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Warning and Untitled Letters - Draft Proposal 21

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


Background

Summary of Public Comments

Considerations

View All Warning Letters Draft Proposals

View Comments for this Proposal


Average Rating for this proposal (Based on 4 Ratings):
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Draft Proposal

FDA should post untitled letters on the FDA Web site, and, if requested by the recipient of the letter, the response to the untitled letter, as appropriate.


Reasoning: Information in untitled letters reflects problematic practices of regulated firms and individuals and potential public health risks associated with FDA-regulated products.  The public has an interest in learning about firms and individuals that violate the FDCA because that information may inform decisions about whether, or from whom, to purchase a product.  Further, similarly situated regulated entities can use this information to determine what activities and practices FDA finds violative, and use the information to modify behavior. 

Not all of the information provided in untitled letters reflects problems with FDA-regulated products that may pose a direct risk to the public health.  But the public may benefit from improved compliance with the law by regulated firms due to the accountability generated by public disclosure of this information.  Transparency about these violative practices and conditions will allow the public to make more informed decisions about the use of FDA-regulated products and further the goals of the Administration for more openness in government


Comments for this proposal 

(Total Received: 4)

Comment: This is a good idea because it will let people know that any problems with the manufacturing of medicines or medical equipment is being taken care of by FDA and the manufacturer. It also gives an additional insentive to the manufacturer to make sure high standards of quality control are in place and are being used.
Date Submitted: 5/22/2010
Comment: CRN is concerned that if the agency were to post all untitled letters and, if requested by the recipients of the letter, the responses to the untitled letters, the volume of the information would be overwhelming and diminish the value of posting information about violations. The combination of warning letters and untitled letters would hinder the ability of the public to tease out important information that may help it make more informed decisions about the use of FDA-regulated products.
Date Submitted: 7/19/2010
Comment: I agree with the CRN comments. Also, making untitled letters public may change the way FDA writes them, making them less useful.
Date Submitted: 7/20/2010
Comment: We have concern over "untitled" letters - verification of authenticity as per whistleblower standards to prevent slander
Date Submitted: 7/20/2010