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 : EC2113
Submitter : Ms. Karen Howe Fernandez Date & Time: 10/31/2005 06:10:37
Organization : Ms. Karen Howe Fernandez
Category : Individual Consumer
Issue Areas/Comments
Please note my support for over-the-counter (OTC), non-prescription status for emergency contraception (EC). I oppose any further delay in permitting EC to be sold over the counter without a prescription.
EC is most effective (95%) if taken within 24 hours after unprotected sexual intercourse - when a condom breaks, birth control is not used, or if a sexual assault occurs. Forcing women to get a prescription before they can obtain EC is an unwise and unnecessary burden on all women, especially poor women who may not have access to a physician. Moreover, requiring a physician's prescription increases the total cost of EC dramatically.
Your expert advisory panel recommended with a 23-4 vote that EC be made available over the counter without prescription almost two years ago. Do not allow politics to interfere with women's health. Make EC available OTC. Thank you. Karen Howe Fernandez, Bloomington, Indiana