FDA, NIH Emphasize Importance of Data in Medical Innovation Efforts
March 13, 2015 in News
At a Senate committee hearing this week, officials at FDA and NIH addressed current efforts to advance medical innovation, emphasizing the importance of health care data, Clinical Innovation Technology reports.
At the Senate Health, Education, Labor and Pensions Committee’s hearing on Tuesday, Chair Lamar Alexander (R-Tenn.) said that the process of developing drugs is slow and costly and called on stakeholders to make improvements.
During the hearing, NIH Director Francis Collins said the agency is planning to launch an initiative involving at least one million volunteers that aims to improve chronic disease prevention.
He said, “This venture will pioneer a new model for doing science that emphasizes engaged participants, technologically advanced collection of many different data types, responsible data sharing and privacy protection.”
Meanwhile, FDA Commissioner Margaret Hamburg said the agency has approved 51 drugs and biologics in the last year — the most in nearly two decades — noting that review times are “consistently faster than other … regulatory agencies” (Walsh, Clinical Innovation Technology, 3//11).
Hamburg also discussed the agency’s Sentinel program, noting its large use of health care data (Slabodkin, Health Data Management, 3/12). In late December 2014, FDA announced plans to expand the five-year pilot program — which uses electronic health records and claims data to monitor the safety of medical products regulated by the agency — and launch a full-scale rollout (iHealthBeat, 1/5).
Hamburg said, “Real-world data provides a vital tool to monitor medical products in use in the marketplace.” She added that while the “science of using big data to establish product effectiveness is still in its infancy,” the use of “appropriate privacy protections” and “leveraging large databases containing patient EHR, disease registry and claims data” has:
- Advanced understanding of health and disease;
- Provided “insights into potential relationships between health-related factors and outcomes”; and
- Provided valuable product safety data (Health Data Management, 3/12).