2005P-0411
  

  

  


  

  

  


  

  
FDA Comment Number : 
  

  
EC792
  



  

  
Submitter : 
  

  
Mr. Richard Tramm
  

  
Date & Time: 
  

  
02/03/2006 04:02:03
  



  

  
Organization : 
  

  
Mr. Richard Tramm
  



  

  
Category : 
  

  
Individual Consumer
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 I am writing against the complaint of Wyeth. As a patient using bio-identical hormone replacement under the direction of a physician, I have recovered my health to a degree that was not achieved under other treatments recommended and attempted. Not only was my health and welfare recovered, but it was done so by supplementing the hormones my body already has, not by using drugs or synthetic hormones which are foreign to the body and potentially the cause of additional side effects.

As to the complaint of 'Flagrant Violations of the Law', I find this allegation laughable. The use of bio-identical hormaones is the use of substances native to the human body, not the introduction of foreign substances. It is the foreign substances which are drugs that are to be regulated not the hormones already within the body. To accept this complaint on this ground is the equivalent of accepting a complaint that the FDA is not properly regulating drinking water across the country.

Finally, I believe the FDA should also reject the complaint on grounds that, as a competitor, Wyeth is seeking to use the FDA to constrict or ban competitive access to the marketplace. This type of behavior is already well-documented to be illegal in a myriad of court cases in the courts of the United States.

Thank you.