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 : EC725
Submitter : Mrs. Feleiteau Epley Date & Time: 10/12/2005 06:10:42
Organization : Mrs. Feleiteau Epley
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?
NO
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?
NO
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?
NO
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, and if they could, older consumers would just buy for the younger consumers anyway.
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?
This would be very confusing. Also, you wouldn't be able to tell if it was aquired legaly.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
The prescription package indicates a doctor's advice.
GENERAL
GENERAL
The drug in question increases sexual promiscuity; which increases STDs and emotional problems for women and men. The drug in question also increases health risks for women and causes non-surgical early abortions of children. This drug should not be available at all, let alone over the counter!