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 : EC880
Submitter : Ms. Elizabeth Brookbank Date & Time: 10/17/2005 10:10:34
Organization : Ms. Elizabeth Brookbank
Category : Drug Industry
Issue Areas/Comments
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. There are plenty of products that are sold only to adults and not to children, there shouldn't be any more of a problem selling EC this way.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
There is significant confusion regarding the wording of these questions, but the issue itself is clear. EC needs to be available to women over the counter. If the only way this can happen is by only allowing woman ages 16 and older to obtain it OTC, then that will do for now.
C. If so, would a rulemaking on this issue help dispet that confusion?
What would help dispet the confusion is if FDA would make a prompt, clear decision on this simple issue and stop succumbing to political pressure, which should have no place in the decision-making process of FDA.
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. In the same way that that there are enforcable age limits on numerous other products.
B. If it could, would it be able to do so as practical matter and, if so, how?
Yes, all the store/pharmacy, etc. would have to do is ask for identification, the same way they ask for identification to buy other age-restricted products.
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?
Make the packages different if you want, if the cashier/pharmacist is doing his/her job and knows they have to ask for identification to sell the product, then this shouldn't be an issue.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
If there is a failure to ask for identification, then the single package may be inappropriate.
It is high time for FDA to stop dragging its feet on EC. It is safe, it is effective, it will prevent hundreds of thousands of unwanted pregnancies every year, and women have the right to obtain it quickly and easily.