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 : EC1030
Submitter : Ms. Maureen Gombas Date & Time: 10/27/2005 10:10:36
Organization : Ms. Maureen Gombas
Category : Individual Consumer
Issue Areas/Comments
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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 long as it meets FDA safety standards.
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?
Yes. As long as it meets FDA safety standards.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
Yes; most of the confusion stems from the resignation of the FDA Director of Women's Health. Paraphrasing her comments, her resignation was necessary due to the FDA's stall on a rulemaking regarding Plan B--why would this happen if it was medically proven to be safe as an OTC drug?
C. If so, would a rulemaking on this issue help dispet that confusion?
Yes.
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B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
When the targeted consumers, in this case women, are not (made) aware of the situation. In other words, in order to act lawfully in regard to identical packaging, if a women goes to a doctor to obtain a prescription for Plan B, she should be told that she does not need a prescription.