Res. No. 522 Title Resolution urging the Food and Drug Administration (FDA) to switch the FDA-approved emergency contraceptive drugs, Preven and Plan B, from prescription to over-the-counter status. Body By Council Members Moskowitz, Quinn, Gioia, Reyna, Clarke, Boyland, Gerson, Jackson, Koppell, Lopez, Nelson, Perkins, Reed, Brewer and Katz Whereas, Emergency contraception is a medication used to prevent a woman from ovulating, or, if she has already ovulated, to prevent an egg from subsequently being fertilized or implanted in the uterine wall, thereby preventing pregnancy when other contraceptive methods have failed or unprotected intercourse has occurred; and Whereas, In 1997, the Food and Drug Administration (FDA) approved certain combinations of the medications that are used in standard birth control, including estrogen and progesterone, as safe and effective methods of reducing the risk of pregnancy after sex; and Whereas, An article in the New England Journal of Medicine claimed that the use of emergency contraception could prevent as many as 1.7 million unintended pregnancies that occur each year in the United States, including as many as 800,000 pregnancies which now result in abortion; and Whereas, The FDA approved guidelines for emergency contraceptives call for two doses of hormones, taken 12 hours apart from each other, where the first pill must be taken within 72 hours; and Whereas, According to a report by the Task Force on Postovulatory Methods of Fertility Regulation entitled, "Timing of Emergency Contraception with Levonorgestrel or the Yuzpe Regimen", emergency contraceptives are substantially more effective the sooner they are taken after unprotected sex; and Whereas, Emergency contraception will reduce a woman's risk of pregnancy by up to 89% if taken within 72 hours of unprotected intercourse; and Whereas, Currently, women face numerous barriers to accessing emergency contraceptives within the 72 hour time period because of the difficulty contacting a physician and getting their prescription filled, especially on weekends and in evenings when contraceptive accidents are most likely to occur; and Whereas, England, New Zealand, France and the states of Washington, Alaska and California have all passed laws making emergency contraception available for distribution that imitates "over-the-counter" status; and Whereas, The FDA is currently considering a request to make emergency contraception an over-the-counter pharmaceutical, a proposal that is supported by the American College of Obstetricians and Gynecologists and the American Medical Association; and Whereas, The dosage and regimen for emergency contraceptives is the same for all women; and Whereas, Studies show that women who take emergency contraceptives are able to follow the instructions on the labels and complete the full the regimen independently of physician supervision; and Whereas, Women who take emergency contraceptives can diagnose themselves, because the only condition of taking the medication is unprotected intercourse; and Whereas, Emergency contraceptives meet the FDA's criteria for all new over-the-counter drugs, including low toxicity, no potential for overdose or addiction, no risk of causing birth defects, and uniform dosage; and Whereas, Given that the treatment is safe for self-administration and self-medication and that the condition is one that can be self-diagnosed, there is no medical reason to require physician supervision; and Whereas, Emergency contraceptives are an important reproductive health option, as they are the only means of preventing a pregnancy after unprotected sex or if contraception has failed; now, therefore, be it Resolved, The New York City Council urges the Food and Drug Administration to switch the FDA-approved emergency contraceptive drugs, Preven and Plan B, from prescription to over-the-counter status. DR LS #1040 |1013|