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 : EC1116
Submitter : Ms. Diane Wahto Date & Time: 10/27/2005 02:10:11
Organization : Ms. Diane Wahto
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?
It's not necessary to market this Plan B two different ways.
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?
See above.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
I don't know what constitutes "significant confusion," but I'm not confused. Plan B prevents pregnancy after unprotected sex, thus eliminating a need for abortion.
C. If so, would a rulemaking on this issue help dispet that confusion?
Only if the rule would allow Plan B to be available to all women who need it when they need it.
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?
This should not be an option. The drug should be available over the counter, period.
B. If it could, would it be able to do so as practical matter and, if so, how?
It would be extremely impractical.
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?
It's not necessary to market Plan B two different ways.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
There's no need for two products.
GENERAL
GENERAL
Plan B should be made available OTC for all women where and when they need it. From the research I've done, it provides safe protection against pregnancy after a woman has had unprotected sex. Not to allow it will result in an increase in unplanned pregnancy, and therefore, abortions.