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 : EC1099
Submitter : Dr. Diana Currie Date & Time: 10/27/2005 12:10:59
Organization : Kaiser Permanente
Category : Health Professional
Issue Areas/Comments
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?
Plan B is completely harmless - THERE ARE NO MEDICAL CONTRAINICATIONS AT ALL. There is no reason to restrict it to any age menstruating female. Young teens, older teens and adults all have no medical contraindications - IT IS COMPLETELY SAFE!!!!!
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
I think it is on purpose just to prevent the FDA from making plan B OTC - LIKE IT IS IN MOST EUROPEAN NATIONS!!!!
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?
probably, just the way it is done with cigarettes and alcohol. - both of which are far more dangerous and deadly that Plan B.
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?