2005P-0411
  

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

  


  

  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC7198
  



  

  
Submitter : 
  

  
Ms. Patsy McCleskey
  

  
Date & Time: 
  

  
03/06/2006 11:03:56
  



  

  
Organization : 
  

  
Ms. Patsy McCleskey
  



  

  
Category : 
  

  
Individual Consumer
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 I have been taking bio-identical hormones for ten years now.  I prefer the bio-identical hormones, as they are more like my body's natural hormones than other prescription options.  My doctor, Karen Birdy, prescribes the hormones and verifies that the dosages are correct for me by ordering and verifying the appropriate blood work.  I have relief from hot flashes and my sleep is improved.  

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

Sincerely,

Patsy McCleskey