Show Notes
Pink Sheet Executive Editor Derrick Gingery, Senior Editor Sue Sutter and Senior Writer Cathy Kelly discuss the limited impact the US Centers for Medicare and Medicaid Services’ Global Benchmark for Efficient Drug Pricing (GLOBE) model after it was finalized with only a handful of participants (:58), as well as several other questions still being asked about it (10:24). They also consider the impact of the Food and Drug Administration eliminating voting privileges for some advisory committee consumer representatives (15:15), the Health and Human Services Department eliminating some of the FDA’s legal oversight (24:13), and the FDA reopening its search for a cell and gene therapy office director (27:28).
More On These Topics From The Pink Sheet
Shrinking GLOBE: Medicare Part B Model Seems Increasingly Unlikely To Advance: https://insights.citeline.com/pink-sheet/market-access/pricing-debate/shrinking-globe-medicare-part-b-model-seems-increasingly-unlikely-to-advance-2MFLVAIRWRG7JDEZQP2AQ7VZMY/
Possible GLOBE Participants Down To Four ... And Counting: https://insights.citeline.com/pink-sheet/market-access/pricing-debate/possible-globe-participants-down-to-four-and-counting-4UYTIWXLRNAMXEIR7JNTRCNR3Q/
US FDA Wants Advisory Committee Members, But Not Voting Consumer Reps: https://insights.citeline.com/pink-sheet/product-reviews/us-advisory-committees/us-fda-wants-advisory-committee-members-but-not-voting-consumer-reps-5V4SKVJFB5FJLG2GPKKZJXZVLY/
Reorg Cuts US FDA Chief Counsel Oversight Position At HHS: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/reorg-cuts-us-fda-chief-counsel-oversight-position-at-hhs-5VPOXSOOLRCCVPGWEI2XECL6UE/
US FDA Continues Search For Cell, Gene Therapy Office Director, Lowers Education Requirement: https://insights.citeline.com/pink-sheet/advanced-technologies/cell-and-gene-therapies/us-fda-continues-search-for-cell-gene-therapy-office-director-lowers-education-requirement-IXJCWUATZBHKZLOTNFSCJBOHYE/
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Pink Sheet Executive Editor Derrick Gingery, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs discuss the reasons Iilun Murphy, director of the US Food and Drug Administration’s Office of Generic Drugs, decided to step down (:53) and whether the move should concern senior agency officials (2:51). They also consider the FDA’s plan to create a fit-for-purpose rare disease approval framework (12:19), how it will connect with the agency’s litany of programs for the products (14:52) and the potential difficulties of systematizing regulatory flexibility (18:22).
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