The Food and Drug Administration plans to use a proposed $400 million boost in federal funding to focus on a range of innovative approaches to speed the approval of new medical devices and create a new center that would support digital health oversight and address cybersecurity concerns.
Overall, the FDA would receive an additional $473 million in discretionary spending under a budget proposal released by the Trump administration earlier this week, bringing the agency’s total to $3.25 billion in 2019. If that level of spending moves through Congress, the FDA plans to funnel about $400 million to promote innovation and competition, FDA Commissioner Scott Gottlieb, M.D., announced on Wednesday. That would include specific carve-outs planned for a new Center of Excellence on Digital Health and furthering the agency’s ability to use EHR data to evaluate medical devices.
The Center for Excellence on Digital Health would oversee a revamped regulatory paradigm created through the FDA’s new software precertification program launched with nine companies in September. But the center would also create a cybersecurity unit to “enhance its ability to coordinate device-specific responses to cybersecurity vulnerabilities and incidents.” Over the past several years, medical device cybersecurity has emerged as particular concern for industry and regulators.
My statement: FY19 budget req funds #FDA’s current programs at consistent levels/support core public health mission. It also includes addtl ~$400M to advance initiatives to further promote innovation/competition & advance health/safety of American families https://t.co/1YU9m73VoZ— Scott Gottlieb, M.D. (@SGottliebFDA) February 14, 2018
Gottlieb also highlighted an expanded effort to integrate real world data into pre-market and post-market reviews of drugs and medical devices. The additional funding would allow FDA to develop analytic tools and pull real-time data out of EHRs associated with at least 10 million individuals across a range of healthcare settings.
“Toward these ends, an expanded use of natural language processing for the assessment of information submitted to the agency would be developed in an effort to markedly speed recognition and remediation of emerging safety concerns,” he said. “The effort would cover a broad range of medical products, including drugs, biologics and medical devices.”
The use of real-world data has been an ongoing emphasis for the agency, which released new guidelines last year outlining the value and limitations of the approach. In a perspective published in the New England Journal of Medicine (NEJM) on Wednesday, researchers with Tufts University School of Medicine and Vanderbilt Medical Center said the FDA’s use of real-world evidence offers “tremendous opportunities for early identification of safety signals” for medical devices. But they also highlighted concerns that clinical data is imperfect and urged the FDA to adopt a “cautious approach” to using real-world evidence to support device approvals.