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 : EC2014
Submitter : Dr. michele hugin Date & Time: 10/31/2005 05:10:41
Organization : Dr. michele hugin
Category : Health Professional
Issue Areas/Comments
GENERAL
GENERAL
The FDA should make the morning after contraceptive Plan B an OTC drug. Unplanned pregnancy places huge burdens on women, their families and society as a whole. There are numerous studies to show that Plan B is safe. I thas also been demonstrated that the availability of emergency contraception does not increase irresponsible sexual behavior. Half of all pregnancies in the USA are unplanned and half of those end in abortion. Plan B PREVENTS abortion. Induced abortion is safer than carrying a pregnany to term but avoiding pregnancy in the first place is the safest option. Please make this safe and effective option available to my patients.
Sincerely,
Michele Hugin MD FACOG