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 : EC945
Submitter : Mr. Zachary Galiyas Date & Time: 10/27/2005 08:10:54
Organization : Mr. Zachary Galiyas
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?
There is no way the FDA would be able to enforce such a limitation. Most pro-choice sellers would give the drug to underage women without evn asking what age she is. Even if a child couldn't buy the drug in person, she could just get an older sister or friend to do so.
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?
When I think of OTC drugs, I think of taking a tylenol to ease the pain of a headache or upset stomach. Abortion is a much graver matter. Due to the controversial nature of the action, it ought to be heavily regulated. Having it the drug available by prescription is bad enough. It is ridiculous to make buying an abortion-inducive drug as easy as buying food, clothing, books, etc.