2005N-0345
  

  
 Drug Approvals:  Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product

  


  

  

  


  

  


  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC694
  



  

  
Submitter : 
  

  
Ms. J Conroy
  

  
Date & Time: 
  

  
10/12/2005 06:10:59
  



  

  
Organization : 
  

  
Ms. J Conroy
  



  

  
Category : 
  

  
Individual Consumer
  



  

  
Issue Areas/Comments 
  


  

  


  

  
1
  


  

  



  

  
 A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC drug product?

  


  

  


  

  



  

  
YES- it should codify it's interpretation to make it clear that a prescription drug can NEVER be an over-the-counter drug at the same time.
  


  

  



  

  
1.
  


  

  



  

  
 A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding when an active ingredient can be simultaneously market in both a prescription drug product and an OTC drug product?

  


  

  


  

  



  

  
YES- it should codify it's interpretation to make it clear that a prescription drug can NEVER be an over-the-counter drug at the same time.
  


  

  


  

  
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
  


  

  



  

  
 The confusion is within the FDA itself -- it has forgotten that it's reason for existence is to PROTECT the public, NOT to 'get in bed' with big business!  Approving an over-the-counter (or even prescription) drug that has been PROVEN to lead to huge increases of venerial diseases and even to increase the number of abortions is NOT protecting the public!!!!!

  


  

  


  

  


  

  



  

  
C. If so, would a rulemaking on this issue help dispet that confusion?
  


  

  



  

  
Whoever has the brains to admit the truth; so far, that has not been the FDA.
  


  

  



  

  
2
  


  

  



  

  
 A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a matter of law?

  


  

  


  

  



  

  
No.
  


  

  


  

  
B. If it could, would it be able to do so as practical matter and, if so, how?
  


  

  



  

  
No.
  


  

  








  

  
3
  


  

  



  

  
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
  


  

  



  

  
All circumstances.
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 I do not want my health insurance and taxes increased to cover the 50% or higher increase of venereal diseases that will happen (as has already been proven in Scotland) if this travesty occurs.  Enough is enough already!