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 : EC1981
Submitter : Miss. Abigail Rubsam Date & Time: 10/31/2005 05:10:33
Organization : Miss. Abigail Rubsam
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?
The FDA should immediately approve over the counter sale of emergency contraception to women of every age. This is extremely important because as an emergency contraceptive it needs to be taken quickly, and as a potentially sensitive issue, especially for young women, the privacy given by an OTC drug is necessary.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
Plan B is safe and effective. Age should not have been brought into the equation. The product would be utilized mainly by women over 16, and their access should not be limited to it because of confussion over age limits.
C. If so, would a rulemaking on this issue help dispet that confusion?
No. OTC emergency contraceptives should be approved now.
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?
Women of all ages get pregnant-shouldn't the means to abort pregancy be available to any woman with an unwanted pregnancy?
B. If it could, would it be able to do so as practical matter and, if so, how?
Again, it is possible and often happens that a 13 or 14 year old is impreganted. Contraception should be available to women of all ages. It is not the place of the FDA to decide which age groups may take a product, unless that product is proven unsafe for a certain age.
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?
It would be fine to use the same package, as long as non perscription emergency contraception is available to everyone.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
Please, help prevent unwanted pregancies, and late term abortions. Make over the counter emergency contraception available to all women.