2005P-0411
  

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

  


  

  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC7486
  



  

  
Submitter : 
  

  
Mrs. Josefa Mandarino
  

  
Date & Time: 
  

  
03/06/2006 04:03:59
  



  

  
Organization : 
  

  
Mrs. Josefa Mandarino
  



  

  
Category : 
  

  
Individual Consumer
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 Dear Sir or Madam,



My comments are in reference to Wyeths petition (Docket #2005P-0411).  As a woman who has been using bioidentical hormones for 2 years, I can tell you that they have been far superior to their synthetic counterpart.  Both 'versions' were prescribed by my physician for me, the synthetic being the first hormone I tried, but it was unsatisfactory.  The second prescription was for the bioidentical and that has been tremendously helpful. It would be unacceptable and I believe it would jeopardize my health and level of comfort if my doctor could not prescribe the bioidentical formula for me.  I do not want my doctor's ability to prescribe a BHRT, my pharmacists ability to prepare it, or my ability to obtain it to be limited or restricted in any way.  I believe the FDA should reject Wyeth's petition.