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 : EC883
Submitter : Mrs. Lexie Hallahan, DTR Date & Time: 10/17/2005 11:10:54
Organization : Mrs. Lexie Hallahan, DTR
Category : Health Professional
Issue Areas/Comments
GENERAL
GENERAL
I strongly support giving women greater access to emergency contraceptive by approving the decision that would make the emergency contraceptive pill Plan B available over-the-counter. Three times the FDA has delayed the decision and with Susan Wood, the Director of the FDA's Office on Women's Health resigning in protest, now is the time to approve this drug and assure access for women of all means and income levels to Plan B.