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 : EC1158
Submitter : Ms. Katherine Green Date & Time: 10/27/2005 04:10:41
Organization : Ms. Katherine Green
Category : Individual Consumer
Issue Areas/Comments
GENERAL
GENERAL
I wish to register my support for over-the-counter, non-prescription status for emergency contraception. The FDA's own expert advisory panel recommended 23 to 4 that EC be available OTC without a prescription 2 years ago. EC has been shown to be most effective when taken 24 hours after unprotected sex, and requiring a prescription to obtain it places an undue burden on women, especially poor women and others who may not have quick access to a doctor. Increased availability of EC has been shown to have no effect on women's willingness or desire to engage in sexual intercourse (i.e., it does not "encourage promiscuity" as has sometimes been claimed) and is not equivalent, as has sometimes been argued, to abortion, as it has no effect on fertilized eggs that have already implanted into the uterine lining. The continued delays on this issue by the FDA place women's health in unnecessary jeopardy and must end. EC should be made available over-the-counter and without prescription.