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 : EC738
Submitter : Mr. Brian Caulfield Date & Time: 10/13/2005 08:10:59
Organization : Mr. Brian Caulfield
Category : Individual Consumer
Issue Areas/Comments
B. If it could, would it be able to do so as practical matter and, if so, how?
I think it would be confusing to consumers and would be unenforceable as a practical matter. Women under 16 would be able to buy it off the shelves, or they would be able to get an older friend to do so for them.
If ordinary birth control pills are by prescription only, it seems that the much stronger Plan B pills, which contain a higher dose of the prescription medicine, should be by prescription only. Plan B should not be sold OTC at all.

It is not good medicine to give teens, even 17 years old, easy access to a strong drug, since at that age they are not able to legally drink or buy cigarettes.

Who will monitor these young girls' use of Plan B? In theory they could use the drug every weekend.

The drug Plan B is also dangerous to an already conceived embryo. We need to do more research on whether Plan B causes a very early abortion, and whether users should be alerted to this possibility. It is unfair to women to sell them a drug that is called contraception, when it may also prevent an already conceived embryo from implanting. That is deceptive advertising and could get the FDA in big legal trouble if a case is brought.