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 : EC1567
Submitter : Mr. Sean Bagley Date & Time: 10/31/2005 11:10:13
Organization : Mr. Sean Bagley
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?
FDA should immediately approve over the counter Emergency Contraception devices. A majority of medical professionals and organizations verify the safety of these products and the benefits to women of having emergency contraception available over the counter.
1.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
The only confusion is from the FDA blocking immediate over the counter access to Emergency Contraception for women of all ages.
C. If so, would a rulemaking on this issue help dispet that confusion?
Quit stalling. Womens contraception should be a right and the FDA stalling is only serving to keep women from being able to make their own choices on contraception/pregnancy matters.
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?
FDA should not limit sale of OTC products to certain sub-populations. FDA should immediately make these products available to all women who desire the products. No, FDA would not be able to enforce such limitation, nor would it be ethical for them to do so.
B. If it could, would it be able to do so as practical matter and, if so, how?
Irrelevant. Emergency contraception should be immediately made available to all women and the FDA should quit stalling to prevent such products being made available to women.
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?
Making EC universally available would eliminate the need for separate packaging.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
It would not be inappropriate in that there need be no double standard or restrictions on women who choose Emergency Contraception from having it available to them, regardless of age or any other criteria.
GENERAL
GENERAL
Enough already. Emergency Contraception products should be allowed on the market over the counter for all women. FDA should stop blocking these valuable products from the women of America.