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 : EC655
Submitter : Mrs. Suzan Marcy Date & Time: 10/12/2005 06:10:51
Organization : Mrs. Suzan Marcy
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?
As a consumer and taxpayer, my question is: Why? If you are going to make this available as over the counter and it is the same strength and active ingredient as the "prescription", what is the point? To circumvent parental control? There is also the problem with monitoring side effects of those who purchase OTC drugs as opposed to prescription only. Are you ready to accept that somewhere down the line a 16 or 17 year old purchases OTC "morning after pill" and dies (as some already have)?
1.
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, it would only muddy the water further. The cost would be considerable.
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. It would be impossible to monitor whether the person purchasing the OTC drug was purchasing for themselves or for a "friend". The cost of trying to enforce this would be considerable.
B. If it could, would it be able to do so as practical matter and, if so, how?
As stated 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?
NO.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
Never.
GENERAL
GENERAL
This is a bad idea from the very beginning. How are you going to monitor the sales? Where is the money going to come from to enforce compliance? Why do you want to make certain drugs available to anyone under the age of 18, to circumvent parental control? These drugs are prescription only for a reason, they are dangerous if not taken according to the directions. This is not asprin we are talking about. This is not cold medicine ie; cough syrup or cold tablets. You are talking about the morning after pill which has already killed more than one young woman. How many more young women do you want to die? Are you ready to accept responsibility for that.