On Tuesday, April 28th the Senate Health, Education, Labor and Pensions Committee held a full committee hearing on Continuing America’s Leadership: The Future of Medical Innovation for Patients. The focus of the hearing was to hear from leaders from both the National Institute of Health (NIH) as well as the Food and Drug Administration (FDA) on how to accelerate the amount of time it takes for medical innovations to go from “lab to cabinet.” The Senate HELP effort is a companion to the House Energy and Commerce Committee’s 21st Century Cures initiative. Witnesses at Senate HELP Committee hearing also testified before the House Energy and Commerce Committee on Thursday, April 30th.
- Roderic I. Pettigrew, PhD, MD , Director, National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health, Bethesda, MD
- Christopher P. Austin, MD , Director, National Center for Advancing Translational Sciences, National Institutes of Health, Bethesda, MD
- Janet Woodcock, MD , Director, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD
- Jeffrey E. Shuren, MD, JD , Director, Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD
In his opening statement Chairman Lamar Alexander (R-TN) remarked:
Today, medical products take more time and money to discover, develop, and reach the American patients than ever before. We have heard that the FDA has difficulty regulating the most cutting-edge medical products. This disparity between the pace of scientific discovery and FDA’s scientific knowledge is threatening America’s position as a global leader in medical innovation. We read in the paper and hear stories about drugs and devices available to patients outside the U.S. first, such as the heart valve mentioned earlier or a drug for multiple sclerosis. Private investment is shifting away from early-stage drugs and devices in part due to increasing regulatory burden and uncertainty.
In her opening statement Ranking Member Patty Murray (D-WA) remarked:
Over the last half century our medical system has taken huge leaps forward. We’ve moved from a system in which many patients had no idea whether medical products would help them, hurt them, or do nothing at all, to one in which FDA-approved treatments are the global gold standard for safety and effectiveness—a standard that patients and families have come to trust when making decisions about their health.
In his opening statement, Dr. Roderic Pettigrem remarked:
The use of mobile technology has the potential to greatly assist researchers in gaining a better understanding of the environmental and behavioral factors that cause disease with the goal of preventing or intervening in the process. Today, smartphones are natural points of engagement for the large percentage of U.S. adults who own them. Interfacing smartphones with a variety of biosensors may allow the linkage of an individual’s electronic medical records and genomic data with information captured by the smartphone on environmental exposure and behavior if it were done with appropriate security and privacy protections. From measuring secondary smoke exposure to counting steps, or testing vision, smartphones can record, track, and transmit a significant amount of health information. Smartphones can also be used as a tool for healthier living. They can be programmed to send automatic reminders to take a medication or an alert when a dose is missed. The overarching potential application relevant to the Precision Medicine Initiative is to link and enrich the genomics and electronic health record data with a broad range of medical exposure and lifestyle information. This set of “big data” can then be evaluated or “mined” to identify new ways to improve human health
In August, 2014 HIMSS provided a letter to the Senate Finance Committee on Data Availability.