2005P-0411
  

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

  


  

  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC264
  



  

  
Submitter : 
  

  
Ms. Tammy Folsom
  

  
Date & Time: 
  

  
01/26/2006 08:01:07
  



  

  
Organization : 
  

  
Premier Pharmacy
  



  

  
Category : 
  

  
Health Professional
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 I am appalled that a pharmaceutical company, namely Wyeth, can file a complaint in the name of  Citizens!  It seems apparent that the Wyeth Citizens' Complaint is in fact Wyeth's complaint. 



In response to Wyeth's Complaint I would like to state my concern over eliminating an individual's right to choose.  The decision to take compounded hormones should be a decision made by the physician and the patient, working together in the best interest of the patient's health. The overall number of women who have tried (Wyeth's) commercially available hormones and then switched to bio-identical hormones and experienced an improved outcome is unknown to me, but I do know that in my personal practice the numbers are vast.  I have been witness and heard testimony of women?s improved quality of life associated with the use of bio identical hormones.  In every instance, they have been under a physician's care and the prescription has been compounded according to state law and with safe practice according to USP guidelines and according to state pharmacy laws.  Additionally, each prescription has been compounded and dispensed to the ultimate patient pursuant to a valid prescription.



If  Wyeth's true complaint is one of patient safety, then I submit to you that it is another issue altogether.  Rather than an altruistic concern for the safety of the public, Wyeth's concern is for the safety of the bottom line and the happiness of their stockholders.



Sincerely,

Tammy Folsom