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 : EC2110
Submitter : Mr. William Brown Date & Time: 10/31/2005 06:10:41
Organization : Mr. William Brown
Category : Individual Consumer
Issue Areas/Comments
1
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?
Yes, as needed to permit OTC sales of emergency contraception products.
GENERAL
GENERAL
Products of this type need to be made available to the general public as soon as possible without prescription, as a means of promoting individual choice in reproductive matters. The goal of the opposition to these products, like most opposition to abortion, is not on "moral" grounds -- it is simply to *prevent* individual choice.