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 : EC683
Submitter : Mr. Richard Cochran Date & Time: 10/12/2005 06:10:07
Organization : Mr. Richard Cochran
Category : Individual Consumer
Issue Areas/Comments
B. If it could, would it be able to do so as practical matter and, if so, how?
It is impossible to imagine how some products (eg. Plan B) could be kept out of the hands of children under the age of 17.
In your letter, you state:

"The FDA?s drug center, the Center for Drug Evaluation and Research or CDER, completed its review of this application, as amended, and has concluded that the available scientific data are sufficient to support the safe use of Plan B as an over the counter product, but only for women who are 17 years of age and older."

Whether or not the CDER is correct in their assessment of the safety of Plan B for women 17 years of age and older, the question remains as to whether it is _effective_ for women of any age. While Plan B may be "effective" at preventing or terminating pregnancies, studies show that unrestricted availability of Plan B results in an increase in pregnancies and STDs, presumably due to behavioral changes.

Is it responsible for the FDA to ignore human behavior as a factor in deciding whether to ease restrictions on the availability of a product? I think not.