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 : EC2083
Submitter : Ms. Linda Hiltabrand Date & Time: 10/31/2005 06:10:51
Organization : Ms. Linda Hiltabrand
Category : Individual Consumer
Issue Areas/Comments
GENERAL
GENERAL
Make Emergency Contraception available available over the counter.

The FDA's expert advisory panel recommended with a 23-4 vote that EC be made available over the counter without prescription almost two years ago. We cannot allow politics to interfere with women's health.

EC 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 EC dramatically.

Make Emergency Contraception available and allow women to make their own responsible decisions.