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 : EC717
Submitter : Mr. Joseph Gorini Date & Time: 10/12/2005 06:10:20
Organization : Mr. Joseph Gorini
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?
First, please consider whether or not the FDA should be answering this question with regard to Plan B. Plan B should not be considered to fall under the FDA's concern for 'health and safety.' See General Comment.
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?
First, please consider whether or not the FDA should be answering this question with regard to Plan B. Plan B should not be considered to fall under the FDA's concern for 'health and safety.' See General Comment.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
If the FDA applies section 503(b) it would ceate confusion by seeming to accept Plan B as falling under FDA's concern for 'health and safety.' See General Comment.
C. If so, would a rulemaking on this issue help dispet that confusion?
Rule making on this issue with regard to Plan B would confuse the proper understanding of 'health and safety.' Plan B should not be considered to fall under the FDA's concern for 'health and safety.' See General Comment.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a matter of law?
What is the FDA's experience with other abortifacients?
B. If it could, would it be able to do so as practical matter and, if so, how?
No!
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may the different products be legally sold in the same package?
I would hope not!
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
Always.
GENERAL
GENERAL
In and unusual exchange this week in the US Congress, among the highest ranking UN officials admitted that the term "reproductive health" does not include abortion, at least in the context of the recently decided Millennium

Summit Declaration. The exchange came during a hearing of the US House Committee on International Relations when Congressman Chris Smith questioned Mark Malloch Brown, senior adviser to UN Secretary General Kofi Annan. Smith asked Brown three times if "reproductive health" included access to abortion. Brown finally admitted that it did not.