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 : EC47
Submitter : Dr. Dennis Clason Date & Time: 09/01/2005 04:09:55
Organization : New Mexico State University
Category : Academia
Issue Areas/Comments
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?
It seems rather clear that both State and Federal bodies regulate and enforce product restrictions to particular subpopulations. The legal age for alcohol consumption is 21 years in all 50 states, and this age limit is enforced by both the various States and by Federal agencies (e.g., Department of Defense). Many States have laws and regulations which control the distribution of tobacco products to those over an age limit, and they are able to enforce their laws and regulations. Other substances controlled in similar ways include inhalants (toluene-containing glues and aerosols) and spray paints.

Clearly, if it is permissible for State and Federal agencies to restrict distribution of certain compounds by age, it is both permissible and possible for the FDA to do so.
B. If it could, would it be able to do so as practical matter and, if so, how?
Of course it is. Age limits can be enforced for new drugs in the same way they are enforced for casually used drugs like nicotine and ethanol. Spot check purchase attempts by individuals who appear to be underage and have an underage ID would suffice to control distribution. The FDA can set appropriate fines and penalties for violation of the distribution rules it sets up.
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?
If the indications were different for the OTC and prescription products, I would expect that different packaging would be required and reasonable.

If the indications are the same for the OTC and prescription product, then I think that differentiated packaging is silly.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
See above.
This is without a doubt one of the silliest and most blatantly political exercises the FDA has ever engaged in. The political appointees in the Agency really ought to quit playing footsie and make a decision on the Barr application -- approve it, or disapprove it, but follow your own rules regarding applications.