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Enforcement Prioirities and Actions - Summary of Public Comments

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


Background

Transparency Report Arrow Summary of Public Comments

Considerations

View All Enforcement Priorities and Actions Draft Proposals   


Summary of Public Comments
Comments asked FDA to provide more information about enforcement actions on the FDA Web site in a timely, understandable, accessible manner.  For example, some comments suggested that FDA include information about court cases filed and the final result of those cases in the weekly publication, FDA Enforcement Report.  Another comment encouraged FDA to “continue and expand” the Agency’s practice of publishing links to press releases issued by the United States Attorneys Offices about cases that involve FDA-regulated products.  One comment suggested that debarments of individuals and companies, and disqualifications of clinical investigators should also be listed in the FDA Enforcement Report.  One comment requested that FDA publish the names of firms under investigation by the Agency and another comment requested that FDA post information on any investigations of products that may not be safe to eat or safe to use.

One comment suggested that FDA provide information about the timeline for further enforcement action on the FDA Web site.  Another comment stated that FDA should share trends in enforcement actions and discuss the rationale for those actions with relevant scientific groups during public meetings. 

Comments requested more information about FDA’s decision-making process regarding a decision to pursue an enforcement action.  A comment requested information about the facts relied upon by FDA when determining whether to pursue an enforcement action.  An industry group suggested that “FDA can do a better job explaining its operations and activities by making available a multi-year strategic plan and companion operational plan describing the tactics and objectives the agency plans to achieve.”

Comments requested more information about the resources FDA allocates for enforcement activities.  For example, comments suggested that FDA provide “detailed budget and staffing figures at the program level,” “detailed employment information for these programs, such as number of inspectors,” and “information on the size of the various communities subject to FDA regulation.”