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 : EC1086
Submitter : Ms. Michelle McCormick Date & Time: 10/27/2005 12:10:41
Organization : Ms. Michelle McCormick
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?
It makes very little sense, if the drug is nessisary to the welfare of thousands of American women, to limit and restrict the access to said drug. The FDA needs to base rules on the health & well being of Americans, not politically motivated "interpretations" of sections and codes.
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?
See above
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
Definitly, because I am certianly confused.
C. If so, would a rulemaking on this issue help dispet that confusion?
Maybe so, but more than likely it will restrict the process of issuing drugs even further.
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?
Sure. In California, the sale of over the counter sinus medication (used in the production of methanphetimines) is restricted to people with an ID stating that they are over 18 years of age. This seems to be working.
B. If it could, would it be able to do so as practical matter and, if so, how?
By restricting access based on IDs and age, or the presence of an adult, unless prescribed by a doctor.
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, because it would be nessisary to ease confusion over the two options.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
I am not sure if I can think of a situation.