FDA Launches App to Report Fresh Uses for Existing Drugs

A new mobile app launched globally by the Food and Drug Administration Thursday empowers health care providers to access and report fresh uses of existing medicines and medical devices for patients with difficult-to-treat infectious diseases through a one-stop internet-based repository. 

“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,” FDA’s Principal Deputy Commissioner Dr. Amy Abernethy said. “When health care 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.”

According to the FDA, clinical professionals are permitted to prescribe legally marketed human drugs or medical devices for uncleared uses when they deem it medically appropriate for an individual patient. Created through a collaboration between the agency and the National Institute of Health’s National Center for Advancing Translational Sciences, the app harnesses crowdsourcing to leverage new medical observations around the outcomes that occur when certain drugs are used in new populations, doses and combinations or for new indications. 

Health care professionals can access the app to share information about all that’s encountered when approved medical products are used for unapproved cases, and they can also browse across already-documented instances. Users can also interact with other clinicians from across the globe and engage with others on a treatment discussion forum.

“The systematic collection of real-world experience in the app will help identify drug candidates for additional study, encourage further drug development, and may serve as a resource for practitioners making individual patient treatment decisions in the absence of established safe and effective options,” officials said. “The FDA plans to reach out to health care providers in various disciplines, including infectious and tropical diseases, to encourage them to use the app.”

Several pilot versions of CURE ID were launched ahead of this official release and users from the U.S., Europe, Peru, India and South Africa shared their own feedback as it was developed. The newly-released version includes a newsfeed and a search feature with data from 325 different infectious diseases and syndromes. It also already encompasses nearly 1,500 initial cases and over 18,000 clinical trials.

“Our hope is that this app will serve as a connector among major treatment centers, academics, private practitioners, government facilities and other health care professionals from around the world and ultimately get treatments to patients faster,” Abernethy said.