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 : EC1058
Submitter : Mrs. Liane Atlas Date & Time: 10/27/2005 10:10:01
Organization : Mrs. Liane Atlas
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?
This is a larger question than that of permitting over-the-counter sale of Plan B and should be left for decision after the URGENT decision is made on Plan B. If FDA has operated without rulemaking up to now, that decision can certainly wait.
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?
See comment above.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
See comment above. This is all a stalling tactic.
C. If so, would a rulemaking on this issue help dispet that confusion?
See above comments.
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?
See above comments.
B. If it could, would it be able to do so as practical matter and, if so, how?
See above comments.
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?
See above comments.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
See above comments.
GENERAL
GENERAL
I can't believe that the FDA has so little integrity that it is continuing to stall a decision which is supported by almost all of the medical community and many other countries. Plan B is urgently needed to be available over the counter and the FDA dosn't need answers to all the above questions to approve it. While the later questions would be avoided if you adopted the better policy of not putting in any age limits; if you insist on the latter, just go ahead and approve the drug on that basis and you'll get answers to your questions soon enough.
2005N-0345-EC1058-Attach-1.PDF
2005N-0345-EC1058-Attach-1.PDF
2005N-0345-EC1058-Attach-1.PDF
2005N-0345-EC1058-Attach-1.PDF
2005N-0345-EC1058-Attach-1.PDF
2005N-0345-EC1058-Attach-1.PDF
2005N-0345-EC1058-Attach-1.PDF
2005N-0345-EC1058-Attach-1.PDF
2005N-0345-EC1058-Attach-1.PDF