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 : EC903
Submitter : Mrs. Margaret Kopp Date & Time: 10/18/2005 01:10:58
Organization : Mrs. Margaret Kopp
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?

No. The FDA is so thoroughly biased and under the influence of politics that any rule that it makes at this time will be in the interest of politics, and not in the interest of good medicine, nor in the interest of the public sector.
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?

This comment section appears to be identical to the one above it, except that there is a grammar error in this one. They are both identified as the "1. A." comment, with very similar wording.

"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?"

and

"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?"


Please note that in the second "1. A." comment, in the following passage "when an active ingredient can be simultaneously market in both a prescription drug product...", the appropriate verb should be "marketed", not "market".

B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?

No. It is very clear that the FDA is making the interpretation that is preferred by White House, without regard to actual safety and efficacy of the drug in question. I am not at all confused. I am, however, deeply offended by the actions of the FDA, in hijacking this drug as part of a political
agenda.
C. If so, would a rulemaking on this issue help dispet that confusion?

If you are sensing confusion, it is probably due to the spelling errors on your website where comments can be submitted. To help clear up the confusion, let me suggest to you that "dispel" is spelled d-i-s-p-e-l, NOT d-i-s-p-e-t.
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?

No. The subpopulation in question would simply find a person who meets the preferred criteria to obtain the OTC product for them.
B. If it could, would it be able to do so as practical matter and, if so, how?

Yes. A simple solution to this problem would be to require a prescription for young women age 16 and under. They will then get an older friend to buy the drug for them, and everyone will be happy, sort of. Young women are used to having their rights trampled, so they will not realize the extent to which they have been denied their rights until they are much older.

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?

It depends on whether the written patient instructions accompanying the package could be made clear and un-ambiguous under those circumstances.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?

If there were patient instructions that would apply to prescription use that do not apply to OTC use, and this could not be made clear in the patient instructions, then it would be inappropriate to sell the item in the same packaging.
GENERAL
GENERAL

Many OTC drugs are sold with clearly labelled instructions "under age two, ask your doctor", or "under age 12 ask your doctor". I see no reason why this OTC drug could not be labelled in a similar fashion.

We should consider whether the prescription requirement for this drug should be removed entirely. If it can be safely sold without a prescription, then clearly IT CAN SAFELY BE SOLD WITHOUT A PRESCRIPTION.

Removing the prescription requirement for the drug would eliminate what appears to be a major source of confusion.