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 : EC428
Submitter : Dr. Anne Rizzo Date & Time: 09/20/2005 04:09:14
Organization : INOVA Fairfax 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?
We already have products with the same active ingredients OTC. Usually the dosages are just different. For Plan B the dosage is similar to that in birth control pills
1.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
Yes in the general populace. It appears that the FDA is bowing to political activism versus establishing policy pharmacologicaly supported by research data.
C. If so, would a rulemaking on this issue help dispet that confusion?
Yes with an explanation and interpretation of the rule
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?
Yes
B. If it could, would it be able to do so as practical matter and, if so, how?
Have it marketed through health care professionals or at health care facilities to help with its dissemination. This will limit access and therefore overall sales, but it is possible.
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?
No, I think the packaging should be able to differentiate the product.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
Yes, it would cause confusion on the part of the consumer
GENERAL
GENERAL
I would urge you to approve Plan B for widespread use in the United States. It is a safe and non-surgical option that should be easily available to women.