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 : EC936
Submitter : Dr. Nancy Rudd-McCoy Date & Time: 10/27/2005 08:10:43
Organization : Nancy Rudd-McCoy, MD, PC
Category : Health Professional
Issue Areas/Comments
GENERAL
GENERAL
As a board certified OB GYN in private practice, it has always been my belief that every child should be wanted. Our civilization has brought us to the point where that is possible. Nevertheless, every day I see pregnant women (and girls!) who conceive thoughtlessly. I see children being raised by women (and girls!) who aren't competent to take care of themselves, let alone a child. When one is young and idealistic, it seems that education is the answer, but most people choose to drift through life and choose not to think. As a consequence, in my practice, I try to make things simple for patients and eliminate obstacles. This strategy relates to the issue of restricting the "morning after pill" to adults only. Teen agers are bombarded by messages from the media and advertising that sex is great. It is not in their nature to think of consequences. If an emergency contraceptive is available without obstacle and the public is informed of its availability by the usual pharmaceutical industry commercials, it should decrease the incidence of unwanted pregnancies. All the scientific data show this medication to be safe. There is no physiologic difference between a woman (girl!) at 15 vs 25, when she wakes up the next morning and, hopefully, some thought process kicks in, whereas the night before it was all instinct. I fear that, for the 1st time in my 54 years, the FDA is making decisions based on politics, not science.