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 : EC437
Submitter : Mrs. Marie Mawn Date & Time: 09/21/2005 08:09:09
Organization : Families for Life
Category : Other Organization
Issue Areas/Comments
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?
It would be very unlikely, given that the responsibility of gatekeeper for an extremely powerful formulation would fall to the cashiers at the local pharmacy, who are not trained for such a huge task.
The Families for Life organization urges the FDA to reject Barr Laboratories application to allow Plan B to be sold over the counter. This formulation contains mega-doses of potentially dangerous medication, exposing women of every age to unnecessary risk in the absence of medical exam or physician oversight. Regions where emergency contraception is sold without a prescription have seen large increases in the number of STD's without decreases in unintended pregnancy, leading us to assume that the product is being misused. Of equal importance, the abortifacient effect of this medication kills a newly formed human embryo. Further promotion of Plan B will simply put women at every stage of life at risk.