Premier Provides Input on FDA’s Data and Technology Strategic Plan

Premier submitted comments to the Food and Drug Administration (FDA) in response to a request for information (RFI) regarding the development of an FDA Data and Technology Strategic Plan. In these comments, Premier identified technologies and/or methodologies that could support solutions to help drive a more integrated, streamlined environment for industry and better facilitation of data technology to treat disease faster, create more effective practices and achieve better outcomes. Our comments focused on four areas:

• Integration of data technology to address drug shortages: Premier detailed our experience with the public health emergency over the past few years and provided detailed comments regarding the need to create robust, timely and transparent data to predict supply levels, product burn rates and sourcing challenges as well as the ability to pivot distribution response and share this vital information in a timely manner across the supply chain.
• Supply chain visibility: In addition to creating robust and timely data, Premier believes that there are gaps in transparency regarding potential medical device and product shortages. We urged FDA to automate manufacturer data collection and notifications to help address data reliability and quality issues, and thus improve trust in the data.
• Efforts to improve medical device cybersecurity: As the FDA develops this Data and Technology Strategic Plan, Premier believes it is important to call out the need for final guidance related to cybersecurity of medical devices. The use of these devices is growing quickly, and it is vital to clarify security requirements for devices and comparative accountability for various entities.
• Use of real-world evidence to inform regulatory decision making: Premier commented on the increased use of real-world data (RWD) and real-world evidence (RWE) to inform regulatory submissions. Premier believes this data does provide actionable insights that improve research and accelerate the process of bringing new innovations to patients. However, we believe it will be important for the FDA to implement a transparent RWD and RWE screening process and incorporate detailed guidance and protocols regarding selection of appropriate real-world data sources and specific areas and phases of application of RWE/RWD into the strategic plan.