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Warning and Untitled Letters - Considerations

View PDF of Warning and Untitled Letters Section (26 KB)


Background 

Summary of Public Comments

Transparency Report Arrow Considerations

View All Warning and Untitled Letters Draft Proposals 


Considerations

The Task Force considered the utility of educating the public about violative practices or conditions at firms that market and/or distribute FDA-regulated products and alerting the public to these practices or conditions.  Disclosure of violative practices or conditions may increase public accountability of firms, which may deter future violations and increase compliance with the law.

The Task Force took into account the fact that in some circumstances, untitled letters include information about violations that may affect the safety or efficacy of medical products or the safety of the food supply.  Additional disclosure of these letters would provide the public with information that can be used to make more informed health decisions.  The Task Force also took into account that in other circumstances, an untitled letter is sent for relatively minor violations of the law. 

The Task Force considered the potential volume of this information, and whether the volume of the information would diminish the value of disclosing all untitled letters.  The Task Force considered that some Centers already disclose untitled letters on the FDA Web site, and the potential benefits of a consistent Agency practice in this area.