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 : EC933
Submitter : Dr. Daniel Pomerantz Date & Time: 10/27/2005 08:10:06
Organization : Dr. Daniel Pomerantz
Category : Health Professional
Issue Areas/Comments
GENERAL
GENERAL
I am writing to voice my concern about the FDA's failure to make a decision on the application to make Plan B emergency contraception (EC) available over the counter.

Unintended pregnancy is a significant public health problem in the United States, and women deserve a chance to prevent it. Plan B is a safe, effective, and easy-to-use contraceptive option that will help reduce the need for abortion.

I urge the FDA to grant Plan B over-the-counter status for all women.