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": I will cite the following information from the Scientific Dispute Resolution Appeal regarding Eteplirsen dated August 8, 2016, written by Dr. Luciana Borio, MD, Acting Chief Scientist to Robert Califf, MD, Commissioner of Food and Drugs as an example and warning of what patient-focused drug development is NOT supposed to be!: "During the SDR Board's separate interviews of Dr. Unger and the review team member (RTM), the SDR Board learned that, at Dr. Woodcock's direction, the review team also joined her in meetings with patient advocacy groups for DMD on multiple occasions-anywhere from six to twelve times-from very early on in the review process. The RTM described the meetings with the patient advocacy groups, which frequently included boys with DMD and their parents, as 'intense,' 'personal,' and 'intimidating.'... (page 9) "In their interviews with the SDR Board, Dr. Unger and Dr. Woodcock stated that FDA also received significant correspondence from the public and Congress, much of which urged approval of eteplirsen. Some of the correspondence used vulgar language and was abusive to the review staff" (p 10) "He (Dr. Ellis Unger) also highlights the negative effectives that accelerated approval would have on the patients themselves, including false hope, abandonment of other therapies, and a decline in drug development for DMD...Finally he (Dr. Ellis Unger) worries that approving eteplirsen based on the data submitted to the sponsor 'would send the signal that political pressure and even intimidation-not science-guide [] FDA decisions'" (p 18) "...in light of the public and political pressure evident during the entire review process at CDER..." (p 27)