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 : EC1037
Submitter : Ms. Noel Wharton Date & Time: 10/27/2005 10:10:06
Organization : Ms. Noel Wharton
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?
Yes, but perscription drugs should be in higher concentrations per dose. The drugs should be available without a perscription in order to be accessible to a greater amount of people.
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?
Yes, not all active ingredients are appropriate for sale to the general public. Determining which drugs to should be available in OTC and perscription forms should be regulated and monitored.
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, this would encourage people to seek other means of obtaining that drug from another subpopulation.
B. If it could, would it be able to do so as practical matter and, if so, how?
No
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?
Yes, provided that the drug are identical
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
No, they would need different packaging to lessen the confusion between the two products if they are of different concentrations in each dose.