With the 21st Century Cures Act now law, two key officials from the National Institutes of Health (NIH) took to the New England Journal of Medicine to outline the game-changing legislation from their purview.
Director Collins (second from the left) attended the Senate’s cloture vote on the 21st Century Cures Act earlier this month with Rep. Tim Murphy (R-PA), Rep. Diana DeGette (D-CO), Friends of Cancer Research co-founder Ellen Sigal, and Chairman Fred Upton (R-MI).
NIH Director Francis Collins, M.D., and Dr. Kathy Hudson, Deputy Director for Science, Outreach, and Policy at the NIH write, “As with any landmark piece of legislation, the complex negotiations leading up to its passage were challenging and intense. But the final provisions are well worth heralding, including increased support for state efforts to combat opioid abuse, new steps aimed at improving mental health services, and important changes affecting the Food and Drug Administration and the National Institutes of Health (NIH).”
Their column walks through provisions in the bill that reduce red tape, increase data sharing while also protecting privacy, and provide support for early-stage researchers.
Drs. Collins and Hudson conclude, “Congress has provided an enormous gift to science in the form of the Cures Act, a gift that reflects a deep confidence in the promise of biomedical research to make discoveries and develop cures in the 21st century. All those who made this gift possible — the President and Vice President, lawmakers, stakeholders, and most of all, patients — deserve our heartfelt thanks.”
To learn more about 21st Century Cures, click here.
December 13, 2016
The 21st Century Cures Act – A View from the NIH
The Cures Act, formally known as H.R. 34 or the 21st Century Cures Act, passed overwhelmingly in the U.S. House of Representatives and Senate in the waning days of the 114th Congress and was signed into law by President Barack Obama on December 13, 2016. Weighing in at nearly 1000 pages, this bipartisan bill is the product of years of hard work by Republican and Democratic lawmakers, in collaboration with a broad array of diverse stakeholders. As with any landmark piece of legislation, the complex negotiations leading up to its passage were challenging and intense. But the final provisions are well worth heralding, including increased support for state efforts to combat opioid abuse, new steps aimed at improving mental health services, and important changes affecting the Food and Drug Administration and the National Institutes of Health (NIH).
Here, we focus on aspects of the Cures Act that are directly relevant to the NIH’s mission — measures that will provide the agency with critical tools and resources to advance biomedical research across the spectrum from basic, curiosity-driven studies to advanced clinical trials of promising new therapies. Affecting everyone from researchers to research participants to patients suffering from numerous conditions, these measures will cut bureaucratic red tape that slows the progress of science, enhance data sharing and privacy protections for research volunteers, improve support for the next generation of biomedical researchers, exhort the NIH to extend its efforts to ensure inclusion of diverse populations, and provide the NIH with a bolus of additional funding over 10 years for key biomedical research initiatives. …
Some key measures reduce red tape. Policies generated with the best intentions sometimes have serious adverse consequences for research. Two needlessly obstructive policies have been undone by the Cures Act — one dealing with paperwork and the other with scientific meetings. …
Other measures in the bill relate to data sharing and privacy protection. Sharing data is essential for progress in biomedical research. Rapid data sharing was key to the success of the Human Genome Project, and that same commitment has been spreading across biomedicine in the past two decades, as advances in technology and “big data” have enabled an entirely new level of data sharing and inquiry. Despite the clear value of sharing data, the NIH has been constrained from requiring in a straightforward way that NIH-funded investigators share their data. The Cures Act solves this problem by allowing the NIH director to require that data from NIH-supported research be shared, giving all scientists the opportunity to use these data as quickly as possible to advance biomedical research.
This new era of rapid and facile exchange of data also requires redoubled efforts to protect the privacy and confidentiality of information about research participants. People who volunteer for research need to be confident that scientists will do everything in their power to protect their private information. The Cures Act contains what we believe are the most significant advances in research privacy protections in two decades. Certificates of confidentiality, previously available to researchers upon request, will now be provided to all NIH-funded scientists conducting research that involves the collection of identifiable, sensitive information. The certificates will provide stronger protections against the disclosure of the names of participants or any other identifiable data gathered during research. In addition, the Cures Act will allow the NIH to withhold biomedical information about individuals that could be used to reidentify them through requests for records filed under the Freedom of Information Act.
Cures Act provisions also support early-stage researchers. Today, the average age of a researcher receiving his or her first independent research grant from the NIH is 42. The NIH has been working hard to create additional opportunities for younger researchers, including dedicated awards for new and early-stage investigators. Though such efforts have proven valuable for encouraging individual researchers, they have not resulted in a lowering of the average age of independent investigators within the full NIH research portfolio. Provisions in the Cures Act will establish an office at the NIH to promote policies aimed at improving coordination and analysis of opportunities for new and early-stage investigators, as well as at attracting, retaining, and developing emerging scientists in priority research areas. …
The Cures Act provides multiyear funding for three highly innovative scientific initiatives launched by the Obama administration: the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative, the Precision Medicine Initiative (PMI), and the Beau Biden Cancer Moonshot. It also includes a promising new research initiative focused on regenerative medicine (see table Funding for NIH Innovative Research Initiatives under the Cures Act.). …
Congress has made it clear that these focused investments are not intended as a substitute or offset for supporting NIH research through the regular appropriations process. Although the decision about the overall fiscal year 2017 funding level for the federal government to support all NIH research across disciplines and disease areas has been postponed until April 2017, the Cures Act funding is available now and will be used right away to support groundbreaking research. We remain optimistic that strong support for the NIH budget will be reflected in the ultimate decisions about the fiscal year 2017 budget and beyond.
In the meantime, Congress has provided an enormous gift to science in the form of the Cures Act, a gift that reflects a deep confidence in the promise of biomedical research to make discoveries and develop cures in the 21st century. All those who made this gift possible — the President and Vice President, lawmakers, stakeholders, and most of all, patients — deserve our heartfelt thanks.
Click HERE to read the entire column online.
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