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 : EC635
Submitter : Mr. Leo Paquette, RPh Date & Time: 10/12/2005 06:10:29
Organization : Mr. Leo Paquette, RPh
Category : Health Professional
Issue Areas/Comments
Regarding the proposal to make Plan B available OTC to women over 17, I do not think this should be done. First of all, the moral dimension of the use of this product has apparently not been addressed at all, as far as I can tell. This is morally no different than obtaining an abortion, except that the woman isn't certain at time of using the product whether she is in fact pregnant. It is certain that uncontrolled use of this product will further erode the already greatly diminished sense of personal moral responsibility felt by many young people today.
Secondly, there seems to be no way to prevent a woman who is over 17 from obtaining the product for someone who is under 17. So much for limiting its use to those over 17.
Finally, although I am sure there are a good many other reasons not to approve this change, I would just point out that once again the parents are totally removed from the decision-making process for their 17-and-over dependent daughters, but will be expected to pick up the pieces of their daughters' lives when there is an 'unforseen' problem due to use of this drug.
Please do not make this change of status for this product.
Thank you.