Drug Import Oversight to be Consolidated Under FDA Reorganization Plan

December 26, 2014

The FDA plans to consolidate its 16 districts overseeing pharmaceutical imports into either four or five districts under a reorganization plan that aims to make inspection policies and procedures more uniform, regardless of port of entry.

The consolidation is part of the agency’s Program Alignment Group initiative to reorganize investigators into specialized teams that will focus on individual product types — such as pharmaceuticals, devices or food — rather than on all FDA-regulated products generally.

It remains undecided how such product specialization will be addressed within import inspections, says Domenic Veneziano, director of the FDA’s Division of Import Operations. Import operations, however, will remain in the Office of Regulatory Affairs, he told a Food and Drug Law Institute conference on enforcement, litigation and compliance.

Under the reorganization, CDER and ORA also plan to create a strategy by fall 2015 to speed up the way they screen imports by creating risk-based import entry reviews that will allow the agency to identify adulterated products more quickly.

Veneziano says he doesn’t know when the reorganization of FDA import operations will be finalized under the PAG plan, but he’s confident the restructuring will make the agency more efficient.

One observer remains skeptical. The import district consolidation plan will create a more centralized bureaucracy, says Ben England, founder of FDAimports.com and a former regulatory counsel to FDA’s associate commissioner for regulatory affairs. It represents a further paring back of inspector discretion and power at the local level, and could make it more complicated for industry to resolve import issues, he says.

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