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 : EC792
Submitter : Ms. Adele E. Zimmermann Date & Time: 10/13/2005 08:10:24
Organization : Ms. Adele E. Zimmermann
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. The product in question, Plan B, must not be marketed as a prescription drug based on the age of the user.
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. The product in question, Plan B, must not be marketed as a prescription drug based on the age of the user.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
No. The confusion exists only in FDA's desire to descriminate against users based on age.
C. If so, would a rulemaking on this issue help dispet that confusion?
No. There is no need for a rulemaking on marketing the same product as OTC and as prescription only. Plan B must be marketed solely as OTC.
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 issue is irrelevant in the case of Plan B. The product must be marketed solely as OTC.
B. If it could, would it be able to do so as practical matter and, if so, how?
The issue is irrelevant. See above.
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?
The issue is irrelevant. See above.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
The issue is irrelevant. See above.
GENERAL
GENERAL
Plan B is a contraceptive. It will eliminate the necessity for many abortions. To restrict OTC marketing to those (women) 17 and above only is discriminatory, both on account of age and of gender.

On account of age: a female 16 years and under is no less pregnant than one 17 and older. An unwanted pregnancy is no less devastating for young women than for older women. If you want to prevent the need for Plan B, then insure that complete knowledge of contraception is available to women of all ages. See that sex education is based on reality, not on moralistic fantasies. Lobby for adequate funding for Planned Parenthood.

On account of gender: Condoms are available solely as OTC. Men 16 years of age and under do not require a prescription for condoms. To require women 16 year of age and under to obtain a prescription to birth control is discriminatory.

Conclusion. Your quandery over the marketing of identical products as both prescription and OTC is moot. You must find another case for this precedent. Plan B may only be marketed as OTC. Any other resolution would be based on morality, not on medicine. Your only charter is for medicine.