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 : EC1152
Submitter : Dr. Janice Bird Date & Time: 10/27/2005 04:10:46
Organization : Dr. Janice Bird
Category : Health Professional
Issue Areas/Comments
Emergency contraception must be made available over the counter to women of all ages. From my position 'in the trenches' as a practicing obstetricioan and gynecologist, access to EC at all hours from a pharmicist without a prescription is key to the success of unwanted pregnancy. Your own research has not found a safety reason to restrict its use as prescription only. Do you think that a couple who has a contraceptive failure at midnight, and requests a prescription for emergency contraception is going to get any better care from a telephone interview by me, rather than a pharmicist who screens for contraindications for use? Please, give all women access to over the counter emergency contraception!

Janice Bird, MD
Annapolis, Maryland