Thursday, August 6, 2009

FDA Commissioner: Six new compliance initiatives

FDA Commissioner Hamburg today:

Compliant industry should support these intitatives that will prevent them from being undercut by firms taking illegal shortcuts:

  • 15 days for FDA to issue Warning Letters. Warning letters will no longer be held waiting for firms to respond.

  • No GC reviews unless the case presents a novel legal issue. The Bush adminsitration policy of having letters reviewed by anti-consumer activitists planted in the Agency offices is cancelled.

  • State coordination where state law allows rapid response to seize products and correct issues.

  • A Warning Letter or recall will trigger enforcement follow up. Cases will no longer be allowed to languish or remain open with incertain resolution. Firms will get a knock on the door and an inspection.

  • No multiple warning letters. The second Warning Letter to a firm will trigger increased scrutiny and follow up actions.

  • After Warning Letter is satisfactorily resolved, firms may be eligible for a "close out letter" to document the matetrs have been resolved, e.g., after an FDA inspection.

Also she mentioned FDA has asked for additional power to mandatory food recalls.

The full text of the speech will be available immediately following the event here.

A video recording of the speech will be available after 4:00 this afternoon here.

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