- FDA is seeking public comment on a proposed framework for regulating software applications, distributed by pharmas, that are designed to be used with their prescription drug products.
- The new approach would treat most prescription drug apps, including dose calculators, symptom trackers and medication reminders, as promotional labeling. The agency said it wants to support the development of such digital technologies, which it believes can guide the safe use of medicines to help patients improve their health, with an efficient path to market.
- The docket will be open until January 19, 2019 for stakeholders to submit comments about prescription drug-use-related software.
The proposal is in keeping with FDA’s aim of promoting digital health through such initiatives as its software as a medical device (SaMD) precertification pilot set to launch in 2019. Also known as the Pre-Cert program, it would allow the agency to pre-clear qualified companies to update software without agency review.
Top Democrats in Congress and some in industry have questioned whether the Pre-Cert plan can ensure medical device software accuracy and safety. Nine companies including Apple, Fitbit and Johnson & Johnson have been tapped to participate in the Pre-Cert pilot.
In describing the agency's proposed framework for regulating prescription drug-related digital tools, FDA Commissioner Scott Gottlieb said he expects there to be limited circumstances in which software designed for use with medicines would require FDA approval. The agency expects to treat the output of prescription drug apps, such as screen displays or audio messages, as promotional labeling. That means drugmakers would need only to submit to the agency copies of the content of what the apps display to consumers, following existing reporting requirements for promotional materials.
In other cases, such as when a drugmaker wants to show that software has an effect on a clinical outcome and wants to include information about the software in the FDA-required drug labeling, prior FDA approval would be required.
The agency said the proposal does not change the agency's approach to digital health tools that are independently developed by software developers.
"The FDA’s proposed approach, which treats certain software output as prescription drug labeling, does not alter the regulatory framework for what meets the definition of being a medical device," the agency wrote in the release. "The aim is to pursue a risk-based and least burdensome approach to these products to promote beneficial innovation that can promote healthcare goals and advance patient health and safety."