While FDA has a long history of including the patient perspective through the FDA Patient Representative Program, where patients have been mainly included on Advisory Committees, patient engagement is a moving target. Legislation is one way for stakeholders and FDA to memorialize its efforts to expand the role of the patient in the FDA's decision-making. Under PDUFA V, FDA piloted the Patient-Focused Drug Development initiative as one way to increase the patient voice. Based on learnings from this “pilot”, FDA has been directed by the 21st Century Cures Act and PDUFA VI to host workshops and draft guidance on methods for collecting and processes for using information from patients.
This session will provide an assessment of FDA’s implementation efforts. Additionally, stakeholders and FDA staff will discuss current proposals for patient engagement as well as include an assessment of externally-led PFDD meetings, which took off in 2017, as FDA passed the torch to patient groups.

Ability Level: All

Session ID: 21028