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 : EC2120
Submitter : Mr. James Gallagher Date & Time: 10/31/2005 06:10:46
Organization : Mr. James Gallagher
Category : Individual Consumer
Issue Areas/Comments
I would like to express my concern regarding the constant delays in permitting emergency contraception to be sold over the counter without a prescription.

Emergency Contraception is most effective (95%) 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.

The FDA's expert advisory panel recommended with a 23-4 vote that Emergency Contraception be made available over the counter without prescription almost two years ago. Why have you delayed implementing these recommendations? We cannot allow politics to interfere with women's health.