Leaders from the National Institutes of Health (NIH) and Food and Drug Administration (FDA) reported to the House Energy and Commerce Subcommittee on Health at a July 25 hearing on their respective progress toward implementing the 21st Century Cures Act (Cures).
Enacted in December 2016, the Cures Act aims at modernizing the discovery, development and delivery of innovative medical products. The legislative package authorized funding for major NIH research endeavors including the Precision Medicine Initiative (now, the “All of Us” program), the Brain Research Through Advancing Innovative Neurotechnologies (BRAIN) Initiative and the Cancer Moonshot. It also mandated modifications and revisions to various FDA regulatory processes, among numerous reforms.
The hearing was the committee’s second status update on Cures implementation.
NIH Director Francis Collins, MD, PhD, reported that approximately 86,000 volunteers have signed up with the All of Us research program, as it proceeds toward its goal of recruiting one-million volunteers for the study. Stephanie Devaney, PhD, deputy director of the All of Us program, mentioned that a major challenge is receiving data from volunteers seamlessly through electronic health records.
As part of Cures implementation, the NIH is making progress on its Data Commons Pilot. It will help address biomedical research challenges on how to measure the usefulness of data sets, where shared data should be stored, how patient protections are insured, how interoperability is achieved and what tools researchers most need in the shared environment.
Related to the Pilot program, the NIH recently launched the Science and Technology Research Infrastructure for Discovery, Experimentation and Sustainability (STRIDES) Initiative. It involves a partnership between the NIH and commercial cloud service providers to offer biomedical researchers cloud-based access to large data sets and associated computational tools.
In FY 2018, the NIH expects to fund 150 new BRAIN Initiative projects ranging from data infrastructure and sharing to human brain studies including advancing brain imaging. The NIH funded 142 Cancer Moonshot awards in FY 2017 and released 17 Cancer Moonshot-specific funding opportunity announcements in FY 2018.
FDA Commissioner Scott Gottlieb, MD, updated the subcommittee on the agency’s implementation of Cures mandates to revise various regulatory processes related to the safety and effectiveness of drugs, biologics and medical devices. Radiology-related efforts included the FDA’s National Evaluation System for Health Technology (NEST) for real-world performance evaluation — with which the ACR Data Science Institute is involved — and the modernization of the FDA’s approach to digital health products including the agency’s ongoing development of its Software Precertification Program. The American College of Radiology laid out its position on the Software Precertification Program in a May 31, 2018, comment letter.