2005P-0411
  

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

  


  

  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC1649
  



  

  
Submitter : 
  

  
Dr. Romeo Mariano
  

  
Date & Time: 
  

  
02/13/2006 12:02:59
  



  

  
Organization : 
  

  
Dr. Romeo Mariano
  



  

  
Category : 
  

  
Health Professional
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 I am a physician, psychiatrist.  



I do NOT support limits on a compounding pharmacist's ability to provided necessary low-cost generic medications to my patients.  



Bio-identical hormones are GENERIC medications which are NOT often available to patients because no commercial drug company will market them.  They are not patented - thus have no value to a large drug company.  Bio-identical hormones are exact duplicates of human hormones. They cannot be patented.  They are always generic.



Progesterone, for example, has been generic since the 1950s.  It is only available in 100 and 200 mg sizes - often too large a dose and too expensive for my patients (up to $140 or more a month).  A compounding pharmacy can make any dose size and at much less expensive cost than the commercial brand ($25-50 per month for a dose equivalent to the commercial brand).  



Testosterone, for example, is a generic medication.  The commercial forms are available in men's strengths - not women's strengths.  They are also expensive (e.g. $180 per month).  A women's strength capsule of testosterone can cost $10.59 from a compounding pharmacy - a huge discount compared to the commercial brand. 



Note that Premarin - the most commonly used commercial estrogen substute in the U.S. is half-human and half-horse estrogen with about 100 contaminants.  The half-human part is an estrogen more likely to cause cancer in women.  It is far safer to use a bio-identical (i.e. exact human duplicate) hormone such as estradiol and estriol in a compounded, custom made medication for a woman - the estriol estrogen actually reduces the risk for breast cancer.



Note that it is the artificial progesterones - the Progestins - such as that used in PremPro - which is to blame for causing heart attacks and strokes in women.  The artificial progesterones do not protect against heart attack, stroke, blood clots like the natural bio-identical (exact human duplicate) progesterone.  The bio-identical progesterone is a much safer medication than any artificial progesterone - any progestin - such as those made by large commercial drug companies.



It is important to keep these low cost generic medications available to the patients who need them - particularly at a time when the cost of health care keeps rising.  



To keep compounded bio-identical generic hormone medications out of the market would leave only the more costly - and more dangerous artificial hormones - on the market.