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 : EC950
Submitter : Mrs. Jan McDonald Date & Time: 10/27/2005 08:10:53
Organization : Mrs. Jan McDonald
Category : Animal Feed Industry
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC drug product?
If you make Plan B available over the counter, you will have to make birth control pills available also. Imagine the law suits..there are many side effects to both.

Keep in mind that there are 3 ways in which Plan B can work
1. Prevention of ovulation
2. Prevention of fertilization of the egg by the sperm
3. Prevention of a fertilized egg from implanting in the wall of the uterus, i.e. post-fertilization effect. If one believes that life begins at conception, emotional problems could result from that.

Would you want your teenage daughter to be able to go buy that?

Thanks for your consideration.

Jan