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 : EC2095
Submitter : Mr. Jason O'Neill Date & Time: 10/31/2005 06:10:50
Organization : Mr. Jason O'Neill
Category : Individual Consumer
Issue Areas/Comments
GENERAL
GENERAL
I am opposed to the constant delays 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 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.

Thank you for your time and consideration.