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 : EC656
Submitter : Mr. N. Alfred Balmer Date & Time: 10/12/2005 06:10:04
Organization : Christ Luthran Church
Category : Drug Industry
Issue Areas/Comments
The questions posed above may be necessary from a legal viewpoint but from a viewpoint of practical consequences they are not germane. Permitting such a drug to be sold OTC may have an unforseen consequences, that is, an actual INCREASE in teen-age promiscuity and pregnancy. For the male will tell the female that she has nothing to worry about physically or socially, that is, in regard to parents and peers--she can just get rid of it, the conception. Also the females may decide to keep the unborn child, that is, change her mind from the heat of the moment, because she wants the child. For God created women to conceive and bear children. This maay not be true with all females. Nevertheless, it is a reality for the majority.