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 : 
  

  
EC15
  



  

  
Submitter : 
  

  
Ms. Laura Marshall
  

  
Date & Time: 
  

  
09/01/2005 04:09:50
  



  

  
Organization : 
  

  
Ms. Laura Marshall
  



  

  
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?

  


  

  


  

  



  

  
 Codifying an interpretation can only help--make it clear exactly why and when a drug is being marketed OTC and Rx at the same time, and make it clear that the reasons are not political but medical.  Ibuprofen, ranitidine and other histamine receptor agonists, many drugs are currently sold OTC and prescription, but the issue there is about dosage, not a moral determination.

  


  

  


  

  


  

  



  

  
1.
  


  

  



  

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


  

  



  

  
I would say so; confusion and rumor, not to mention bad PR for the FDA.
  


  

  



  

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


  

  



  

  
 Yes.  Make it clear what the determiners are of such decisions; that will make it easier on the FDA and clearly more of an issue of fact than politics.

  


  

  


  

  


  

  
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?

  


  

  


  

  



  

  
 As a matter of law, perhaps, but fake IDs and passing on of a prescription legally purchased would make the reality different.  And the likelihood is that making it harder to get for a specific subpopulation would engender lawsuits, more court cases, and further confusion as non-medical angencies and entities enter into the process.

  


  

  


  

  


  

  



  

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


  

  



  

  
See Above.
  


  

  


  

  
GENERAL
  


  

  








  

  
GENERAL
  


  

  



  

  
 Please try to keep politics out of the drug-approval decision-making process.  I don't know the FDA charter, or the regulations binding its decision, but my guess is that nowhere in those documents is there any requirement that so-called moral factors be taken into account.  There are moral arguments on both sides of this issue, and the best middle ground is factual and scientific when the matter is, itself, a factual and scientific matter.  Is the drug safe for the population it will be sold to?  Is it effective?  Is it, perhaps, already available off-label?  Those are the questions the FDA should answer, not whether it's either moral to sell or politically expedient.