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 : EC1657
Submitter : Ms. Leanne Sedowski Date & Time: 10/31/2005 02:10:14
Organization : Ms. Leanne Sedowski
Category : Individual Consumer
Issue Areas/Comments
FDA should approve an OTC emergency contreception pill. It is ridiculus that this has dragged on for 2 years. Almost every other developed country has the pill, but why does the US lag behind? If people object to taking the pill on religious grounds, that's fine. They don'thafta take it. But please let those of us who might need it one day have access to this important drug.
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 Plan B 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

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. WHY IS THIS TAKING SO LONG!?