FDA Guidance on Drug-Related Software, Labeling Requirements
FDA has finalized a guidance entitled Regulatory Considerations for Prescription Drug Use-Related Software that outlines how prescription drug manufacturers should address software applications used with their products, including when claims about the clinical benefits of such software can be included in FDA-approved drug labeling.
The guidance addresses mobile applications and other software that supplement or provide information about prescription drugs and drug-device combination products. The recommendations apply to software distributed by or on behalf of drug sponsors, regardless of whether the software is separately regulated as a medical device.
FDA says software used with prescription drugs can support activities such as tracking medication administration, providing individualized dosing recommendations, predicting treatment responses and managing adverse effects. The guidance establishes an evidence-based framework for determining whether information generated by such software should be treated as FDA-required labeling or promotional labeling.
A main consideration is whether the sponsor has demonstrated that using the software with a prescription drug produces a meaningful improvement in a clinical outcome compared with using the drug without the software.
Under the guidance, sponsors wanting to include such claims in a product’s prescribing information should provide evidence from one or more adequate and well-controlled studies. FDA said these studies may incorporate real-world data, as appropriate, to generate real-world evidence supporting effectiveness claims.
When FDA determines that software provides a meaningful clinical benefit, information about the supporting studies generally should appear in the Clinical Studies section of the drug's prescribing information. Associated software outputs would generally constitute FDA-required labeling, and certain subsequent changes would require FDA review and approval, it says.
The guidance distinguishes between device-connected software, which receives information directly from a device or device component, and standalone software, which may rely on information entered by patients or healthcare professionals.
For example, software connected to an inhaler or autoinjector might track medication use and transmit information to a mobile application. FDA recommends that prescribing information briefly describe such capabilities even when the sponsor has not demonstrated an additional clinical benefit.
In those circumstances, however, the software's output generally would be considered promotional labeling rather than FDA-required labeling. FDA also recommends that prescribing information clarify when use of the software is optional and unnecessary for the drug's safe and effective use.
Standalone software that has not demonstrated a meaningful clinical benefit and is not essential to safe and effective drug use generally should not be described in the prescribing information, according to the guidance.
FDA emphasized that software-generated information considered promotional labeling remains subject to existing requirements governing prescription drug promotion, including prohibitions against false or misleading claims and requirements for submission of promotional materials to the agency.
Additionally, the guidance addresses the submission and review of software-generated content, including updates to information displayed to patients and healthcare professionals.