November 19, 2018
“As the practical value of digital health technologies continues to advance, consumers are increasingly using these new tools to inform their everyday health decisions. Many of these advances have been on the delivery side of healthcare, where digital tools are helping inform medical decisions by patients and providers. As part of these opportunities, the FDA wants to promote the development of digital technologies that can also help guide the safe and effective use of medicines, to help patients improve their health,” said FDA Commissioner Scott Gottlieb, M.D. “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. 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. The FDA expects these circumstances to be limited and, 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. 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. 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. Our proposal does not change our approach to digital health tools that are independently developed by software developers. 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.”
Today, the U.S. Food and Drug Administration issued a Federal Register Notice “Prescription Drug-Use- Related Software” to announce the establishment of a docket to seek early input from the public on the agency’s proposed framework for prescription drug-use-related software. For the purposes of this framework, prescription drug-use-related software refers to software disseminated by or on behalf of a sponsor that accompanies one or more of the sponsor’s prescription drugs or biologics.
The proposed framework is designed to take a risk-based approach to prescription-drug-use-related software. Under this approach, it is anticipated that in most cases, such software would not require review by the FDA prior to dissemination. Generally, the output of such software products—screen displays or audio messages—would be regulated as promotional drug labeling and would be subject to existing post- marketing requirements for such labeling. In other cases, such as when a sponsor seeks to demonstrate that software has an effect on a clinically meaningful outcome and seeks to include information about the software in the FDA-required drug labeling, prior FDA approval would be required.
By providing more clarity around how these prescription-drug-use-related software products will be regulated—and by defining the most efficient pathway for these digital technologies while also ensuring that these tools meet the FDA’s current requirements—the agency hopes to promote development of these innovations. 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 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.
In deciding how the software should be most efficiently and effectively regulated, the proposed framework focuses on the output of software disseminated by or on behalf of a drug sponsor for use with one or more of its prescription drugs. 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.
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 docket will be open until January 22, 2019.
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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.