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 : EC944
Submitter : Mrs. Suzanne Castelda Date & Time: 10/27/2005 08:10:41
Organization : Okanogan CareNet
Category : Individual Consumer
Issue Areas/Comments
As an RN and as a concerned member of a crisis pregnancy center and as a lifelong citizen of Washington state (and in spite of Patty Murry's position) I believe that "Plan B" for over the counter use is a "very bad" plan. It would make this drug available to those who are not mature enough to make those decisions alone. There have proven to be side effects to this drug that need to be more thoroughly studied to be considered safe for anyone, especially minors. The dangers shown by this drug are such that they need to be evaluated very carefully before their use by women. This drug is not to be used as a quick fix for poor decisions, but if it was sitting on the pharmacy shelf, I feel that is what would happen.