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 : EC813
Submitter : Ms. Patricia Wagner Date & Time: 10/13/2005 10:10:29
Organization : Ms. Patricia Wagner
Category : Health Professional
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?
If an active ingredient is marketed in both prescription and OTC forms the packaging and advertising should be clearly different. Assuming that people with no medical training can differentiate carefully nuanced differences invites an increase in drug induced adverse effects that will eventually lead to a distrust in the pharmaceutical industry by the general population.
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?
The FDA should issue an interpretation of section 503(b) that requires that when drugs are simultaneously marketed as both prescription and OTC their packaging and advertising must be so dissimular that the ordinary customer will identify them as two different products.
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?
Over the last several decades we have had laws forbidding the purchase of tobacco and alcohol by those under age. It has been very difficult to enforce and is frequently circumvented by simply having an older friend or acquaintance make the purchase. As it has become increasingly common for adult men to seek out minor females as sex partners, how will they be prevented from purchasing OTCs and using coercion to convince their "girlfriends" to use them or even slipping them into their food or drink without their knowledge?

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?
It would seem to be an invitation for lawsuits against pharmaceutical manufacturers.