Docket Management
Docket: 00N-1256 - Over-the-Counter Products
Comment Number: EC -87

Accepted - Volume 6

Comment Record
Commentor Dr. Steven Crawford Date/Time 2000-07-02 13:16:35
Organization Dr. Steven Crawford
Category Health Professional

Comments for FDA General
Questions
1. General Comments My name is Steven W. Crawford, MD I am a practicing obstetrician gynecologist. I strongly OPPOSE making oral contraceptive pills over-the-counter for many reasons. 1.)Annual exams. Annual examinations results in cervical and breast cancer screening. High-risk candidates for oral contraceptive pills are found and another contraceptive choice can be recommended. Over-the-counter oral contraceptives will result in women not having their annual examinations, I can guarantee you that. 2.)Physiology. Women I have treated over the last seven years do NOT know normal menstrual cycle physiology. I inform patients every day that ovarian cysts are a normal part of the menstrual cycle, and most are shocked that they form cysts. I inform them that corpus luteum cysts are a normal part of the menstrual cycle. Using oral contraceptives not only treats ovarian cysts that cause pain, but also endometriosis, dysmenorrhea, etc. Women, in general, need a discussion with their physician regarding normal menstrual cycle physiology and what benefits, risks and alternatives are available versus oral contraceptives. Overall, I find that women benefit immeasurably by seeing their physician annually. Making oral contraceptive pills over-the-counter would result in more use in women over age 35 who smoke, thus resulting in increased thromboembolic events. More women would erroneously use oral contraceptive pills resulting in unplanned pregnancies, irregular menstrual patterns and possible hormonal fluctuations making PMS and mood swings more erratic. We would see perimenopausal women taking oral contraceptives to stop irregular bleeding, possibly masking a uterine cancer. We also would see women taking oral contraceptives continuously to stop menses all together, resulting in an increase in endometrial hyperplasia, and possibly endometrial cancer. I freely admit that making oral contraceptive pills available as an over-the-counter product will further erode my income as a gynecologist. Insurance companies and government have already eroded my income to the point that I plan to pursue business interests to make up the losses that are bleeding me. This letter is not to preserve my income, as I will not see the effects significantly. This letter is for the health interests of women and NOT big money pharmaceutical companies who will make even more money somehow if oral contraceptive pills are allowed to go over-the-counter. This letter has been written to see that women's health care in America will continue to be the best in the world. Making oral contraceptive pills over-the-counter will greatly harm women of all ages in the United States. The FDA will create more money for big pharmaceutical companies at the expense of our female population's health care. Sincerely, Steven Crawford, MD Portsmouth, OH




EC -87