From: MTCHOICE [mtchoice@mt.net] Sent: Tuesday, December 16, 2003 6:32 PM To: fdadockets@oc.fda.gov Subject: I support Plan B's application. Dear Commissioner, I want to express my support for Docket 01P-0075. Switching emergency contraception to over-the-counter status is critical to eliminating barriers to use and in improving women’s health. I applaud today's FDA advisory committee's overwhelming support of Plan B's over-the-counter application. The vote of 27-4 is a clear indication that this application has the support of science and the general public. I strongly support the reclassification of Emergency Contraceptives (EC) as an over the counter drug. Women in the UK, France, and other European countries can already buy EC directly from a pharmacist. Making EC available over-the-counter would eliminate an unnecessary barrier to women’s access to this important contraceptive option. EC is a safe and effective method of contraception, and women who have used it report high levels of satisfaction. It prevents a pregnancy from starting, and will not affect an existing pregnancy. EC is an important part of preventing unintended pregnancies, empowering sexual assault survivors and reducing the abortion rate. Currently, EC can be difficult to obtain in a timely manner because women must obtain a prescription in order to use them. In a rural state like mine, women may have to travel great distances to reach the nearest doctor or clinic, making a prescription difficult, if not impossible, to obtain within the recommended time frame. Even under less extreme circumstances, obtaining a prescription for EC can be problematic. Lack of access to emergency contraception may contribute to higher rates of unplanned pregnancy in the U.S. compared to countries where emergency contraception is widely available. Negative health outcomes – including delayed or inadequate prenatal care, increased likelihood of low birth weight and death in the first year of life, increased risk of the mother being physically abused, and economic hardship – are strongly associated with unintended pregnancy. Despite its enormous potential, anti-choice groups are opposing the proposed over-the counter status of emergency contraception. In order to hinder women's access to this important method of contraception, many groups falsely claim that emergency contraception is an abortifacient, and they disseminate other misinformation about its safety and efficacy. I hope you will be able to see past their deception in order to do what is best for women’s health. In short, EC has all of the characteristics of an over-the-counter drug: it is safe, effective, and simple to use; it is not associated with any serious or harmful side-effects; it is not dangerous to women with particular medical conditions; and it does not lead to riskier behavior or less frequent use of other forms of contraception. EC has enormous potential to reduce unintended pregnancy and the need for abortion. In fact, wider access to and use of EC is perhaps the single most promising avenue for reducing this country’s high rate of unintended pregnancy. If women simply saw EC in pharmacies, awareness would increase tremendously. This could make a crucial difference to millions of women. However, without speedy and uncomplicated access to EC, women cannot take full advantage of this important contraceptive option. Making EC available over-the-counter would remove this barrier to access, and help to improve women’s health. Please, support switching the status of emergency contraception from Rx to over-the-counter. Sincerely, Morgan Sheets, Executive Director NARAL Pro-Choice Montana PO Box 279, Helena, MT 59624