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 : EC657
Submitter : Mr. James Thompson Date & Time: 10/12/2005 06:10:22
Organization : Mr. James Thompson
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?
Maybe
B. If it could, would it be able to do so as practical matter and, if so, how?
Not sure, It could be done by age groups, but that might mess up the legal ramifications.
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?
YES
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
As long as the buyer could understand the risks and that they are stated on the package.
GENERAL
GENERAL
the so-called morning after pill should not be sold OTC. It is too dangerous to be issued under that status and parental notification for 18 or under should be the rule. Three girls/women have already died using the the so-called morning after pill in this country (USA)and the parents did not know they were given it until after they had died.