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 : 
  

  
EC24
  



  

  
Submitter : 
  

  
Mr. Aaron Salvo
  

  
Date & Time: 
  

  
09/01/2005 04:09:22
  



  

  
Organization : 
  

  
Mr. Aaron Salvo
  



  

  
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?

  


  

  


  

  



  

  
 Currently there are several products that are available over the counter that are typically categorized as controlled substances, but there are also similar prescription productions. For example certain dosages of Ibuprofin are available by prescription only, but lower dosages can be purchased under brand names such as Advil, and there is nothing stopping a consumer from taking a single dose of the non-prescription strength product that would equal or even exceed the prescription dose. Also cigarettes are known to contain Nicotine, which is a narcotic, but Nicotine is now available as an OTC product in forms such as Nicorette Gum. Neither of these products have caused the FDA any consternation.

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  
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?

  


  

  


  

  



  

  
 Again, there are currently products that are available in an OTC and perscription form. So yes that FDA should allow an active ingredient to be simultaneously marketed in both an OTC and prescription form.

  


  

  


  

  


  

  
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?

  


  

  


  

  



  

  
 The FDA has enforced the sale of certains drugs without the assistance of a perscription. Once again alcholic beverages and cigarettes come to mind. A perscription is not needed for either product, yet the FDA limited access to these products by people below a specific age. Even though drinking ages are regulated by the states, there is at least precedence in law to keep a product out of the hands of a certain sub-population.

  


  

  


  

  


  

  



  

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


  

  



  

  
 The practicality of enforcement would be difficult, but no more than existing products available in both forms. As mentioned in previous questions a consumer may purchase an OTC Ibuprofin and take a single dose that would equal the perscription strength. Recently, however, certain states have take action to put certain OTC cold medications behind the phramacy counter and only releasing them in certain quantities to people 18 or older. Putting both forms behind that counter would allow an individual to get the required medication and put the oneous of enforcement on the store to verify that it is legal to dispense the product. Again much in the same way that people are "carded" for alcohol and tobacco products. 

  


  

  


  

  


  

  


  

  


  

  


  

  








  

  
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?

  


  

  


  

  


  

  
 In short I see no reason why separate packages would be needed. A person who could not legally purchase the product without a perscription would be stopped before leaving the store, unless they had a perscription. 

  


  

  


  

  



  

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


  

  



  

  
I see no time that it would be inappropriate to sell the two products in a single package.