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 : EC881
Submitter : Dr. Eric Peck Date & Time: 10/17/2005 10:10:47
Organization : Olathe ObGyn
Category : Health Professional
Issue Areas/Comments
The FDA should approve over the counter use of Plan B for emergency contraception. This provides an effective means of avoiding unwanted pregnancies and reducing the number of abortions in this country. Since it has been proven safe for adolescents as well as adults, and has been proven effective, there is no good reason not to approve its over the counter use.