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 : EC630
Submitter : Miss. Maria Bremberg Date & Time: 10/12/2005 06:10:05
Organization : Miss. Maria Bremberg
Category : Health Professional
Issue Areas/Comments
GENERAL
GENERAL
I think it would exhibit very bad judgement for the FDA to allow any woman to obtain Plan B without having consulted her primary care provider and obtaining a prescription. There is no way to practically control who obtains Plan B if it is made OTC. Even if you tried to card everyone, most minors do not carry identification. Pharmacologically, as this is the same drug as the birth control pill, it is absurd to place a stronger dose OTC and keep the birth control pill prescription only. It would be very dangerous to place Plan B at the fingertips of consumers, it is a resipe for medical errors, overdose, and disaster. A woman could but 2 boxes of Plan B "just in case" and use them simultaneously or twice in a month. A woman using Plan B should be supervised by her primary care provider and not left to her own devices as this could be quite dangerous.