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Enforcement Priorities and Actions - Considerations

View PDF of the Enforcement Priorities and Actions Section (38 KB)


Background

Summary of Public Comments

Transparency Report Arrow Considerations

View All Enforcement Priorities and Actions Draft Proposals   


Considerations
The Task Force considered that the public interest is served when interested individuals can assess how FDA protects the safety of medical products and the food supply. 

The Task Force considered whether additional disclosure would improve industry compliance with FDA requirements and help deter actions that could result in the marketing of products that harm the public. 

The Task Force considered the accessibility of enforcement-related information, noting that information about enforcement actions are often public but may not be readily accessible by the public.  The Task Force noted that the public is not able to get a complete picture of the court cases filed against FDA-regulated entities, and the results of those actions. 

The Task Force considered the effect that additional public disclosure about pending and planned enforcement actions would have on FDA’s ability to enforce the law.  The Task Force took into account the importance of frank deliberations among FDA employees about the merits of pursuing a particular enforcement action. 

Further, the Task Force recognizes that disclosure of preliminary information, before FDA has decided to take an enforcement action and while the issue is still under investigation, may unfairly prejudice the company or individual at issue, particularly if the FDA’s final determination is that no enforcement action is warranted. 

The Task Force considered the risk that disclosing detailed information about the FDA’s planned enforcement priorities and activities may be used to circumvent the law.  The Task Force took into account the fact that FDA’s priorities and plans must be adaptable and able to shift in response to public health emergencies that may arise.