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 : EC365
Submitter : Dr. Angela Deneris Date & Time: 09/20/2005 04:09:28
Organization : University of Utah
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?
YES!!! We need to make this process much more simple and bring these medications to the American public sooner.
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!!! This is a safe medication which will lower the abortion and unplanned pregnancy rate in this country. This medication has extensive study and has very few side effects.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
YES! I think the public and providers are very confused about the process and the length of time it takes to make a decision.
C. If so, would a rulemaking on this issue help dispet that confusion?
I would think so.
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! We do now with tobacco and alcohol. I see no reason that a pharmacist couldn't ask for ID. They do so now with Schedule I and II medications.
B. If it could, would it be able to do so as practical matter and, if so, how?
YES!!! This would not increase the amount of time or money in asking for ID.
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?
YES! I see no reason for different packaging.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
NONE
GENERAL
GENERAL
I feel this product should be available to every woman needing contraception, regardless of age. I believe we make it too difficult for people to get this product, which then needlessly subjects women to unwanted pregnancy. This is tragic. Too many lives are affected. Too many abortions happen that could be provented. Please pass this medication on to be OTC to EVERYBODY!