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 : EC1708
Submitter : Ms. Amy Miller Date & Time: 10/31/2005 02:10:45
Organization : Ms. Amy Miller
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, it would only confuse matters even more.
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?
EC should be OTC for all ages. Trying to enforce this law would be a waste of tax dollars and an intrusion on girl's privacy. It's embarrassing enough to buy tampons when you're a teenager. Being forced to show ID for EC is a ridiculous idea.
B. If it could, would it be able to do so as practical matter and, if so, how?
No practical way to enforce this. What, are you going to have armed guards in every drug store, intimidating teenage girls?
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?
Sure.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
there are no circumstances where it would be inappropriate to sell the two products in a single packages.
GENERAL
GENERAL
We need EC to be OTC for everyone. This will reduce teenage pregnancies and abortions. We should be striving to reduce abortions. Restricting EC so that teenagers can't get it OTC is going to force many to seek abortions. There is no valid reason why it shouldn't be OTC for everyone. Teenagers deserve a second change. If they are seeking EC, they've already made a mistake. Why is the government being so hard on them by not giving them a safe, effective out? After a scare like that, they are apt to become more responsible. and the evidence clearly suggests that they will NOT become promiscuous just because EC is OTC.

Please make EC available OTC for EVERYONE!!