PDUFA Comments: FDA Should Zero in on Patient Perspectives

As the FDA ramps up its preparations for renewing PDUFA, industry and related groups are pushing for a greater focus on patient perspectives in its next iteration.

Five of the 13 comments the agency received on the planned update to the drug user fee bill focus on the agency’s current efforts to cultivate patient perspectives and preferences.

The general consensus among commenters is that the Patient-focused Drug Development Initiative is a good start, but the agency needs to apply that information to drug review and approval processes to ensure tangible results.