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 : EC571
Submitter : Mr. William Burgess Date & Time: 10/12/2005 06:10:05
Organization : Mr. William Burgess
Category : Individual Consumer
Issue Areas/Comments
GENERAL
GENERAL
Marketing the so-called 'morning after pill' as an OTC drug is morally reprehensible and will cause harm to unsuspecting women and teenagers who do not have access to proper medical care. Not commonly known is that such drugs cause chemical abortions which, if discovered later by the woman, would cause severe guilt and emotional trauma. Young women or teenagers could also be subject to male abusers such as adult men abusing minors or incestitious relationships that the father or other family member wishes to keep secret. There are also health risks involved including: nausea, vomiting, infertility, breast tenderness, ectopic pregnancy (which can be life threatening) and blood clot formation.

'Emergency contraception' also offers no protection against sexually transmitted diseases including AIDS.

There are no long term studies to show whether women will be permanently damaged, or at-risk from such diseases as cancer from the high dosage of these chemicals.

For all of the above reasons, I urge you to continue regulating 'morning after pills' as prescription drugs and to not allow such drugs to be sold over the counter. Thank you for your consideration. - William Burgess