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 : EC564
Submitter : Dr. Patrick Sullivan Date & Time: 10/12/2005 06:10:11
Organization : Dr. Patrick Sullivan
Category : Academia
Issue Areas/Comments
GENERAL
GENERAL
Plan B contraception is far too complicated to be sold OTC. It is not currently possible to ensure that girls under the age of 16 do not have access to Plan B. At a time when the FDA is facing increasing scrutiny regarding the public health safety of their decisions, it is imperative that the FDA NOT allow the sale of Plan B contraception OTC.