2005P-0411
  

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

  


  

  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC7338
  



  

  
Submitter : 
  

  
Ms. Lance Moore
  

  
Date & Time: 
  

  
03/06/2006 02:03:48
  



  

  
Organization : 
  

  
Ms. Lance Moore
  



  

  
Category : 
  

  
Individual Consumer
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 

February 22, 2006



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 Lance Moore.  I have been taking bio-identical hormones for approximately three years.  It has been a tremendous comfort to me as it 

alleviates my low-hormone condition.

 

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

for me, and my pharmacist prepares them.  Without this medication, I would have to spend hundreds of dollars out of pocket rather than tens to get my health needs met. Without them, I would likely have to self-inject, which is a painful process and much more likely to lead to infections than using the gel I am able to acquire because of my independent compounding pharmacy. I am truly grateful they and their products exist.



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,







Lance Moore

352 N. 16th St.

San Jose, CA 95112