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 : EC688
Submitter : Mrs. margaret radigan Date & Time: 10/12/2005 06:10:57
Organization : Mrs. margaret radigan
Category : Health Professional
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?
yes.
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?
yes
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
yes
C. If so, would a rulemaking on this issue help dispet that confusion?
yes
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?
No. I see no way that this type of rule could or would be inforced
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?
never
GENERAL
GENERAL
This product should be sold only under a professional's supervision by prescription. There is no reason this product should be available over the counter. Easy access to a product such as this will lead to promiscuity, and an INCREASE in sexual activity in the younger generation. This drug should be for EMERGENCIES!!!!, and not as a form of birth control as I beleive it will become for many woman if available over the counter. This country's morality is crumbling; and I urge all involved parties to restrict the use of this product so that millions of women and teens do not see an easy way to have carefree sex without consequences.