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 : EC721
Submitter : Ms. Madeline Ashley Date & Time: 10/12/2005 06:10:10
Organization : Ms. Madeline Ashley
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?
This drug, Plan B should not be an over the counter product; it will promote promiscuity and IT KILLS AN UNBORN CHILD. They may state that the pill can only be sold to "women" 16 or over, but that won't hold water. Anyone will be able to get it by lying about their age.
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?
Sorry, I don't understand what is different about this question than the previous one. Anything you can do to prevent this drug from going on the market will be a benefit to society.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
Only those who want to be confused will be confused; i.e. those who promote abortion or want to make a pile of money on it!
C. If so, would a rulemaking on this issue help dispet that confusion?
Probably not.
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?
Probably not.
B. If it could, would it be able to do so as practical matter and, if so, how?
I don't believe you should even try--just get rid of Plan B.
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?
That sounds crazy to me.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
Under all circumstances
GENERAL
GENERAL
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