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 : EC2016
Submitter : Dr. David Sacks Date & Time: 10/31/2005 05:10:18
Organization : Kaiser Foundation Hospital
Category : Health Professional
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?
I think that this proposal serves no useful purpose, at least from a scientific and a practical viewpoint. The ingredients in the emergency contraceptive, taken as directed (ie levonorgestrel 0.75 mg in two doses 12 hours apart) have not been shown to cause any damage to human females capable of reproduction of any age. I would suggest making it an OTC product for all who have need for it.
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?
Did you mean "marketed" rather than "market"? If so, my response is the same as above.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
The confusion on my part is trying to understand the line of reasoning in dichotomizing the OTC availability of this drug.
C. If so, would a rulemaking on this issue help dispet that confusion?
No.
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?
Not having a background in law, I can only conjecture that this limitation would likely be as enforceable as were those limitations imposed by the 18th Amendment to the Federal Constitution.
B. If it could, would it be able to do so as practical matter and, if so, how?
I doubt that it would be enforceable as a practical matter. Laws are enforceable only when they have public support. Those who have need of a safe
drug will find a way to obtain it.
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?
Again, this is a legal matter, on which I feel unqualified to comment. From a practical viewpoint, assuming it is legal to market the same active ingredient in both a prescription and OTC product, the packaging becomes irrelevant.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
As with any other drug, it would be inappropriate to sell it for any purpose other than that for which it is intended.