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Enforcement Priorities and Actions - Draft Proposal 4

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


Background

Summary of Public Comments

Considerations

View All Enforcement Priorities and Actions Draft Proposals

View Comments for this Proposal


Average Rating for this Proposal (Based on 2 Ratings):  

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Draft Proposal

FDA should post on its Web site all Agency Workplans (i.e., the annual Office of Regulatory Affairs Annual Field Workplan) that are older than five years, starting with the FY 2001 Workplan.

Reasoning: The public interest is served when interested individuals can assess how FDA protects the safety of the medical product and food supply.  But disclosure of information about FDA’s planned enforcement priorities may provide the public with information that allows regulated industry to more easily avoid detection and circumvent the law. 

ORA Workplans should be disclosed after a certain amount of time has passed.  Due to changing circumstances, it is highly unlikely that information from older workplans will allow individuals to predict how FDA would prioritize enforcement resources now.  In other words, after a certain period of time has passed, the risk that regulated industry or individuals could use the information in the workplan to evade the law is substantially mitigated.  Workplans from five years ago and older are sufficiently attenuated from FDA’s inspection priorities now and can be disclosed.

Historical ORA Workplans provide the public with a better understanding of how FDA allocates limited resources to protect the public health and furthers the goal of the Administration to increase the public’s knowledge of FDA and its operations.  FDA has an interest in protecting contemporaneous enforcement data and Agency priorities (i.e., information within five years of the current year), but posting older ORA Workplans serves the public interest without compromising FDA’s current enforcement activities.


Comments for this proposal 

(Total Received: 2)

Comment: Enforcement actions and the Enforcement Report are key tools in ensuring safe and effective medications. It is important to include what cases have been transfered to the Department of Justice for civil or criminal action and the outcomes of court trials and appeals. It is also important to include when a situation was handled by the agency administratively without use of the court system.
Date Submitted: 5/22/2010
Comment: CRN supports the posting of all Agency Workplans that are older than five years. The Draft Proposal suggests that these postings would start with the FY 2001 Workplan. CRN is a trade association that represents dietary supplement manufacturers and ingredient suppliers. FDA regulations of dietary supplements were significantly modified as a result of the passage of DSHEA in 1994. The dietary supplement industry waited over 14 years for FDA to release Good Manufacturing Practices (GMPs) for dietary supplements and is still waiting for the agency to release a guidance document for New Dietary Ingredient Notifications (NDINs). There is much confusion and speculation as to why the agency has taken so long for these important guidelines and what agency priorities have dictated such timelines. CRN requests that all Agency Workplans that are older than five years, starting with the FY 1994, be posted on the website.
Date Submitted: 7/19/2010