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 : EC599
Submitter : Mr. Colin Donovan Date & Time: 10/12/2005 06:10:07
Organization : Mr. Colin Donovan
Category : Individual Consumer
Issue Areas/Comments
B. If it could, would it be able to do so as practical matter and, if so, how?
To make the distinction on the basis of age is to abdicate responsiblility, or rather, to provide a fig-leaf to the conscience of the regulators that somehow underage girls will not get this drug, despite the fact that underage boys and girls have succeeded quite easily in getting alcohol and tobacco, drugs ostensibly kept from them by age restrictions.
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?
Only if you want to encourage their unregulated use by the restricted population.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
The unregulated availability of Plan B "contraceptives," or rather abortafacients, to the children and grandchildren of taxpayers and voters who oppose the preventing and taking of nascent human life is an egregious insult to moral conscience.