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 : EC2100
Submitter : Ms. K Hollos Date & Time: 10/31/2005 06:10:23
Organization : Ms. K Hollos
Category : Drug Industry
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?
see cooments - last section
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 cooments - last section
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
see cooments - last section
C. If so, would a rulemaking on this issue help dispet that confusion?
see cooments - last section
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?
see cooments - last section
B. If it could, would it be able to do so as practical matter and, if so, how?
see cooments - last section
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?
see cooments - last section
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
see cooments - last section
GENERAL
GENERAL
EC is most effective (95%) if taken within 24 hours after unprotected sexual intercourse - when a condom breaks, birth control is not used, or if a sexual assault occurs. Forcing women to get a prescription before they can obtain Plan B is an unwise and unnecessary burden on all women, especially poor women who may not have access to a physician. Moreover, requiring a physician's prescription increases the total cost of EC dramatically.

The FDA's expert advisory panel recommended with a 23-4 vote that EC be made available over the counter without prescription almost two years ago. We cannot allow politics to interfere with women's health