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 : EC583
Submitter : Mrs. Patricia Brandon Date & Time: 10/12/2005 06:10:52
Organization : Mrs. Patricia Brandon
Category : Health Professional
Issue Areas/Comments
I am wanting Plan B emergency contraception to become available to women who need it to avoid unwanted pregnancies. As shown by research, Plan B contains hormones that reduce the risk of pregnancy when started within 120 hours of unprotected IC, barrier failure or rape. It works by delaying or inhibiting ovulation. All women deserve the right to use a medication that can help in these type of situations. Please consider allowing Plan B emergency contraception to be made available over- the-counter to all women who need it. Thank you for your serious consideration.