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 : EC1837
Submitter : Ms. Margaret Russell Date & Time: 10/31/2005 03:10:36
Organization : Ms. Margaret Russell
Category : Individual Consumer
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?
Please approve OTC sales of emergency contraception.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
The only confusion is why on earth approval for all women, regardless of age, in need of emergency contraception was not granted earlier.
C. If so, would a rulemaking on this issue help dispet that confusion?
The proposed rule only serves to delay what should be swift approval.
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?
Age limitations on alcohol are already in place and to some extent enforceable and enforced. However, by making access to emergency pregnancy prevention unavialable to women of any age who are in current and immediate need is absurd. Studies have shown it to be safe and effective, it is now the FDA's job to make it available.
B. If it could, would it be able to do so as practical matter and, if so, how?
It is neither practical nor desirable to deny contraception based on the age of a woman who is in immediate danger of becomming pregnant when she does not want to be. Requiring proof of age ID for alcohol or tobacco is a minor inconvenience. To determine if one is old enough to not be pregnant is absurdity and cruelty.
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?
Different packaging would seem decidedly unnecessary if the only difference between the products is the age of the recipient. The product, instructions, and use would remain the same. Different packaging would put a false limit on the supply available for each age group. Further, packaging would not be a problem if a prescription was unnecessary and the product availalbe as needed.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
OTC emergency contraception should be widely and easily available to all women in the USA. It has been shown to be safe, effective, and provide protection to those who are most at risk for unwanted pregnancy. There is no value in denying acces to emergency contraception to young women, and there are many health reasons why those young women are best served by preventing pregnancy. Please make emergency contraception available to all women regardless of age, free of restriction, and widely available.