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 : EC750
Submitter : Mrs. stella milam Date & Time: 10/13/2005 08:10:47
Organization : Mrs. stella milam
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 should not be marketed in an over the counter product. It is dangerous to young girls, and will give them confidence that if they get pregnant, they can use plan B to get rid of the baby. Please, protect our children. The Plan B should remain a prescription only drug. It has done nothing to slow STD rates in countries where it is more readily available. Please, think of our future.
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 remain a prescription only drug. It should not be marketed over the counter.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
Yes, there seems to be.
C. If so, would a rulemaking on this issue help dispet that confusion?
A rule should be made regarding Plan B. It should not be sold over the couanter to anyone.
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?
Just make it a prescription only drug. Then you have solved the problem.
B. If it could, would it be able to do so as practical matter and, if so, how?
No
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?
No
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
It would be inappropriate to sell the drug over the counter. It will be misused.
GENERAL
GENERAL
We must think of society at large, and our civilization. Our girls need to know how dangerous Plan B is and it must never be marketed over the counter. Only prescription - though I would prefer it not be sold at all.