FDA Proposes Simple Pathway for Drug-related Digital Tech
FDA is seeking input on how it can promote the development of digital technologies that would guide safe and effective prescription drug use to help patients improve their health. “As part of this process, we’re seeking input from the public on new steps to modernize our approach to overseeing software products that are designed to be used in conjunction with prescription drugs,” commissioner Scott Gottlieb says in a release. “Consider, for example, a sensor that collects data to track a drug as it moves through the body after being ingested to promote compliance or monitor how a drug is working. Or consider these other examples: A digital health tool that can help collect post market data that can be used to inform the real world performance of a medicine; software that can help patients track symptoms to inform their discussions with providers; an app that helps patients be more aware of a drug’s treatment effects; or one that promotes the proper use of a product or promotes adherence to recommended dosing. The new approach that we’re releasing for comment today would consider the circumstances when software disseminated by drug sponsors to be used with a prescription drug would require approval by the FDA.”
Gottlieb says the instances where FDA approval for such apps would be limited — the majority, including dose calculators, symptom trackers and medication reminders, would be treated as promotional labeling. “This would provide a more efficient path to market for these kinds of tools that can help patients be better informed about their medical care,” he says. ”As with more traditional forms of promotional labeling, drug sponsors would only have to submit copies of the content of what the apps display to end users to the FDA at the time of first dissemination, under the existing reporting requirements for promotional materials. For apps like these, we’re proposing a flexible approach and are seeking feedback on how we can continue to promote innovation in digital tools while making sure patients are protected.”
Gottlieb notes that the new proposal would not change the agency’s approach to digital health tools that are independently developed by software developers. The new framework would only apply to drug sponsors who choose to disseminate such software for use with one or more of their prescription drugs.