Comment from Bower, Kaylin

This comment regards FDA docket FDA-2026-N-3947: "Impacts of Patient-Focused Drug Development Meetings; Established of a Public Docket; Request for Information and Comments": Per FDA documents released as part of the "Seife Report" regarding the egregious eteplirsen approval, I would like to highlight the following: Email from Christine McSherry of the Jett Foundation (a DMD "advocacy" organization) to Ed Kaye (Sarepta Therapeutics); Janet Woodcock and Grace Stuntz of the Senate HELP Committee were "cc'ed" on this email; this email was sent Monday, August 15, 2016 at 12:57 PM: See photos of this email as attachments Basically, this email is Christine McSherry "writing...to seek confirmation that Sarepta has submitted all of the data requested by the...(FDA) to complete its review of eteplirsen." The email "request[s] confirmation that Sarepta has submitted the data requested by the FDA, and the date by which it was submitted"; "encourage[s] Sarepta to release the formal communications the company has had with the FDA, including meeting minutes, letters, and other similar documents, as well as any other documents, data, presentations, or other materials that support the eteplirsen's NDA"; and thanks Ed Kaye "for your ongoing efforts to gain FDA approval for eteplirsen." This is NOT what "patient-focused development" is supposed to be, and this type of communication is extremely inappropriate! *I believe the "Grace Stuntz" "cc'ed" on this email is the current Grace Graham, policy commissioner at the FDA.*