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 : EC954
Submitter : Mr. Allan Ackerman Date & Time: 10/27/2005 08:10:28
Organization : Mr. Allan Ackerman
Category : Individual Consumer
Issue Areas/Comments
GENERAL
GENERAL
I have serious concerns regarding the continued push to make EC available OTC. First, there exists several serious side effects to women when choosing to use this particular product and this alone should invite reservation for changing the status quo. Second, one of the means by which EC works it to deny the human embryo the ability to implant in the uterus (a point conveniently omitted by many proponents of OTC access). This last point is what gravely concerns me. As it stands there is no realistic method by which we can monitor the number of human beings who have been denied the right to life using this chemical. How much less so will we be able to monitor this trend should EC be made OTC. As a dedicated scientist as well as a concerned United States citizen, I am asking that the FDA not only critically review Barr Laboratory's application for OTC access to MAP, but more importantly to review whether this dangerous agent should be on the US market at all. At best the FDA would be wise to reject any attempt to make EC available without a prescription. The consequences of such access are largely unknown and potentially destructive.