2005P-0411
  

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

  


  

  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC7139
  



  

  
Submitter : 
  

  
Mrs. Lynda Ingle
  

  
Date & Time: 
  

  
03/06/2006 10:03:41
  



  

  
Organization : 
  

  
Mrs. Lynda Ingle
  



  

  
Category : 
  

  
Individual Consumer
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 Dear Sir or Madam:



My name is Lynda Ingle and I have been taking bio-identical hormones for 8 years.  It has been a tremendous comfort to me as it alleviates hot flashes and mood swings.



I consult with my physician, who prescribes bio-identical hormones specifically for me, and my pharmacist prepares them.  Without this medication, I am forced to use HRT drugs which make me very depressed.  With the BHRT prescribed for my individual needs, I can adjust it daily as needed.  If I am under extra stress, I can increase my dosage and have immediate relief.  If I don't need it for a while, I can decrease my dosage.  I cannot do this with the HRT drugs.



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,

Lynda Ingle

Gore, VA