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 : EC752
Submitter : Ms. Prudence Humber Date & Time: 10/13/2005 08:10:15
Organization : Alpha Pregnancy Services
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?
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?
No
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?
I have been working with teens regarding sexuality for 18 years. Allowing this powerful combination of hormones to be sold OTC to 17 year-olds would be meaningless in preventing 16 year-olds or younger from getting and using without adult consent/supervision. It is a no-brainer that older children will purchase it for younger children indiscriminately.
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 comment
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
No Comment.
GENERAL
GENERAL
If the FDA allows these rule changes, it will be operating as an ostrich which buries its head under volumes of meaningless rules and paperwork. If the FDA is truly enlightened about human behavior, it will unanimously reject the idea of making allowances for age groups. Furthermore, how can the FDA self-righteously limit muscle building steroids from any age group or gender in the name of good health, yet think that it is okay to advocate that women can use abnormally large doses of hormones at will. You are discriminating against women in your offering these harmful hormones without the guidance of a health professional and/or parent.