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 : EC252
Submitter : Ms. Margaret Hrinya Date & Time: 09/20/2005 02:09:12
Organization : Falk Pharmacy
Category : Health Professional
Issue Areas/Comments
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?
FDA should move this product to otc status immediately. This would be a good product to set up a new category of pharmacist dispensed otc products. It would then be up to the pharmacist to determine that the patient is over 17, or to call the patient's physician if the patient is under 17. Politics has already played too great a part in this whole debate and should be halted immediately.

One sure way to reduce the number of abortions is to offer emergency contraception as an alternative. Religion should have no place whatsover in making these decisions.

Cigarettes are already sold only to those above a certain age, and they're far more dangerous than is the Plan B product.

I am speaking only for myself and not for my employer. Enough is enough. Decisions need to be made on a medical basis only.

There is no valid reason why you can't have both a prescription product and an otc product with the same active ingredient strength. Please follow the recommendations of your advisory committe..
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, depending on the drug. This is a product that should be available to any woman who needs it.
When you sell other otcs in lower strengths than the prescription product, one doesn't have to be a genius to figure out that you just have to take more pills of the lower strength in order to get the prescription strength. This happens on a routine basis. Patients will take 2 or more Ibuprofen, for example, rather than have to go to a physician for a prescription. Prilosec is already marketed in a 20 mg strength otc which is the same strength as the prescription product.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
I'm not sure that there is any confusion, but rather a matter of FDA trying to pacify a religious constituency that has nothing to do with medicine or science. We can not have medical decisions being decided by religious groups or we will have anarchy in medicine.
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?
In reality, no. You could do it, possibly, by restricting the sale of the product to persons younger than 17 to a pharmacist. On the other hand, a pregnancy in a 15 year old is most likely more apt to be dangerous than taking emergency contraception.
B. If it could, would it be able to do so as practical matter and, if so, how?
Pharmacist only category of otc product.
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 think so, although it would make things easier if there was some way to distinguish the packages. Something like is currently being done with Prilosec otc where the letters otc are in large print on the package.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
I'm not sure it would be inappropriate. HOwever, it would be much easier to monitor if there was a differentiation in how the package looked (e.g. different color, different lettering, otc in big letters on the otc package, etc)
Pleae end this charade and approve the product for otc sale. Women deserve to have this product available if they need it.