Comment from Bower, Kaylin
AnonymousOpposeIndividual
Summary: The commenter expresses concern that patient-focused drug development can lead to bias and undue pressure within the FDA's review process. They cite a memo highlighting how private conversations with stakeholders can undermine the integrity and trust of the drug approval team.
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":
Excerpts from this “Jenkins Memo” (email to Robert Califf from John K Jenkins dated September 14, 2016) will be quoted below to illustrate the fact that inappropriate involvement from the “patient advocacy community” can create bias in FDA approval decisions, among other negative consequences:
-”...Janet [Woodcock] has had frequent private conversations with the sponsor and the stakeholder community. To my knowledge, she has not documented the substance of those conversations to the record, as is required under FDA regulations…”
-”I think it is reasonable to question why she devoted so much attention to eteplirsen and not the other…drugs”
-”...her [Janet Woodcock’s] actions have at best created a serious appearance of bias among the review team members and that has created distrust and a sense of undue pressure to ‘come around’ to her way of thinking”
-”...what is not healthy is a situation where the actions of a leader creates the appearance of bias since this undermines the trust necessary for the review team to conclude that the action was fair and move on”
Conclusion: This is NOT the type of outcome that “patient-focused drug development” should create!