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 : EC1388
Submitter : Mrs. Gladys Clifton Date & Time: 10/28/2005 03:10:16
Organization : Mrs. Gladys Clifton
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?
NO. There is no valid reason to delay approval of OTC emergency contraception. Two years ago,FDA received data from review committees which deemed EC safa and effective. Nor is there any medical scientific basis for age restrictions. Do not stonewall for political reasons.
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?
There is no valid reason to use rulemaking delaying tactics on such an obviously silly issue. The safety and effectiveness of the OTC products studied make it unnecessary to separate prescription use from OTC access.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
The FDA's attempt to limit access to OTC by age makes no sense. Only approval of access on demand for all women of th safe and effective emergency contraception available makes sense. The FDA should stop trying to create confusion.
C. If so, would a rulemaking on this issue help dispet that confusion?
Certainlhy not. This delaying tactic is unacceptable!
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?
The FDA has no business attempting to enforce such burdensome and privacy-invasiive restrictions--and it's difficult to imagine how to do so. Your job is to stick to safety and effectiveness issues and not support any group's moral agenda.
B. If it could, would it be able to do so as practical matter and, if so, how?
NO--see preceding comment.
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?

Certainly.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
There are no circustances where it would be inappropriate.
GENERAL
GENERAL
The proposal to restrict access to EC-OTC is a disgraceto the FDA as a responsible, professional, science-based organization. Further delaying approval to such access is an insult to all women. 39 nations provide this service.