2005P-0411
  

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

  


  

  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC7385
  



  

  
Submitter : 
  

  
Ms. melissa ward
  

  
Date & Time: 
  

  
03/06/2006 03:03:31
  



  

  
Organization : 
  

  
Ms. melissa ward
  



  

  
Category : 
  

  
Individual Consumer
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 Division of Dockets Management

Food and Drug Administration

5630 Fishers Lane, Room 1061 (HFA-305)

Rockville, MD, 20852  



RE: Docket 2005P-0411



Dear Sir or Madam:



 My name is Melissa Ward  and I have been taking bio-

             

identical hormones for over ten years.  It has been a tremendous comfort to me as it                                           



alleviates the multitude of horrible symptoms related to PMS and menopause such as 



hot flashes, night sweats, irritability, rapid heartbeat, headaches, loss of sexual desire, 



weight gain and  depression.                          

 

I consult with my physician, who prescribes bio-identical hormones specifically 



for me, and my pharmacist prepares them.  Without this medication, I would doubt my 



sanity, feel miserable, look miserable and not enjoy the quality of life that I do now 



in personal relationships and work performance that I do while taking bio-identical 



hormone therapy.

 

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




  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  








  

  
 Sincerely,







Melissa Ward

 



Santa Monica, CA