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 : EC948
Submitter : Dr. Ruth Krauss Date & Time: 10/27/2005 08:10:04
Organization : Group Health Cooperative of Puget Sound
Category : Health Professional
Issue Areas/Comments
I am interested only in the safety and efficiency of this product. I have been been prescribing "morning after treatment" for many years in its various forms. The safety data for Plan B and most of its predecessors has been exemplary. Plan B is as effective and has fewer side effects than previous formulations. The public health benefits of making Plan B available OTC are obvious. Anyone who wishes to decrease unwanted pregnancies and the need for abortion should be fully in favor of making this medication available without prescription.