2005P-0411
  

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

  


  

  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC1767
  



  

  
Submitter : 
  

  
Mrs. Gail Tenzer
  

  
Date & Time: 
  

  
02/13/2006 02:02:21
  



  

  
Organization : 
  

  
Mrs. Gail Tenzer
  



  

  
Category : 
  

  
Drug Industry
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 Increasing health care costs are economically crippling our entire economy, as mentioned by President Bush in his State of the Union speech last night.



The interests of one company cannot take precedence over the common good.  Hormone Replacement Therapy has been responsible for increasing rather than decreasing health care costs by causing increases in cancer and other diseases as a consequence of the drugs' side effects.  



Wyeth's contention that Bio-Identical Hormone Replacement Therapy Drugs are endangering public health are false and self-serving, since these are prescriptions compounded at pharmacies upon the instructions of physicians who know what they are doing.  Many women cannot take HRT because of a familial history of cancer and thus are left with no other options in the absence of bio-identical hormones.



The FDA is supposed to protect the public and work for the public good and protect the public from harmful drugs, which is precisely what Wyeth has been marketing.  Free market forces were at work here where the public and health professionals have rejected products produced by Wyeth precisely because their drugs were harmful---and alternatives were chosen because they are not.



The FDA has enough trouble regulating drugs which may be harming the public where market forces have not taken care of the problem.  In this case, the FDA was spared the ordeal of ordering the withdrawal of Wyeth's drugs and taxpayers were saved a lot of money by not forcing FDA to go through that process.



I suggest that the FDA tell Wyeth that they cannot expect the FDA help them cure their losses for putting out inferior products that have been rejected in the market by legislating against their competition.  



Citizens and taxpayers should not be placed in a position of having no options other than to purchase the products of one company and it would not look good for the FDA to take a stance in favor of helping Wyeth with the problems they have with their bottom line.  Perhaps Wyeth should develop Bio-identical hormones to market and compete with compounding pharmacies, given that the public obiously prefers the latter to Wyeth's Hormone Replacement Therapy drugs which have fallen into public disfavor because of deleterious sequelae and causing iatrogenic illnesses.