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 : EC305
Submitter : Mr. Carrie Mounier Date & Time: 09/20/2005 03:09:32
Organization : Childrens Hospital Los Angeles
Category : Health Professional
Issue Areas/Comments
GENERAL
GENERAL
I am very concerned that the FDA has chosen to delay their decision regarding providing emergency contraception over the counter. As a clinical social worker providing services to adolescents, I am aware of the benefits offered by emergency contraception in order to prevent unwanted pregnancies and unnecessary abortions. Emergency contraception has been determined to be safe and effective, which should be the only criteria used in the decision to provide FDA approval. It is not appropriate to use FDA approval as a tool to attempt to legislate women's behavior.