2005N-0345
FDA Comment Number : EC1508
Submitter : Ms. Michelle Oja Date & Time: 10/31/2005 09:10:53
Organization : Ms. Michelle Oja
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.
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?
No.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
Yes.
C. If so, would a rulemaking on this issue help dispet that confusion?
May be, but more words may just be more to interprete.
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?
No.
B. If it could, would it be able to do so as practical matter and, if so, how?
Probably, through education of the pharmacists.
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?
Yes.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
There would be no such circumstances.
GENERAL
GENERAL
This latest tactic to further delay making the correct decision to approve universal, over-the-counter availability of emergency contraception is an insult to all women. It further discredits the Food and Drug Administration as a responsible, professional science-based organization. The proposal to restrict access of EC ? OTC to women 16 and under makes no rational or practical or medical scientific sense. Determination of the safety and effectiveness of emergency contraception, with the added public health value of preventing unintended pregnancies ? no matter the age of the woman - should be primary criteria for making this decision. What could possibly be the public health value in restricting access to adolescents ill- prepared ? emotionally and physically ? to carry a pregnancy to term? We agree and the data indicate that access to emergency contraception will not encourage promiscuity or that EC would lessen the routine use of contraception.

Some 39 nations have made emergency contraception available without prescription and 8 states in the U.S. have now adopted a process to streamline access of emergency contraception. The FDA's delay and ill-advised intention to restrict access to women 16 and younger is unacceptable and intolerable. Please make the decision to allow emergency contraception available to all women, all ages, and no restrictions.