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 : EC1021
Submitter : Miss. Kathleen Salmon Date & Time: 10/27/2005 10:10:50
Organization : Miss. Kathleen Salmon
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 am unsure who enforces the law that cigarettes cannot be sold to minors, however those same enforcers could be used to sell OCT products to subpopulations. Having drug stores card people to buy OCT drugs would be no different than having convience stores card people buying cigarettes.
B. If it could, would it be able to do so as practical matter and, if so, how?
It could be done in a pragmatic fashion; simploy by carding. The OCT products should be kept behind the counter.
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?
This is a strange question. Why would you sell two products in the same package? If the active ingrediant is the same, why is one a prescription and one an OCT? I think it is viable, and has happened with many products, that prescription drugs become OCT.
I support Emergency Contraception being given an OCT status. I believe that the FDA should do all within its power to prevent unwanted pregnancies as best it can. Women need to have the quickest access to this drug that they can, taken within 24 hours it is the most effective. It needs to be OCT because many women cannot fit going to their doctor and getting a perscription into their schedule; for others going to the doctor to get a perscription may cost more money than they have to spare; some women (like myself) are too embaressed to tell their doctors to reveal their sex life and hesitate to ask for EC perscription--make EC over the counter to reduce unwanted pregnancies.