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 : EC1112
Submitter : Dr. Jason Tompkins Date & Time: 10/27/2005 02:10:49
Organization : Dr. Jason Tompkins
Category : Health Professional
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?
No. Currently, most new tobacco users are younger than 18 years old, yet they manage to get cigarettes somehow.
B. If it could, would it be able to do so as practical matter and, if so, how?
No, see above!
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?
No, the package should be different so as to clarify in the consumer's mind if the drug is given in a monitored manner or if they are taking it at their own risk entirely.
Women younger than 17 years old will be able to get emergency contraception quite easily if it is marketed and sold "only" to women over 17. This is a serious safety issue since women under 17 may be at risk of serious consequences from a large dose of hormones while they are still developing. The safety for all ages that will actually in practice use the medicine must be established before it can be marketed.