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 : 
  

  
EC16
  



  

  
Submitter : 
  

  
Ms. Stephanie Smart
  

  
Date & Time: 
  

  
09/01/2005 04:09:01
  



  

  
Organization : 
  

  
Ms. Stephanie Smart
  



  

  
Category : 
  

  
Health Professional
  



  

  
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?

  


  

  


  

  



  

  
 A drug is not only its active ingrediant. It is a combination and has different uses based on the combination or the dosage. So yes, I think that a drug should be available by prescription and OTC containing the same active ingrediant.

  


  

  


  

  


  

  
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?

  


  

  


  

  


  

  
Same answer as above
  


  

  



  

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


  

  



  

  
No, but I do not agree with the interpretation.
  


  

  



  

  
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?

  


  

  


  

  



  

  
 I think this is a poor policy consideration. By limiting drug availabilty you open the door for discrtimiation based on race, age, gender, and socioeconomic status. The drug should be available to anyone who would have a usage for it based upon the labeling. 

  


  

  


  

  


  

  
3
  


  

  



  

  
 A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may the different products be legally sold in the same package?

  


  

  


  

  



  

  
 How could they be in the same package if they have different uses? Why would you have exactly the same product available by prescription and OTC? If an active ingrediant is available OTC and by prescription then wouldn't they automatically have different packaging becasue they would have different uses>

  


  

  


  

  


  

  








  

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


  

  



  

  
 What two products? This is not clear. If you are referreing to the above question it doesn't make sense. They wouldn't be in the ame package if one is by prescription and one is OTC.

  


  

  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 Please approve Plan B for OTC with no limitations on purchase. This is not Birth control. This is for emergencies and allows women a recorse when accidents occur such as a condom breaking. By allowing the sale of this product as an OTC item then you allow access to all socioeconimc classes of women.