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 : EC632
Submitter : Ms. Amy Seymour Date & Time: 10/12/2005 06:10:25
Organization : Ms. Amy Seymour
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?
I don't think that this would be enforceable. Making a certain medication available to certain subpopulations via prescription only would not only be impracticable, but would also smack of discrimination. In the case of Plan B, allowing this to be an OTC medication for ANY population would not be in the best interest of ANY subpopulation of women because the ones to whom the marketing of Plan B would be targeted (i.e., younger, less-educated women who would be less likely to go to their doctor for a prescription for Plan B in a timely manner) are the very women who would be hurt the most by the potentially dangerous AEs of Plan B and who might not seek medical care quickly enough if an AE is experienced. As one who has always subscribed to feminist ideals and who cares deeply about the health and well-being of ALL women, I think that allowing Plan B to be an OTC medication would be a HUGE and very damaging mistake, one for which too many young, naive women will end up paying too high a price.