Comments on Patient-Focused Drug Guidance

The Critical Path Institute says an FDA discussion document, appendices, and glossary for a guidance on patient-focused drug development “provides useful background information to entities like patient advocacy organizations that may have little experience with drug development and will be useful in that respect.” The institute’s comment letter contains comments and suggestions on various guidance elements.

Janssen says it applauds the agency’s approach to incorporate direct patient insights early and throughout the entire medical product development process and also applauds development of a discussion guide for the first draft guidance. The company calls on FDA to clarify whether it expects sponsors to use standard development meetings to engage with the agency on issues involving research objectives and methodology. “Assuming it does,” it adds, “we believe these issues may create additional burdens on those meetings and we believe FDA should consider setting up other mechanisms for expedited discussions on patient experience data questions, especially in the first several years while this topic is being explored.” The letter also includes specific responses to questions raised by FDA.

Also answering the agency’s questions were scientists working in the Patient-Centered Research group at Evidera and regulatory specialists in the PPD (Pharmaceutical Product Development) Global Product Development division. The letter makes suggestions on the structure, format, and content of the guidance. It suggests that FDA make explicit in the draft discussion document that the agency is open to discussion of the methods described and other methods, both within medical product development and in the pre-competitive space.