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 : EC1215
Submitter : Ms. Kathryn Dixon Date & Time: 10/27/2005 05:10:02
Organization : Ms. Kathryn Dixon
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 approve, without further delay, the over-the-counter sale of EC, with no prescription required for any age groups.
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?
The FDA should approve, without further delay, the over-the-counter sale of EC, with no prescription required for any age groups.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
The FDA's delay on approving EC has confused what should be a clear-cut issue. The FDA's scientific panel approved the idea, and the FDA should follow their knowledgable counsel and approve over-the-counter sale of EC.
C. If so, would a rulemaking on this issue help dispet that confusion?
A proposed rule with a time consuming comment and review process would only to drag out inevitable final decision on EC - OTC is made. It is unnecessary.
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?
It is the FDA's job to determine the safety and efficacy of a product, not police it's moral implications. Making EC available only to a particular population falls into that trap. The FDA would create an undue burden and intrusion on people's lives by enforcing such a limitation.
B. If it could, would it be able to do so as practical matter and, if so, how?
If it could, it would be incredibly intrusive for potential purchasers of EC and a burden on providers and the government working to enforce such a pointless restriction. In short, it would be a waste of everyone's time.
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?
If EC is made universally available, there is no need for separate packaging.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
none.
GENERAL
GENERAL
The FDA needs to desist in catering to "moral" concerns and do it's job. The scientific advisors made their recommendation, and while the FDA is not required to abide by it, I can see no good reason why they shouldn't in this case. The proposal to restrict access to EC makes no sense, and should cease to be a consideration. EC should be universally available over-the-counter.