FDA Sets Leadership for New Office of Import & Enforcement Operations
The Food and Drug Administration is still working out the details of its reorganization and the creation of a new Office of Enforcement and Import Operations (OEIO), but has put into place the leadership for the new office. OEIO will be overseen by the new Office of Operations, which will in turn report to the associate commissioner for regulatory affairs.
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Melinda Plaisier, currently director of FDA’s Central Region office, will take over as associate commissioner for regulatory affairs, said an FDA spokeswoman. The current associate commissioner, Dara Corrigan, will be moving to Brussels to become director of the Europe office and senior adviser for Global Operations. Roberta Wagner has been appointed senior advisor to the associate commissioner to “ensure continuity of leadership on key initiatives and priorities,” the spokeswoman said.
Ellen Morrison, formerly director of the Office of Crisis Management, has taken over the post of acting assistant commissioner of the Office of Operations, the spokeswoman said. The Office of Operations will oversee all four new operational offices, which include OEIO, the Office of Food and Feed Operations, the Office of Medical Products and Tobacco Operations, and the Office of Regulatory Science.
Ricky Rodriguez, Jr., formerly director of the FDA Dallas district office, has been named acting director of OEIO, the FDA spokeswoman said. According to an internal FDA fact sheet, the OEIO will combine much of the Office of Enforcement's Division of Compliance Management Operations and Division of Compliance Information and Quality Assurance and the Office of Regulatory Affairs’ Division of Import Operations and Policy.
FDA declined to comment at this time on how the reorganization will affect importers of FDA-regulated products.
(See ITT’s Online Archives 12091902 for summary of FDA’s Sept. 10 fact sheet on the reorganization and the creation of OEIO. Email documents@brokerpower.com for a copy of the fact sheet.)