The Food and Drug Administration is asking for $100 million in its Fiscal Year 2019 budget request for a new initiative aimed at better utilizing electronic health record data to help streamline clinical development as well as inform the safe and effective use of medical products.
FDA Commissioner Scott Gottlieb, MD, told a Senate appropriations subcommittee on Tuesday that the funding for the initiative would create the capability to “conduct near-real-time evaluation down to the level of individual electronic health records for at least 10 million individuals from a broad range of healthcare settings.”
Currently, the FDA’s active post-market data monitoring systems—the National Evaluation System for health Technology (NEST) for medical devices and Sentinel system for drugs and biologics—depend largely on the secondary use of claims data.
However, Gottlieb testified that the regulatory agency needs to increase its capacity to leverage real-world evidence for the evaluation of medical products to ensure they are developed as efficiently and quickly as possible.
“We seek to expand our active surveillance systems to enhance our real-time understanding of medical product performance by broadening our use of healthcare data to better take advantage of the data available from electronic health records,” he told the senators. “The 2019 budget includes $100 million to advance the use of real-world experience to inform patient care and provide efficient and potentially lower cost ways to develop clinical data to expedite medical product development.”
According to Gottlieb, using data from EHRs will enable the FDA to broaden the indications for use of approved medical products “eventually conducting more late stage development in the real world, making our pre-market development process more efficient.”
Nonetheless, Gottlieb acknowledged that tapping into EHR data will not be an easy task.
“To accomplish this, several things must happen,” he noted. “First, the data must be high quality and interoperable, meaning that the data can be collected in one system, but used in many different systems to inform patient care. And second, we must enable better integration of clinical care and clinical research.”
Ultimately, Gottlieb made the case that by having a real-time, post-market system that takes advantage of real-world evidence, the agency will have more ways to increase its knowledge about the effectiveness of new medical products, which he concluded are “often safer because they can be designed to address safety issues identified through better surveillance.”
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