requires NIH to develop a strategic plan every six years, and helps ensure the inclusion of women and minorities in research.
• The Promoting Biomedical Research and Public Health for Patients Act (S. 2742), which requires the NIH to cut inconsistent or duplicative reporting requirements for researchers, and also allows those performing clinical research supported by the National Center for Advancing Translational Sciences to conduct later-stage clinical trials.
“The Innovations effort encompasses a surge in funding for the National Institutes of Health,” the 150 organizations wrote in their open letter to the HELP committee and Senate leadership April 27.
“The groundbreaking research NIH fosters, coupled with private sector investment and innovation, fuels our economy, grows jobs and most importantly saves lives. By putting more muscle behind NIH at a time of unprecedented opportunity for breakthrough progress, the Innovations initiative can—and will—shift the fight against deadly and debilitating diseases into high gear.”
Led by Research!America, other organizations signing the letter include the American Heart Association, the American Lung Association, and the Association of American Cancer Institutes, as well as several universities, health systems, cancer research centers, and professional societies. The full letter and list of organizations is available here.