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Recalls - Draft Proposal 18

View PDF of the Recalls Section (61 KB)


Background 

Summary of Public Comments

Considerations

View All Recalls Draft Proposals

View Comments for this Proposal


Average Rating for this proposal (Based on 5 Ratings):

star ratingstar ratingTransparency Report Half Star

Draft Proposal
When a system is set up that provides FDA with authority to require companies to submit certain information to the Agency when they initiate an action to recover or correct a product that is in the chain of distribution, FDA should disclose this information as soon as practicable after receiving this information from the firm.

 

Reasoning: Where a recall is being conducted voluntarily, FDA cannot require recalling firms to submit to the Agency specific information about a defective or otherwise violative product on the market, and therefore, FDA may not be able to provide the public with information it may deem important for the public to know about a recalled product. 

Due to the current limitations of the Agency’s authority and its implications for FDA’s ability to protect the public health, FDA should seek authority that would require manufacturers and distributors to inform the Agency when they initiate an action to recover or correct a product that is in the chain of distribution due to a defect with the product, or is believed to be in violation of FDA laws and regulations. 

If recalling firms are required to provide FDA with basic information about every recall, including: the identity of the product that is being recovered or corrected, the estimated number of medical products (e.g., number of tablets or devices) or food items that are subject to recovery or correction, the reason for the action to recover or correct the product, and the geographic distribution of the product, FDA quickly could provide that information to the public, enhancing the Agency’s ability to protect the public health.  In addition, FDA could provide the public with consistent messages whenever an FDA-regulated product was recalled.

FDA is in the best position to ensure that useful, actionable information is provided to the public about a problem with an FDA-regulated product so that consumers can make informed decisions in response to a recall announcement.  In addition, with ready access to key information about a recalled product, health care providers can better evaluate a patient’s condition and provide appropriate care. 


Comments for this proposal 

(Total Received: 5)

Comment: This is very important and very needed to prevent any possible contamination taking place in the supply chain.
Date Submitted: 5/22/2010
Comment: A very important proposal. It's hard to believe that FDA does not already have the needed authority.
Date Submitted: 7/17/2010
Comment: CRN is concerned that if the Agency receives additional authority on recalls, which may require manufacturers and distributors to inform the agency when they initiate an action to recover or correct a product that is in the chain of distribution. If companies are required to provide additional information such as identity of product, estimated number in distribution, reason for action, and geographic distribution, the result may be that companies raise the threshold for initiating corrective action and discourage recalls in situations where urgent action might be needed. A company may hesitate to initiate a corrective action for a minor container defect of label misprint—a situation that does not pose a risk of adverse health effects— due to fear of potential confusion caused by this information being immediately made available to the public by FDA. In addition, if the public is made aware of every corrective action, no matter how minor, they may become overburdened with information
Date Submitted: 7/19/2010
Comment:In addition, if the public is made aware of every corrective action, no matter how minor, they may become overburdened with information and start to ignore FDA’s attempts to communicate information about important recalls that do have potential for serious adverse health threats to the public (Class I and Class II recalls). Therefore, CRN does not support Draft Proposal 18
Date Submitted: 7/19/2010
Comment: This soujds like it could lead to chaos, if things are disclosed early then changed, then changed again, rather than being reported when more details are known.
Date Submitted: 7/20/2010