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 : EC907
Submitter : Mr. David Sadowski Date & Time: 10/18/2005 01:10:42
Organization : Mr. David Sadowski
Category : Individual Consumer
Issue Areas/Comments
I request that the decision be a medical one and not one pressured into by lawmakers. My personal opinion is that it shold not be available OTC. To let that strong a drug on the market would be inexcusable. The abuse of it could not be controlled. If allowed to go OTC, I foresee women using it to induce an abortion by overmedicating. The FDA does not want that responsibility. The effects on younger women is also too unknown to proceed. Be cautious. Promote resonsibity so this wouldn't be needed in the first place. Thank you.