2005P-0411
  

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

  


  

  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC333
  



  

  
Submitter : 
  

  
Mr. Alton Kelley
  

  
Date & Time: 
  

  
01/26/2006 02:01:28
  



  

  
Organization : 
  

  
APSI
  



  

  
Category : 
  

  
Drug Industry
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 To whom it may concern,



The phenomenon of "customization" that has become prevelant in all American idustries will inevitably make its way to pharmaceuticals. This despite evidence that pharmaceutical manufacturers  continue to reduce the options they are willing to manufacture."Customization" and "Mass Production" are about as far apart as any two business concepts can be. The very idea that a large manufacturer can, or would, make hundreds of different doses, delivery systems or combinations of drugs in order to meet individual needs, is immpossible to accept. 

This complaint by Wyeth while understandable from a business perspective,is absolutely without merit. Think about the process a patient must go through in order to receive a "compounded drug". First the Physician must be willing to prescribe a drug he knows has not been evaluated by the Food and Drug Administration in this form or delivery system, therby giving up the inherent protection that that provides. Secondly, the Pharmacist must agree with the Doctors customized approach and by doing so also assume additional liability in the event something the patient reacted badly. This process requires TWO trained and licensed medical doctors to rely on their expertise and agree before this drug is dispensed! It seems to me that this is the ultimate in safe drug slection. And think about the immediacy of the relief if a patient was ever harmed by a compounded drug. He/she would be working with a local attorney and seeking relief from a local doctor and pharmacy; not caught up in some class action that will take years and years to ever get to court. 

The hundreds if not thousands of Bioidentical Hormones Replacment Therapies currently being prescribed, are best handled on a case by case basis by licensed and trained Physicians and Pharmacist, not large scale manufacturers. There are many areas that the "one (or two) sizes fits all" approach will work - BHRT is not one of them! 

If the FDA were to disallow the dispensing of custom drug therapies many patients will be forced to take less than ideal drug choices. This is not what Congress intended when it created a body (FDA) to insure Americans had access to safe and effective drugs. If there was any basis in fact that Doctors and Pharmacist have been jeopardizing public health with these preparations I would say the FDA has a right, in fact a responsibilty, to adress the situation. "Market Share" however, seems to be what's driving the dispute here - rather than what is in the best interest of patients.

I strongly urge the FDA to ask Wyeth why it should intervene in what seems to be civil issue. The Federal Govenment is not supposed to take sides with one private company or industry over another! Tell Wyeth that as long as Physicians are writing prescriptions for compounded drugs and those custom preparations are not endagering the public health - you do not have a dog in this fight!



Concerned Citizen for Freedom of Drug Choice,



A. Samuel Kelley II