The U.S. House Energy and Commerce Committee’s health subcommittee held a hearing this week to receive updates on the implementation of the 21st Century Cures. Francis S. Collins, director of the National Institutes of Health, and Scott Gottlieb, commissioner of the Food and Drug Administration, provided testimony and updates from their agencies.
Highlights from the hearing are below. You can watch a recording here. We’re including timestamps on our highlights for your quick reference.
17:17 – U.S. Rep. Michael Burgess, R-Texas, chairman of the subcommittee, opened the hearing touting the importance on the year-old legislation’s impact on the landscape of the nation’s public health. “While the United States has maintained its global leadership in biomedical innovation, there existed a potential bridge in the growing divide between the revolutionary advances in science and technology and a less-than-adequate system for discovering, developing and delivering new therapies,” said Burgess. The 21st Century Cures Act authorized the NIH to provide additional support for biomedical research and reduce administrative burdens. The legislation included support for the Precision Medicine Initiative, the BRAIN initiative, and the Cancer “moonshot” to accelerate research at the NIH and move discoveries made at the agency closer to treatments and cures for diseases.
22:51 – U.S. Rep. Gene Green, D-Texas, remarked on the bipartisan nature of the legislation at a time when Congress was in a political deadlock. “The 21st Century Cures demonstrates what we can accomplish when work across the aisle, and I hope we can do so again,” said Green.
45:17 – Collins said he appreciates that the Cures Act aims to reduce administrative burdens and expand the NIH’s ability to make additional awards for cutting-edge research. He focused on innovations that resulted from the legislation. The agency funded 110 new BRAIN initiative research projects. NIH joined with the FDA and 12 pharmaceutical companies to launch a partnership for identifying biomarkers for the development of cancer immunotherapies. NIH also launched the Regenerative Medicine Innovation Project, which has issued eight awards covering a broad swath of research on diseases like diabetes and sickle cell disease. The Precision Medicine Initiative’s All of Us Research program will enroll more than 1 million Americans with the goal of creating a research resource that will help investigators better address the health concerns of specific demographics.
55:42 – U.S. Rep. Greg Walden, R-Oregon, chairman of the House Energy and Commerce Committee, asked Collins how the NIH is addressing the biomedical research workforce’s bias towards late-career investigators. The Cures Act required that the NIH develop strategies to better support the next generation of researchers. Collins highlighted the new Next Generation Research Initiative. According to Collins, the agency is working to recapture new investigators who have submitted their first NIH proposals in fiscal year 2017 but have missed the funding cutoff. The agency is also seeking to identify those investigators who are at risk of having funding gaps and have missed the opportunity to receive a renewal as a demographic needing some support to keep their labs open. Collins remarked that funding for those investigators likely will come from reallocating funds — by either not continuing to be “quite as generous” in some areas of research or not providing awards for labs that are “extremely well-funded.” Collins said: “If our mission is to try to find every place that we can to use the dollars that the Congress provides us to get the maximum benefit, those young investigators getting started are a critical part of that.”
58:41 – Green asked how the NIH is encouraging students to pursue education that will lead to careers in research on antibiotic discovery and development. Collins said the agency’s efforts to support the next generation of researchers would have the “lifting all boats” effect on the infectious disease research workforce. Gottlieb added that the FDA will be taking steps to reduce the use of antibiotics in livestock and accelerate the rollout of products targeted at antibiotic-resistant organisms.
1:10:09 – U.S. Rep. Frank Pallone, D-N.J., addressed the potential effects of the current U.S. House tax bill on graduate education. Of particular interest to Pallone was the effect of making tuition waivers taxable and how that might affect the biomedical research enterprise. Collins said any impediment to graduate students would negatively affect the enterprise. 2:07:55 – U.S. Rep. Tony Cardenas, D-Calif., questioned the impact of personnel vacancies at the two agencies. He wondered if Congress should help facilitate the filling of these vacancies to increase the productivity of the agencies. Both Collins and Gottlieb focused their comments on activities being conducted at their respective agencies to further the efficiency of internal operations by streamlining the administrative process. Collins also pointed out that around 80 percent of NIH’s funds go toward extramural research and that he and his principal director, Larry Taybak, are deliberate about making personnel selections.
2:09:38 – Cardenas continued his line of questioning by asking if the federal government should continue to help people become scientists and doctors. “If Congress actually took away some of the little things that help them get their education,” he asked, “would that be a good thing or a bad thing?”
The remainder of the hearing covered research discoveries and increased agency support to better facilitate manufacturing in the biotech industry. Members of the committee continuously stated their pride in the 21st Century Cures Act and expressed gratitude to both Collins and Gottlieb for their service to the nation’s health.
Read Collins’ full written statement here.
Read Gottlieb’s full written statement here.