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 : EC1959
Submitter : Ms. ANN GLADON Date & Time: 10/31/2005 04:10:36
Organization : Ms. ANN GLADON
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. That is unnecessary. The decision should be made immediately to allow emergency contraception to be sold over-the-counter and without any other restrictions such as age.
1.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
No. I see very clearly what is going on.
C. If so, would a rulemaking on this issue help dispet that confusion?
No. That 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?
That is irrelevant. The decision by the FDA to allow emergency contraception to be sold over-the-counter and without any other restrictions such as age invalidates this question.
B. If it could, would it be able to do so as practical matter and, if so, how?
That is irrelevant. The decision by the FDA to allow emergency contraception to be sold over-the-counter and without any other restrictions such as age invalidates this question.
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?
That is irrelevant. The decision by the FDA to allow emergency contraception to be sold over-the-counter and without any other restrictions such as age invalidates this question.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
That is irrelevant. The decision by the FDA to allow emergency contraception to be sold over-the-counter and without any other restrictions such as age invalidates this question.
GENERAL
GENERAL
This line of questioning on legal jargon is pedantic & unnecessary, and it seems it is intended to confuse and delay action. OTC access to emergency contraception without subgroup limitations is a clear-cut decision, and follows the recommendations of the majority of respected medical professional associations as well as relevant precedents of policy set & followed by the FDA itself. Instigating this side-bar issue is an imposition of morality & politics on a simple issue of public health and safety; by doing that, the FDA discredits itself and forces the public to question the FDA's competency with the purpose and authority it has been given. Please put the focus back on public health and safety and allow unlimited OTC access to emergency contraception.