2005P-0411
  

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

  


  

  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC7020
  



  

  
Submitter : 
  

  
Mrs. Frances Shea
  

  
Date & Time: 
  

  
03/06/2006 09:03:25
  



  

  
Organization : 
  

  
Mrs. Frances Shea
  



  

  
Category : 
  

  
Individual Consumer
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 VIA FAX: (301) 827-6870

 

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 Frances Shea and I have been taking bio- identical hormones for nine years. It has been a tremendous comfort to me as it alleviates my menopausal symptoms.  



I consult with my physician, who prescribes bio-identical hormones specifically for me, and my pharmacist prepares them. Without this medication, I would be unable to sleep, endure mood swings, suffer debilitating hot flashes.  The quality of my life would be much diminished. 

( 

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,



 

Frances P. Shea 

Portland, Maine