2005N-0403
  

  
 Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs

  


  

  

  


  

  


  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC10
  



  

  
Submitter : 
  

  
Mr. Robert Wallace
  

  
Date & Time: 
  

  
12/18/2006 10:12:59
  



  

  
Organization : 
  

  
NDC Working Group
  



  

  
Category : 
  

  
Drug Association
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 The NDC Working Group is composed of professionals from US pharmaceutical companies who are analyzing the proposed rule in terms of proposed changes to the NDC system and its effect on the pharmaceutical manufacturing and supply chain. Our goal is to provide the FDA with detailed documentation of the proposed NDC system changes and the effects such a change would have on US pharmaceutical marketing, manufacturing, distribution, and reimbursement.



The NDC Working Group requests that the FDA further extend the comment period on this proposed rule for the following reasons:



* FDA held a public hearing on proposed changes to the NDC system on 11 December 2006. In that hearing, presenters from several industries affected by the proposed rule testified to the impact that NDC system changes would have on their company or industry segment. Such information, now made public, provides significant context for commenters that was not available prior to the meeting.



* Although the proposed rule was docketed in August 2006, the public hearing was held in December. The public hearing provided valuable context for the pharmaceutical industry and stimulated responses and recommendations that would otherwise not be considered solely on the information provided in the agency's proposal.



* The NDC Working Group provides a forum for pharmaceutical representatives to share NDC system experience and expertise. Because pharma companies are organized in many different ways, a comprehensive industry-wide review of the NDC cannot be provided through comments from a single pharmaceutical company. The Working Group officially formed on 30 November 2006 and requires additional time to develop a salient response with recommendations for the FDA.



The NDC Working Group respectfully requests that the agency extend the comment period for no less than 30 calendar days, to give the Working Group and other affected parties time to craft informative, reasoned, comprehensive responses and recommendations on this very important issue. Further, the Working Group commends the FDA for its evaluation of the drug-listing process and current NDC system, and supports the FDA in its efforts to increase the safety and accountability in the US drug-product distribution chain.