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 : EC729
Submitter : Mrs. M. Brown Date & Time: 10/13/2005 08:10:11
Organization : Mrs. M. Brown
Category : Individual Consumer
Issue Areas/Comments
1.
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?
if it was by prescription only there would be no issue; if women are responsible enough to have sex then they should be responsible enough to be prepared ahead of time and also be seeing their doctors on a regular basis. there should be no need to have it over the counter at all, thus safeguarding all women esp. our youth
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?
Minors are able to buy cigarettes in spite of the age restriction, so this seems to be no difference. Also many times the male is older and will purchase it for the younger girl. Young people are just starting to emotionally mature and this puts them at an unfair advantage. They need proper counsel.
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?
No
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
Full disclosure to all side effects need to be given in every circumstance and I feel that a doctor should be giving that information out to whoever is to be using the product.
GENERAL
GENERAL
the more contraception is available the higher incident of SIDS and of unplanned pregnancies.