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 : EC679
Submitter : Mrs. Debra Vinnedge Date & Time: 10/12/2005 06:10:27
Organization : Children of God for Life
Category : Consumer Group
Issue Areas/Comments
GENERAL
GENERAL
The FDA's job is to ensure product safety. Plan B is not safe by any means and should not be sold by prescription, much less OTC. Nevertheless, if the use of this drug is not closely monitored by a physician unsuspecting users will most certainly die, including minors who will have easy access to the drug.