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 : 
  

  
EC18
  



  

  
Submitter : 
  

  
Ms. Susan Nowak
  

  
Date & Time: 
  

  
09/01/2005 04:09:38
  



  

  
Organization : 
  

  
Ms. Susan Nowak
  



  

  
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?

  


  

  


  

  



  

  
 The FDA should approve and allow over-the-counter sales of Plan B "The Morning After Pill" immediately.  Plan B has been proven safe and effective for emergency backup protection and has been used overseas in Europe safely for years.  Women in the US should have the same rights to their reproductive freedom as women in Europe.  It is long overdue.  Please support and approve this ASAP.  No more delays.



Thank you,

Susan Nowak

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  



  

  
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?

  


  

  


  

  



  

  
 The FDA should approve and allow over-the-counter sales of Plan B "The Morning After Pill" immediately.  Plan B has been proven safe and effective for emergency backup protection and has been used overseas in Europe safely for years.  Women in the US should have the same rights to their reproductive freedom as women in Europe.  It is long overdue.  Please support and approve this ASAP.  No more delays.



Thank you,

Susan Nowak

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  



  

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


  

  



  

  
 The FDA should approve and allow over-the-counter sales of Plan B "The Morning After Pill" immediately.  Plan B has been proven safe and effective for emergency backup protection and has been used overseas in Europe safely for years.  Women in the US should have the same rights to their reproductive freedom as women in Europe.  It is long overdue.  Please support and approve this ASAP.  No more delays.



Thank you,

Susan Nowak

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

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


  

  








  

  
 The FDA should approve and allow over-the-counter sales of Plan B "The Morning After Pill" immediately.  Plan B has been proven safe and effective for emergency backup protection and has been used overseas in Europe safely for years.  Women in the US should have the same rights to their reproductive freedom as women in Europe.  It is long overdue.  Please support and approve this ASAP.  No more delays.



Thank you,

Susan Nowak

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  



  

  
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 should consider having the pharmacists dispense the Plan B after viewing ID, such as a drivers license to ensure that the consumer is the legal age, 16 or over.  Very similar to that of buying alcohol, except the product is available behind the pharmacy counter and all the consumer needs to do is ask the pharmacist and show proof of appropriate age. 

  


  

  


  

  


  

  


  

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


  

  



  

  
 The FDA should consider having the pharmacists dispense the Plan B after viewing ID, such as a drivers license to ensure that the consumer is the legal age, 16 or over.  Very similar to that of buying alcohol, except the product is available behind the pharmacy counter and all the consumer needs to do is ask the pharmacist and show proof of appropriate age. 

  


  

  


  

  


  

  


  

  
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?

  


  

  


  

  



  

  
 Why would you want to do this?  The products should be kept separate and what does this have to do with making Plan B, specificaly, available over-the-counter for those 16 and older?

  


  

  


  

  



  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 The FDA should approve and allow over-the-counter sales of Plan B "The Morning After Pill" immediately.  Plan B has been proven safe and effective for emergency backup protection and has been used overseas in Europe safely for years.  Women in the US should have the same rights to their reproductive freedom as women in Europe.  It is long overdue.  Please support and approve this ASAP.  No more delays.



Thank you,

Susan Nowak