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 : EC921
Submitter : Ms. Jennifer Aengst Date & Time: 10/27/2005 08:10:59
Organization : Ms. Jennifer Aengst
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?
The FDA should determine that product can be both sold as a prescription and OTC. Even though neither the FDA nor the pharmacies are able to regulate whether the consumer is within the age category that the drug is available for, the FDA's responsibility in this case is just to make recommendations not necessarily to enforce them. The individual consumer still has rights.
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, the FDA should codify its interpretation of this act, so that it can address the numerous cases of drugs ingredients that are present in both prescriptions and OTC sales.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
Yes.
C. If so, would a rulemaking on this issue help dispet that confusion?
Yes it would but rulemaking needs to be flexible enough so that it can accomodate particular states...certain states are more progressive than others, in terms of letting consumers determine whether they can have access to medicine, that remains controversial in other states.
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 I think that's an inappropriate use of the FDA's power. Targetting a particular subpopulation is discriminatory...either the medicine is available OTC to everyone or it's not. It's questionnable that the FDA would want to determine which population can have access or not. Either it is available or not...education and warnings can certainly be there, recommendations are appreciated, but if something is going to be available OTC, that means that the FDA has to let go of any sort of control of who buys it.
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'm not sure about that...