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 : EC2065
Submitter : Ms. Jeanne Devine Date & Time: 10/31/2005 06:10:40
Organization : Ms. Jeanne Devine
Category : Health Professional
Issue Areas/Comments
Emergency contraceptives are the most effective if taken within 24 hours after unprotected sexual intercourse - when a condom breaks, birth control is not used, or if a sexual assault occurs. Forcing women to get a prescription before they can obtain Plan B is an unwise and unnecessary burden on all women, especially poor women who may not have access to a physician. Moreover, requiring a physician's prescription increases the total cost of emergency contraception dramatically. I would like to voice my opposition to the constant delays in permitting emergency contraception to be sold over the counter without a prescription.