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 : EC2024
Submitter : Ms. Sue Stiles Date & Time: 10/31/2005 05:10:29
Organization : Ms. Sue Stiles
Category : Drug Association
Issue Areas/Comments
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
C. If so, would a rulemaking on this issue help dispet that confusion?
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?
Is the law going to be unjust discrimination?
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?
I think this could become rather confusing & have legal ramifications
due to people being so quick to sue.
I think the emergency contraceptive should be made available to anyone who has a need for it, if they are old enough to have sex they should be able to make their own choices, as to the consequences thereof.