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 : EC1094
Submitter : Ms. Mary Monahan Date & Time: 10/27/2005 12:10:53
Organization : Ms. Mary Monahan
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. The FDA has misinterpreted section 503(b).
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?
Again, no.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
Apparently only in the leadership of FDA.
C. If so, would a rulemaking on this issue help dispet that confusion?
A rulemaking would muddy the water, and make the FDA look more foolish than it does now.
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 rational court would tolerate such nonsense.
B. If it could, would it be able to do so as practical matter and, if so, how?
Any young woman who is facing an unwanted pregnancy will find someone or some way to purchase Plan B. Those unfortunate or naive enough not to manage to get ahold of Plan B will suffer the fate that precocious young women women have suffered for the last several centuries. It is difficult to control the sale of alcohol and tobacco to those mandated by law to be too young, and they are sold in relatively large packages. A
couple of pills are easy to hide and have no tell-tale odor. The lack of a pregnancy is not going to set off alarms in anyone who sees the young woman.
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?
If the dosage instructions are the same, which they should be, there's no problem with identical packages.

Different packages (with identical ingredients and instructions) would tell the public that the FDA has something to hide.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
It is not "two" products.
GENERAL
GENERAL
The mandate of the Food and Drug Administration vis-a-vis drugs is to ensure that drugs sold in the US (both prescription and over-the-counter) are safe and effective. Plan B has been used in the rest of the world with an admirable safety record, and there are no restrictions placed on the age of the purchaser or intended user.
The mandate of the Food and Drug Administration is not to shove an arbitrary moral code down the throats of American women.