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 : EC231
Submitter : Ms. Jessica Livingston Date & Time: 09/20/2005 02:09:59
Organization : University of Florida
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?
It could be enforced the same way as the sale of alcohol and tobacco is enforced. It should, however, be available for sale to anyone.
B. If it could, would it be able to do so as practical matter and, if so, how?
Yes, it would be a practical matter of simply showing a driver's license or other form of id the same as is used for buying alcohol or tobacco.
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?
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
The morning-after pill is available in 38 other countries over the counter. Women in the U.S. should have access to all available forms of birth control. Why is the FDA ignoring its own scientists to the detriment of women's health? Why is the FDA refusing to listen to the women of this country who have been demanding the morning-after pill over the counter?