Comment from Bower, Kaylin

This comment regards FDA-2026-N-3947, "Impacts of Patient-Focused Drug Development Meetings; Establishment of a Public Docket; Request for Information and Comments": From: Summary Review for Eteplirsen (206488Orig1s000, Application Number, CDER): "An additional factor in this situation is the emergence of patient-centered drug development and the extensive interactions with the patient community as part of the overall environment for development and decision-making. While the appropriate methods for patient-centered drug development are evolving, the fact that DMD involves vulnerable children with a life-threatening illness and understandably concerned parents produces significant pressure on all involved. This dynamic is well reflected in Dr. Unger and Dr. Woodcock's documents. With a significant history dating back to the development of drugs for HIV/AIDS, patient-focused drug development is not an entirely new component of FDA's regulatory processes, and it remains an explicit CDER priority in the current era" (page 7) I STRONGLY and VEHEMENTLY disagree with Dr. Califf's words here. To call the DMD "patient advocacy community's" involvement in the eteplirsen approval process is NOT what patient-focused drug development should be. If it is the case that what the FDA wants PFDD to be is that "patient advocacy," political pressure, etc can influence and make FDA NDA decisions, then the FDA should disband the PFDD program/department and replace it with a rubber stamp for NDAs-just give these "patient advocacy" communities and politicians what they want-approvals. Does PFDD mean that the FDA should waive, distort, ignore, or disregard the statutory requirements for NDAs? Because that is what clearly appears to have happened in the approval of eteplirsen (absolutely egregious, in my view). Is PFDD simply giving patients what they want, which is approvals, even if the NDAs do not meet the FDA's statutory requirements for approval?