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 : EC602
Submitter : Mrs. Carolyn Mulligan Date & Time: 10/12/2005 06:10:55
Organization : Mrs. Carolyn Mulligan
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?
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?
No
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?
No
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 only contribute to the problematic enforcement issues.
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 always be inappropriate to do so
GENERAL
GENERAL
The morning-after pill should not be sold at all, let alone without a prescription. Many studies have indicated an *increase* in the rates of both abortion and STDs when the morning-after pill has been made available to the subject population. And making it non-prescription based on an arbitrary age limit will have the same result as age limits on alcohol - if someone wants it, they will get it, either through the use of a false ID, bribery of someone in the approved age group, or a black market. This is common sense, and should be the overriding consideration in the FDA's decision.