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 : EC1035
Submitter : Ms. Karen Landis Date & Time: 10/27/2005 10:10:33
Organization : University of Alaska Anchorage
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?
Yes. REstrictions and regulations regarding medication should not be vague.
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.
C. If so, would a rulemaking on this issue help dispet that confusion?
I would hope so.
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?
Yes.
B. If it could, would it be able to do so as practical matter and, if so, how?
The FDA is already a huge, unweildy bureaucracy. Adding more responsibilities does not seem practical.
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?
No.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
When it would pose a risk to consumer health.
GENERAL
GENERAL
It ought to be the function of the FDA to approve medication when it is beneficial for people to have access to it and to regulate that access only as it is necessary to prevent the medication from causing harm. The mechanics of who should take which medication is a task that belongs to doctors and health care practicioners.