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 : EC402
Submitter : Dr. Patricia Murphy Date & Time: 09/20/2005 04:09:57
Organization : University of Utah
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?
I doubt that a rulemaking would offset the confusion that would result. see below
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?
I doubt that a rulemaking would offset the confusion that would result. see below
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
There is a great deal of confusion as to how this would be implemented, and why it is necessary given that women of all ages can purchase other medications over the counter with worse safety profiles than Plan B.
C. If so, would a rulemaking on this issue help dispet that confusion?
No see below
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?
Who would enforce it? Would you require records be kept of all women requesting the OTC product to see if they were of the right age? This concerns me greatly. It would require checking of age identification for women and in effect would thus limit access to the product for any woman who would have to wait for the ID check. In some pharmacies, only a person over the age of 18 or 21 would be allowed to check the ID. It would create a public awareness of the product the woman is purchasing, thus limiting her confidentiality. This is not done for any other OTC medication (aspirin, NSAIDS, etc.)
B. If it could, would it be able to do so as practical matter and, if so, how?
No. see above