SummaryA new FDA resource is available to identify drug candidates for additional study and serve as a resource to shape medical decisions.
Need to Know
On December 5, the FDA launched a global platform for the internet-based app CURE ID. This app allows the clinical community to collaborate and submit infectious and tropical disease case reports with novel uses of existing FDA-approved drugs. The platform is geared towards healthcare providers and is free of use. It was developed by the FDA and the National Center for Advancing Translational Sciences, which is part of the National Institutes of Health (NIH). By creating a repository of data on off-label use of drugs, collected from around the globe, FDA and the NIH may be better poised to identify drug candidates for additional study while also creating a readily available and consolidated resource for physicians tackling challenging disease presentations that lack standard therapy or are entirely treatment-resistant.
Amy Abernethy, FDA principal deputy, said, “The CURE ID application focuses on drugs for infectious diseases lacking adequate treatments, including neglected tropical diseases, emerging infectious threats, and infections caused by antimicrobial-resistant organisms. When healthcare professionals directly input their clinical cases into the app, CURE ID allows these real-world experiences to be organized and analyzed much faster, making it easier to spot promising new uses for existing drugs.”
FDA Gets Involved in Off-Label Drug Use
FDA analyzes data to determine what types of indications are appropriate for a drugs’ label and is also involved in regulating the promotion of medications according to the final agreed upon label. Yet, off label use of approved drugs is within the authority of medical practices and state boards, rather than FDA regulations. Repurposing an already approved drug for new clinical indications can potentially offer an efficient drug-development pathway for treatments of diseases and conditions that have few or no therapeutic options.
New diseases and pathogens are emerging at an unprecedented rate, often with the ability to cross borders rapidly and spread. Global public health security depends on international cooperation and the willingness of all countries to act effectively in tackling new and emerging threats. The FDA monitors diseases from around the world and is dedicated to supporting measures to help better understand those cases that are otherwise challenging. This app is well poised to serve as a vital resource for complicated cases both domestically as well as worldwide.
As the FDA develops this platform and database to connect the world to better understand how diseases are treated, questions remain on how to ensure participation from healthcare professionals. To ensure successful uptake of the platform, users will need to populate the dashboard and participate in the discussion boards. Additional questions exist regarding how far the agency will be willing to extend its activities within the realm of off-label use of approved products.
To download and use the CURE ID application, visit https://cure.ncats.io or download CURE ID from the App or Play Store.
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