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 : EC875
Submitter : Dr. Glenn Moore Date & Time: 10/17/2005 10:10:42
Organization : Women's Care Center
Category : Health Professional
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?
Yes
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?
yes
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?
hopefully it would
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?
Yes. We regulate to sale of alcohool and tobacco to minors. Why can't we regulate the sale ov OTC medications.
B. If it could, would it be able to do so as practical matter and, if so, how?
It would be practical and easy to do. Put the medication in the pharmacy and require the consumer to ask for it and produce an ID documenting the requirements have been met to obtain the medication.
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?
No. This would be confusing to the consumer.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
When they may interact with each other with an adverse outcome, or when the directions for use may be confusing regarding the second product.
GENERAL
GENERAL
Making Plan B available OTC without restrictions as to age of the user, or permission of the parent (with minors) is inappropriate. Any product that may encourage sexual activity in adolescents will only contribute to the increase in STI's and the HPV epidemic that already exists in this country.