FDA Foresees Few Patient Safety Issues with Data from Rx Apps

The FDA is suggesting a hands-off approach to reviewing prescription drug applications that present data with low risks to patient safety, the agency said in a request for comments published in the Federal Register. The solicitation for industry opinions is part of the process of establishing a framework for managing the emerging market for digital health tools that can monitor medication adherence, provide data about utilization, or help maintain correct usage of prescription substances. While tools and apps that act as companions for prescription drugs are likely to be valuable assets for drug manufacturers and patients, they are also generally expected to pose little safety risk, the FDA noted. Minimizing barriers to innovation and creating speedy pathways for deployment of data-driven tools may further improve the effectiveness and uptake of these strategies, added the agency.