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 : EC1970
Submitter : Mr. Joshua Crousey Date & Time: 10/31/2005 04:10:25
Organization : Pittsburgh
Category : Academia
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.
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, as a law student I can say that there would be significant limitations. This would be regarded as creating a 'class' of people. This always has problems associated with it.
B. If it could, would it be able to do so as practical matter and, if so, how?
Here's my biggest problem. If it's available easily, what's going to stop an older person from buying it when he finds out that he got an underage girl pregnant? Right now, we have the prescription process in place and serious consequences for trying to avoid using a prescription. This is a drug that we just might want people to have to get a prescription.

How would you be able to tell who should or shouldn't receive it? Are you going to check ids at the store? How can we be sure that older people won't give it to younger people?