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 : EC584
Submitter : Ms. Margaret Victor Date & Time: 10/12/2005 06:10:40
Organization : Ms. Margaret Victor
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?
FDA should not make this product over the counter. Look where we've ended up with Sudafed and other cough medicines.
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?
It should not do anything but prohibit the sale of this monsterous product.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
The confusion is that you are even considering allowing this product to be sold over the counter.
C. If so, would a rulemaking on this issue help dispet that confusion?
Only when you act as moral human beings will the confusion desist.
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?
There should be no subpopulation. It should not be allowed.
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?
Not sold at all. You can already get it from the doctor, why should it be over the counter? So it makes killing babies easier.
GENERAL
GENERAL
This is an abomination. Until this country recognizes that abortion is killing we will continue to become less of a worldwide leader.