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 : EC1138
Submitter : Ms. Kathleen Bond Date & Time: 10/27/2005 02:10:10
Organization : Ms. Kathleen Bond
Category : Health Professional
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. It is dangerous to be giving an OTC which is a prescription drug product to minors or adults whose health status is unknown. It has already been brought to the public eye that death can result even from a prescription drug.
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.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
Yes. No perscription drug should be given as an OTC.
C. If so, would a rulemaking on this issue help dispet that confusion?
Yes, if the drug is only available as a perscription.
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?
More so than as an OTC.
B. If it could, would it be able to do so as practical matter and, if so, how?
Use of the drug would have to be reported to the FDA.
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?
Absolutely not.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
No circumstances.
GENERAL
GENERAL
Prescription drugs should never be sold as OTCs to anyone let alone minors. This is dangerous to the health and life of any individual.