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 : EC2137
Submitter : Dr. Lucienne Bouvier Date & Time: 10/31/2005 06:10:02
Organization : Dr. Lucienne Bouvier
Category : Health Professional
Issue Areas/Comments
"Plan B" or Emergency Contraceptive Pills are an extremely safe and effective medication for preventing unwanted pregnancy. The vast majority of experts agree on this and believe Plan B should be available as an OTC medication. Unfortunately, the politics of birth control seem to have overtaken the common sense. If you want to prevent abortion, you need to prevent unwanted pregnancy. No woman should have to make the decision of what to do with an unwanted pregnancy. The more options available, the better. The FDA's expert advisory panel recommended with a 23-4 vote that EC be made available over the counter without prescription almost two years ago. We cannot allow politics to interfere with women's health.