Law Firm Provides Overview of Guide on Drug Use-Related Software
FDA’s recent final guidance Regulatory Considerations for Prescription Drug Use-Related Software provides sponsors with a “more concrete framework for navigating the boundary between FDA-required and promotional labeling, while placing a premium on early regulatory planning,” according to a new Akin legal analysis.
The guidance 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. It 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 also 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, according to the agency. 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.
The Akin analysis draws attention to the guidance's Appendix A, a four-question decision tree intended to guide sponsors through the labeling analysis. “Software that does not satisfy the first two questions is outside the scope of the guidance,” it says. “Otherwise, the tree leads to one of three general outcomes: (1) FDA-required labeling with a description in the PI; (2) promotional labeling with a description of the software function in the PI; or (3) promotional labeling with no mention in the PI.”
In summarizing the document, the analysis notes: “Sponsors should consider whether software is device-connected or standalone; whether it is necessary for safe and effective use of the drug; what clinical evidence will support any proposed benefit; and whether the resulting content will be FDA-required or promotional labeling, along with any Form FDA 2253 obligations that may follow. FDA specifically recommends that sponsors work with the relevant review division early in development when they plan to generate clinical evidence supporting inclusion of software-related information in FDA-required labeling.”