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 : EC574
Submitter : Mr. John A. Vassar Date & Time: 10/12/2005 06:10:07
Organization : Retired
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. See "General Comments" below.
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?
Same as above.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
The matter of "confusion" is immaterial. See "General Comments" below.
C. If so, would a rulemaking on this issue help dispet that confusion?
Same as 1B above.
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?
Probably not, because you have no means of enforcement.
B. If it could, would it be able to do so as practical matter and, if so, how?
Same as in 2A 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?
Unknown.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
None. See "General Comments" below.
GENERAL
GENERAL
Making this product available OTC will provide the opposite effects that you intend among minors under the age 17. A recent study coauthored by Ms. Wendy Wright of Concerned Women for America, shows that pregnancies and surgical abortions among girls under the age of 16 actually increased, as did STD rates among the youth of Glasgow, Scotland. Chlamydia rose more than 40% while Gonorrhea was up by almost 50%. Unless you want these same things to happen here, keep the "Morning After Pill" prescription only for every one.