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 : EC2117
Submitter : Ms. Elizabeth Burke Date & Time: 10/31/2005 06:10:48
Organization : Ms. Elizabeth Burke
Category : Individual Consumer
Issue Areas/Comments
GENERAL
GENERAL
Emergency Contraception should be sold over the counter without a prescription. The FDA expert advisory panel recommended this with a 23-4 vote almost two years ago. Since EC is most effective if taken within 24 hours of unprotected sexual intercourse, the delay required by having to get a prescription is unreasonable.

If the cause of the delay in making this an OTC drug is simply politics, it's time to act like medical professionals. A safe, effective drug exists to provide an emergency back-up after assault, condom failure, or ordinary failures to use adequate birth control. Making it available in a manner that is timely and affordable would protect lives and good health.