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 : EC803
Submitter : Mr. Timothy Laws Date & Time: 10/13/2005 08:10:58
Organization : Mr. Timothy Laws
Category : Individual Consumer
Issue Areas/Comments
B. If it could, would it be able to do so as practical matter and, if so, how?
This is obviously extremely unlikely, as the widespread prevalence of alcohol consumption by minors demonstrates. Considering that there is seventy odd years of building an enforcement mechanism on the underage drinking issue, involving participation by virtually the entire law- enforcement establishment of every state, yet it still is only marginally effective, it is totally unrealistic to assume that a pioneer establishment of such a regime for one particular drug will be even remotely successful.
Allowing over-the-counter sales of PlanB would permit convenience stores and neighborhood shops to sell this dangerous drug to minors: legally to those over sixteen years of age, and illegally to those under sixteen. The use of alcohol and tobacco by minors convincingly demonstrates that this scheme would be abused often, resulting in the deaths of countless preborn children -- through the anti-implantation effect of Plan B; and injury to many ?- with death for some ?- of their mothers. Obviously, many purchases of this product will be made by boys and men, to be forced upon their girlfriends and abuse victims, either by physical intimidation or the emotional variety -- against which adolescents and children have very limited defenses.

Putting Plan B on over the counter status would be a grave offense against American children.