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 : EC646
Submitter : Mr. Raymond Settle Date & Time: 10/12/2005 06:10:53
Organization : Mr. Raymond Settle
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. It should remain one or the other but not both for drugs.
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?
No. The active ingredient is either safe enough for OTC or it's not. Both would be confusing.
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 because the basis of the confusion would remain.
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. Just look at the record of underage access to tobacco and alcohol.
B. If it could, would it be able to do so as practical matter and, if so, how?
See 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?
As long as the dosage was the same it wouldn't make any difference.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
See above.
GENERAL
GENERAL
I am opposed to the OTC sale of this product because just publicized data from England showed a significant increase in STD's after they approved OTC sales. As a parent, OTC sales to under 18 year old females encroaches on parental rights. It also makes no sense to me when birth control pills are prescription only yet you are proposing OTC sale of these higher dose pills. I can guarantee you that if you allow marketing these OTC to a certain age group, younger females will be able to obtain them.