2006P-0001
  

  
Date of Approval for Lunesta (Eszopiclone) Tablets
  


  

  

  


  

  
FDA Comment Number : 
  

  
EC2
  



  

  
Submitter : 
  

  
Mr. Dave Lowe
  

  
Date & Time: 
  

  
02/02/2006 10:02:07
  



  

  
Organization : 
  

  
Mr. Dave Lowe
  



  

  
Category : 
  

  
Consumer Group
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 Given the flood of petitions from the drug industry, this has been posted electronically once to provide notice to HHS. This eventually applies to Lunesta.

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In any extention for any future patent terms for a human drug, antiobiotic drug, or human biological product, the Commissioner of Food and Drugs should consult with the Secretary of Health and Human Services, and if applicable, The United States Patent Office.



There is legal authority, including the Code of Federal Regulations (CFR), to determine if the applicant acted with due diligence during stated periods.  The Secretary of Health and Human Services must subtract days from the regulatory review period, depending on a determination.



If any of the above were marketed products for which consumers would find available and violative of CFR, due diligence was not followed. The Secretary of Health and Human Services must determine what actions constitute due diligence as defined.



If neccessary, FDA should consult with CBER and CDER to ensure recent issues of introducing drugs and biological products into interstate commerce prematurely are accurately addressed to the satisfaction of the Secretary of Health and Human Services, and eventually the United States Patent Office.



Any such violations of CFR should be addressed appropriately by FDA under CFR for human drugs, antibiotic drugs, and biological products.