US FDA Office Of New Drugs Reorg: Phase 3 Pushed To January
Executive Summary
The FDA has confirmed the picks to head most of the new offices in the restructured drug review organization, with one notable exception. The choice for the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine is still pending, while one candidate – Hylton Joffe – will be serving as acting OND deputy director.
The next phase of the US Food and Drug Administration’s roll-out of a new structure for its drug review operations will take place in mid-January.
Phase 3 of the four-stage roll-out had been tentatively scheduled to take effect 2 December. However, the FDA announced 25 November that it would pause the process until after the holidays, and Phase 3 is now set for 13 January. The new timeline will “accommodate the high interest in leadership positions and scheduling interviews during the holiday season …This additional time also helps us to carefully finalize administrative activities and update applications/submissions.”
The FDA notes that “a large number of candidates have expressed interest and applied for division director positions.” The delay may also allow for the FDA to time division director announcements after some potential year-end retirements.
FDA implemented Phase 2 of the reorg in November, with the formal launch of the new Office of Neurology and the reorganized (and renamed) Office of Oncologic Diseases. (Also see "Drug Review Reorganization At US FDA Coming Into Focus" - Pink Sheet, 6 Nov, 2019.)
Phase 3 will include the Office of Specialty Medicine and the Office of Non-Prescription Drugs. “We are still on track for the final phase (Phase 4) to begin in the February/March 2020 timeframe,” the FDA says.
The agency has also confirmed the leadership for each of the new offices within OND, with one notable exception. The selection of the director of the new Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine is still pending. (See table at the end of the story.)
Hylton Joffe (current director of the Bone, Reproductive and Urologic Drug Products Division) and Lesley Furlong (deputy director of Office of Drug Evaluation IV) had been assigned the leads in setting up the new office, abbreviated as ORPURM. Joffe, however, is now on “detail” as the acting deputy director of OND (effective 3 December).
Julie Beitz – currently head of the Office of Drug Evaluation III and transitioning to head of the new Office of Immunology and Inflammation – has been acting deputy of OND.
In most cases the leads assigned during the reorganization process have been confirmed as leaders of the new offices, with a handful of exceptions. For example, Ed Cox was leading the Office of Infectious Diseases reorganization, but left the agency. Gideon Blumenthal was the lead on OOD, but is retaining his role as deputy in the Oncology Center of Excellence (with OCE head Richard Pazdur as head of OOD simultaneously).
Division of Dermatology and Ophthalmology Director Kendell Marcus had been working with ODE III Director Julie Beitz on the launch of the new Office of Immunology and Inflammation. However, while Beitz has been confirmed as OII Director, the deputy role is still pending.