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 : EC732
Submitter : Dr. Lynne Divis Date & Time: 10/13/2005 08:10:17
Organization : Dr. Lynne Divis
Category : Individual Consumer
Issue Areas/Comments
Marketing Plan B as an OTC to the 17-and-older subpopulation will in no way prevent underage girls from obtaining this drug. (Setting legal age requirements for cigarettes and alcoholic beverages has by no means prevented underage smoking and drinking, so let's not fool ourselves. Illegal drugs of abuse provide another illustration.)

Believing that this drug will get them "out of trouble," these girls will only engage in sexual activity all the more. What percentage of these girls, on learning of their pregnancy, decide to keep their baby? What percentage of "boyfriends" leave their "girlfriends" when she makes this decision? How will these very young mothers support their child all alone?

As a professor of chemistry who teaches introductory and physiological chemistry to pre-nursing majors, I have seen single mothers try to better their lives by going back to school to obtain a nursing degree. INVARIABLY, these women CANNOT HANDLE the demands of both college- level study and parenting and end up DROPPING OUT OF MY FIRST-SEMESTER CLASS. They NEVER FINISH THEIR FRESHMAN YEAR, let alone finish their four-year degree. What kind of future is in store for these young women and their children?

Further, increased sexual activity leads to increases, not decreases, in STDs. Scientific studies world-wide have borne this out. The FDA's job is to protect the public health, not increase public disease.

Marketing Plan B as an OTC - regardless of the packaging - would be a TREMENDOUS DISSERVICE TO GIRLS AND WOMEN. Please be sure to do your job properly.

Thank you.