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 : EC1967
Submitter : Dr. Christine Hrountas Date & Time: 10/31/2005 04:10:39
Organization : Dr. Christine Hrountas
Category : Health Professional
Issue Areas/Comments
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?
yes
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?
hopefully
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?
yes, require ID. Realistically, Women under 18 would have a driver's license at 16 to 18 years of age depending on the state, but not all people have a license or other ID. School ID does not have birth date and would not be a legitimate or appropriate document.
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?
none
GENERAL
GENERAL
Emergency contraception should be available to every woman who needs it, regardless of age. Requiring a prescription if under 18 years of age is a political not scientific issue. The goal is to prevent unplanned and unwanted pregnancies and avoid abortions. Pregnancy and abortions are of highest risk in women under 18. This subgroup of women are still immature, psychologically, physically and financially.
Emergency contraception is an option that could greatly reduce the number of abortions, give peace of mind to women who have been raped, and assist couples who have experienced contraceptive failures. It is not an abortifacient and we should educate people on its efficacy, availability and use.