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 : EC941
Submitter : Ms. Tina Boyer Date & Time: 10/27/2005 08:10:35
Organization : Ms. Tina Boyer
Category : Health Professional
Issue Areas/Comments
Plan B (emergency contraception) is a crucial contraceptive option for women attempting to prevent an unplanned pregnancy. Plan B has the potential to significantly reduce the number of undesired pregnancies in the United States and therefore reduce the number of abortions each year. This drug is of particular importance to rape victims who may be concerned that they will become pregnant as a result of sexual assault. It is vital that the FDA exercise the same standard with this safe and effective drug as it does with other over-the-counter medications.