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 : EC613
Submitter : Miss. Katherine Clyde Date & Time: 10/12/2005 06:10:35
Organization : self
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?
You should consider the facts about the safety of Plan B and the other forms of the Morning After Pill. Do not consider evidence which proceeds from groups with economic advantage tied to their reports.
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding when an active ingredient can be simultaneously market in both a prescription drug product and an OTC drug product?
The Morning After Pill Plan B cannot safely be administered over the counter or prevent women under 16 from obtaining it.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
MAP is linked to disease and infection and will cause a rise in surgical abortion and other complications.
GENERAL
GENERAL
Please reconsider the safety of this drug and the serious consequences to the women who take it.