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 : EC887
Submitter : Mrs. Kristi Hixson Date & Time: 10/17/2005 11:10:01
Organization : Mrs. Kristi Hixson
Category : Individual Consumer
Issue Areas/Comments
GENERAL
GENERAL
Please do not allow the morning after pill to become available over the counter. Having this medication so readily accessible will promote less responsible sexual behavior in our younger and/or less informed population, inevitably leading to a broader spectrum of health hazards for many people. In addition, the person obtaining this medication by prescription would have both a physician and a pharmacist giving instructions, as well as the ability to ask questions regarding the medication and use of such, whereas the average person buying medication over the counter usually just skims through written directions, thereby becoming less informed about it than the prescription user. The age restriction would also cause problems, as there will be no agency responsible for enforcing (either literally or practically) such a restriction, and our resourceful young people will find a way around this in order to obtain this drug. Thank-you for your time and consideration in this matter.
Sincerely,
Kristi Hixson