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 : EC737
Submitter : Mr. Stan Young Date & Time: 10/13/2005 08:10:14
Organization : Mr. Stan Young
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. Such a rulemaking is not needed.
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?
No.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
Only on the part of the FDA.
C. If so, would a rulemaking on this issue help dispet that confusion?
The FDA should only create both OTC and prescription versions of the medications when there is MEDICAL need for such versions. There is no other reason to do so. Morality is NOT the domain of the FDA.
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?
The equal protection clauses of the law offer a high bar to this. Any such limitation is sure to face immediate and successful challenge on consitutional grounds.
B. If it could, would it be able to do so as practical matter and, if so, how?
Absolutely not.

Take Plan B, for example. If the drug is sold over the counter to all, a pregnant 17 year old (or 15 year old, for that matter) would be able to buy it in a store, and be able to ask a pharmacist questions including drug interactions, contraindications, and whatever other questions might come up.

If it becomes a prescription item for those under 18, consider the most likely course of action - go to a doctor, get the prescription, go to the pharmacy and get it - or just drop by the store with an older friend, a fake id, or perhaps obtain it mail order. They'll have no guidance beyond what's on the package - and they probably will read nothing beyond how many to take and when.

You'll find girls getting these when they can, just to have it when they might need it - but the drug may go out of date before there is need for it.

This is exactly what we don't want - drugs at their least effective, taken with the least information available. That's not desireable medically, it is not desirable socially. It's bad policy, all around.
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?
I believe it is moot, but there's no reason why they couldn't both be sold in the OTC package.
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
The FDA should move swiftly to end this enquiry, approve Plan B for OTC use as your advisors have so strongly recommended, and allow the manufacturer to get it to market. You should also apologize to the company for the additional costs it incurred during this unwarranted delay, and apologise to the American Taxpayers for badly performing your oversight duties. Failing marks all around.