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 : EC898
Submitter : Ms. margaret bonaparte Date & Time: 10/17/2005 11:10:21
Organization : Ms. margaret bonaparte
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?
The FDA should approve this product for over the counter use for anyone and stop bowing to religious interests. Any female capable of reproduction should be able to access a safe form of contraception without anyone's approval. The FDA has become a puppet of the current christian conservative administration rather than the public service agency it is supposed to be. You should be ashamed of yourselves.