2005P-0411
  

  
 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs 

  


  

  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC7110
  



  

  
Submitter : 
  

  
Ms. Gundula Lee
  

  
Date & Time: 
  

  
03/06/2006 10:03:14
  



  

  
Organization : 
  

  
Ms. Gundula Lee
  



  

  
Category : 
  

  
Individual Consumer
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 My name is Gundula Lee and I have been taking bio-identical hormones for ten years.  It has been a tremendous comfort to me as it alleviates vaginal symptoms of menopause.



I consult with my physician, who prescribes bio-identical hormones specifically for me, and my pharmacist prepares them.  Without this medication, I would not be able to walk or exercise without extreme discomfort/pain.  In addition, my marital relations would be non-existent.



The benefit of BHRT is that it is designed for me and I am concerned that Wyeth's petition (Docket # 2005P-0411) would limit the ability of my physician and pharmacist to keep prescribing and preparing these individual doses for me.  The FDA should reject Wyeth's petition.