The FDA has proposed a new plan to regulate digital tools developed by pharmaceutical companies, such as apps that offer medication reminders.
The framework outlines how the agency will oversee software "developed by, or on behalf of, drug sponsors for use in conjunction with one or more of their prescription drug products." It employs a risk-based approach, under which "in most cases, such software would not require review by the FDA prior to dissemination," according to an agency statement.
Under the proposed framework, the FDA draws a line between software that guides patients on how to use a company's prescription drugs and software that provides a therapeutic effect.
Many app displays and audio messages that offer information on medication use would fall into the category of "promotional labeling" under the proposed framework, subjecting them to existing post-marketing requirements — such as submitting copies of the content to the agency — but not necessitating FDA approval. These products might include dose calculators, symptom trackers or medication reminders.
By contrast, when a company argues that the software itself affects clinical outcomes, the agency will require the company to seek FDA approval.
"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. "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."
The FDA has opened public comment on the proposed framework through Jan. 19, 2019. To read the FDA's proposed framework or access instructions how on to provide feedback, click here.