2005P-0411
  

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

  


  

  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC7097
  



  

  
Submitter : 
  

  
Mrs. Judith Watson
  

  
Date & Time: 
  

  
03/06/2006 10:03:19
  



  

  
Organization : 
  

  
Mrs. Judith Watson
  



  

  
Category : 
  

  
Individual Consumer
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 Dear Sir or Madam:

My name is Judith Watson and I have been taking bio-identical hormones for 4 years. It has been a tremendous comfort to me as it alleviates my Addison's Disease. I also take bio-identical drugs for hormone replacement therapy.

I consult with my my physician who prescribes bio-identical hormones specifically for me, and my pharmacist prepares them. Without this medication I would be suffering the side effects of prednisone. I also would be suffering the side effects of traditional hormone replacement. I do not have any of the side effects with the bio-identical drugs. I feel so much better and I'm not near death's door as I was with the Addison's Disease. Without these drugs I would be unable to work and live a full life. I have been working now for the past three and a half years.

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. As a concerned citizen, I make my petiton. 

It is apparent to me that Wyeth has made this petition because they cannot own the patent on these drugs and thus these bio-identical hormones are in competion to their product. I have experienced a safe effective strategy to handle my Addison's Disease and hormone replacement with bio- identical drugs, I do not feel that Wyeth has my best interests at heart when it's motivated by competition and the bottom dollar. I do not want my right to take bio-identical hormones to be jeopardized by a drug company who may not have my best interests at heart.

Sincerely,



Judith Watson

State College, PA