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 : 
  

  
EC28
  



  

  
Submitter : 
  

  
Ms. Candace Churchill
  

  
Date & Time: 
  

  
09/01/2005 04:09:45
  



  

  
Organization : 
  

  
Ms. Candace Churchill
  



  

  
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 Morning-After Pill for over-the-counter use as your own scientists have recommended 23-4.  The AMA and 70 other major health groups advocate otc for all women.  If a woman is old enough to get pregnant, she is old enough to take Plan B. She can read directions.

  


  

  


  

  


  

  



  

  
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 Morning-After Pill for over-the-counter use as your own scientists have recommended 23-4.  The AMA and 70 other major health groups advocate otc for all women.  If a woman is old enough to get pregnant, she is old enough to take Plan B. She can read directions.

  


  

  


  

  


  

  


  

  
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 approve Morning-After Pill for over-the-counter use as your own scientists have recommended 23-4.  The AMA and 70 other major health groups advocate otc for all women.  If a woman is old enough to get pregnant, she is old enough to take Plan B. She can read directions.

  


  

  


  

  


  

  


  

  
3
  


  

  



  

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


  

  



  

  
 The FDA should approve Morning-After Pill for over-the-counter use as your own scientists have recommended 23-4.  The AMA and 70 other major health groups advocate otc for all women.  If a woman is old enough to get pregnant, she is old enough to take Plan B. She can read directions.

  


  

  


  

  


  

  



  

  
GENERAL
  


  

  








  

  
GENERAL
  


  

  



  

  
 The FDA should approve Morning-After Pill for over-the-counter use as your own scientists have recommended 23-4.  The AMA and 70 other major health groups advocate otc for all women.  If a woman is old enough to get pregnant, she is old enough to take Plan B. She can read directions.