2005P-0411
  

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

  


  

  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC7013
  



  

  
Submitter : 
  

  
Ms. Jane Martin
  

  
Date & Time: 
  

  
03/06/2006 09:03:02
  



  

  
Organization : 
  

  
Ms. Jane Martin
  



  

  
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 Jane Carleton Martin, and I have been taking bio-

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

alleviates extreme menopause symptoms as a result of a hysterectomy.



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

for me, and my pharmacist prepares them.  Without this medication, I am a 

mess.  I can?t sleep. I have hot flashes every half hour or more. I can?t

think. I have poor memory. I cry all the time, completely drench three sets of pajamas per night with night sweats, I feel hopeless, I can?t work, in addition to feeling bloated, grouchy, etc., etc.



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,





Jane Carleton Martin

Walnut Creek, CA