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 : EC2068
Submitter : Mr. Alan Cochran Date & Time: 10/31/2005 06:10:24
Organization : Mr. Alan Cochran
Category : Health Professional
Issue Areas/Comments
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC drug product?
In consideration of making "Plan-B" an OTC drug, I am adamantly opposed to such a decision. Both on ethical and professional grounds, this drug shouldn't be marketed to young women as a safe, too convenient means to allow them to casually engage in intercourse. As a Pharmacist, I don't want to be required or even forced to fill abortifacients and would not stock such an OTC med in my Pharmacy. The rush to condone dangerous sexual behavior shouldn't be fixed with a potentially dangerous medication that currently requires a prescription. Thank You!