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 : EC1006
Submitter : Ms. Karen Mak Date & Time: 10/27/2005 09:10:50
Organization : Ms. Karen Mak
Category : Health Professional
Issue Areas/Comments
I recommend that emergency contraceptive pills (ECPs) be available over the counter. U.S. couples are not doing very well planning on when they do and do not want to get pregnant. They are not using contraceptives as effectively as they could. The U.S. has very high rates of unintended pregnancy (approximately 50% of pregnancies in the U.S. are unintended). Having a birth control method, like ECPs, available without a prescription in local drug stores will significantly reduce unintended pregnancy, will reduce domestic violence, will reduce abuse of unwanted children, will reduce the number of abortions in the U.S., and much more. When women and men have more control over their fertility, they will have wanted and loved children, and we will have a healthier society. Thank you for letting me comment. Karen Mak, M.P.H., B.S.N., N.P.