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 : EC654
Submitter : Mr. Peter Kortebein Date & Time: 10/12/2005 06:10:36
Organization : Mr. Peter Kortebein
Category : Individual Consumer
Issue Areas/Comments
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, if the benefit is clearly defined to those who would benefit from such an interpretation.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
Yes, when applied to the particular application concerning "Plan B".
C. If so, would a rulemaking on this issue help dispet that confusion?
It would help to clear up the issue regarding the controversy over age of the women and why those older than 16 "benefit" from OTC status and those under 16 might be harmed by OTC status.
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?
Enforcement would obviously be the main issue and should raise the question of the reality of those doctors who would make such drugs available under pressure from parents of minor women who may have conceived a child.
B. If it could, would it be able to do so as practical matter and, if so, how?
No, it would not be able to monitor the use of such drugs adequately as a practical matter.
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?
It would not make a difference if the packaging contained language that indicated that two applications existed for the same product.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
This question would be resolved by the debate in a rulemaking discussion.
By all means the product in question should be correctly termed an abortifacient, since it can act to prevent the implantation of a fertilized egg into the uterine wall, and the product labeling should contain such information. This raises the question as to why it was approved in the first place since it is a lethal drug.