Comment from Bower, Kaylin
AnonymousOpposeIndividual
Summary: The commenter opposes the proposed action, arguing that patient-focused drug development meetings allow for inappropriate relationships between FDA staff and patient advocacy groups. They cite the approval of eteplirsen as a disastrous example of how community influence can compromise evidence-based drug review processes.
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":
This information comes from FDA documents that were release as part of the "Seife Report":
-Email from Ellis Unger to John K Jenkins dated July 7, 2016: "In terms of overall involvement of Janet [Woodcock], my sense is that Janet reached the conclusion, perhaps back when the initial exciting immunohistochemistry data were announced, that the drug was effective. She has dialoged with the DMD community, and perhaps she has led them on...Given...her interactions with the DMD community...But she is trying to fit the data around her conclusions, instead of the other way around...".
-Email from John K Jenkins to Ellis Unger dated July 7, 2016: "I also do not see any reference to any concerns you may have about the motivation for JW's decision (e.g., inappropriate relationship with sponsor/parents)...if you have such concerns, you should voice them"
FDA leaders and/or staff should NOT be having "inappropriate relationship[s] with...parents," patients, patient advocacy groups, etc as part of NDA review processes! Such involvement is NOT and NEVER should be considered "patient-focused drug development"!
The FDA MUST learn valuable, critical and important lessons from the disastrous, debaucherous, egregious, harmful, non-evidence-based, and abominable eteplirsen approval! The FDA must NOT allow this type of "patient advocacy" community influence, "participation," "involvement," etc in the NDA process.