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 : EC636
Submitter : Ms. Maura Mudd Date & Time: 10/12/2005 06:10:43
Organization : Ms. Maura Mudd
Category : Individual Consumer
Issue Areas/Comments
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, the FDA has no power to enforce such a limitation.
B. If it could, would it be able to do so as practical matter and, if so, how?
No. It would be up to ill-qualified, minimum-wage employees, who have no training in enforcement to keep the product out of the hands of a subpopulation. In other words, such a limitation is,in all practicality, unenforcable. Children would be able to obtain and abuse the product. They would also be able to use the "liquor store model" to obtain the product, ie. they could easily get an older friend/sibling/lover or a person willing to make a quick $5.00 to buy the product for them.
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?
This is irrelevant. If the product, with little effort, is accessible OTC, why would anyone bother to get a prescription?
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
I'm the mother of 2 young girls (ages 11 and 12). How would you at the FDA protect my daughters from Plan B, if it were OTC? What would stop my daughters from paying a stranger $5.00 to buy the drug for them and then using it as a daily/weekly birth control pill?

If this were to happen, what would be the effect of frequent use of Plan B on a young, developing female body? If physical harm occurred,
who would be liable? The company who manufacuted the drug or the FDA who made it easily accessible to young children?

I think you shouldn't approve Plan B for OTC use unless you can, in good conscience, answer these questions. To pretend that requiring an ID will prevent teenage abuse of the drug is to pretend that requiring an ID stops teenage abuse of alcohol. A prescription is a lot harder for a teenager to obtain than a fake ID.