2005P-0411
  

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

  


  

  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC7416
  



  

  
Submitter : 
  

  
Ms. Jean Brady
  

  
Date & Time: 
  

  
03/06/2006 03:03:19
  



  

  
Organization : 
  

  
Ms. Jean Brady
  



  

  
Category : 
  

  
Drug Industry
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 I have been using bio-medical hormone therapy (BHRT) for over two years, since 

I stopped taking the Estrogen Replacement Therapy (ERT) pills.   The topical cream has been a tremendous comfort to me as it alleviates hot flashes and other menopause symptoms without having to take the ERT pills internally.

  

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

for me, and my pharmacist prepares them.   After taking the ERT pills for over 10 years, I feel safer using the BHRT topical cream, and it cost a lot less for the prescription.

 

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 individualized doses for me.  The FDA should reject Wyeth?s petition.



Sincerely,



Jean Brady 

6047 Montgomery Bend

San Jose, CA  95135