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 : 
  

  
EC36
  



  

  
Submitter : 
  

  
Mrs. Anita vanHeeswyk
  

  
Date & Time: 
  

  
09/01/2005 04:09:48
  



  

  
Organization : 
  

  
Mrs. Anita vanHeeswyk
  



  

  
Category : 
  

  
Individual Consumer
  



  

  
Issue Areas/Comments 
  


  

  


  

  
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?

  


  

  


  

  



  

  
 FDA SHOULD NOT ENFORCE...I strongly believe that the role of the FDA is to determine the safety and efficacy of a drug....NOT enforcement.  The concerns being discusses re: age of consumer with this drug seem to be based on personal ethics, not at all an issue of drug safety.  I have heard of parents incorrectly using OTC products for newborn diaper rash such as Tinactin with out a physician's recommendation....where is the concern.  I know that you are aware of MANY more abuses of OTC drugs.  I am a Christian with strong religious beliefs, but I am also strongly of the belief that currently some government agencies are are confusing religious beliefs with scientific fact. 



If the drug works and is not harmful let it be OTC.  Abuse, if it happens, should then be dealt with as with as with phenylproponolamine, as well at tobacco and alcohol.