- 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.
“There are currently many mobile applications (apps) available to consumers for a variety of health-related uses—such as tracking drug ingestion, monitoring certain medical conditions that require prescription drug medication, or providing information on how to use a drug—with more under development,” the FDA stated.
“Drug sponsors developing or obtaining rights to market software for use with one or more of their prescription drug products have approached FDA seeking clarity regarding the regulatory status of such software, referred to herein as prescription drug-use-related software.”
Prescription drug-use-related software is defined as an application created by the drug sponsor itself, not by a third-party developer, the FDA explained. These apps are designed to accompany the use of specific prescription drugs, offering information to guide the use of therapeutic substances.
“As the practical value of digital health technologies continues to advance, consumers are increasingly using these new tools to inform their everyday health decisions, said FDA Commissioner Scott Gottlieb, MD.
“Consider, for example…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.”
Apps with these functions would be classified as “promotional labeling” materials under the new framework, said Gottlieb, and would not need to undergo more extensive review and approval from the agency.
“Under the efficient framework that we’re proposing, we would treat the majority of prescription drug apps that may help patients, including dose calculators, symptom trackers and medication reminders, as promotional labeling,” he stated. “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.”
Drug sponsors would be required to submit copies of the app’s content to the FDA, as they do with more traditional promotional labeling materials, but would not need to engage further with the regulatory body unless the content is found to be problematic.
If, however, the app is intended to have an influence on clinically meaningful outcomes, the drug sponsor will have to submit the tool for more robust prior approval.
Applications that meet existing FDA definitions of a medical device will need to go through all current approval processes related to that higher-risk category, Gottlieb said.
Additionally, “our proposal does not change our approach to digital health tools that are independently developed by software developers,” he pointed out.
“This proposed framework only applies to drug sponsors who choose to disseminate such software for use with one or more of their prescription drugs. With this new proposal, our aim is to define an efficient path for the development of new digital tools that can help promote appropriate use of medicine to improve patient’s health.”
The proposal falls in line with other FDA efforts to create a safe and effective regulatory process without stifling innovation.
The agency has embraced the risk-based approach to deciding the degree of vetting for emerging categories of technologies, creating easier pathways to market for many types of digital health offerings.
Applications that actively analyze data, offer clinical decision support, or recommend actions to end-users are subject to varying degrees of scrutiny, but many popular consumer-facing tools that track input or provide reminders do not need approval, according to guidance released in 2017.
If the FDA’s prescription drug-use-related software framework proceeds as proposed, the vast majority of low-risk applications accompanying prescription therapies will also be able to bypass the review process, Gottlieb stated.
“With today’s notice of action, the agency intends to provide a clear and predictable pathway for stakeholders on the FDA’s approach to the regulation of software developed by, or on behalf of, drug sponsors for use in conjunction with one or more of their prescription drug products,” he said.
“The goal of this proposed framework is to advance a modern path for the efficient regulation of these products, as a way to promote development of tools that may help guide safe and effective prescribing. The FDA encourages stakeholders to provide comments to the docket about prescription drug-use-related software.”
The FDA will be accepting comments on the proposed framework until January 22, 2019.