George E. Pataki
Governor
Executive Chamber
Capitol
State Street, Room 210
Albany, New York 12224 Re: A.116/S.3661 "Unintended Pregnancy Prevention Act" Dear Governor Pataki: I have sponsored the above referenced bill which has passed in the Assembly in each of the last three years. This legislation has the potential to prevent several thousand abortions a year in New York. This has been the case in other states in which emergency contraception (EC) has been made more easily accessible. According to the New York State Department of Health (NYSDOH), there were 120,349 induced abortions in 2002, of which 9,155 girls were seventeen and under. Medical experts, including the American College of Obstetricians and Gynecologists (ACOG), believe that increased access to EC will reduce the number of abortions in New York by at least one half. In the interest of preventing thousands of abortions a year, I respectfully urge you to sign this legislation into law. Emergency contraception has been found to be a safe and effective method for preventing unintended pregnancies. EC is most effective when used within seventy-two hours of unprotected intercourse. However, the sooner EC is taken the more effective it is. One dose of EC is followed by a second dose twelve hours later. Currently, a patient may obtain a prescription for EC from a physician, nurse practitioner, licensed midwife or physician’s assistant. Being able to obtain EC in a timely manner from a pharmacist when it is not feasible to get an appointment to see a physician, nurse practitioner, licensed midwife or physician’s assistant is critical. Many pharmacies are open on weekends and holidays while doctors’ offices are not. The American Medical Association (AMA), ACOG, the American Academy of Pediatrics (AAP), the American Public Health Association (APHA) and Food and Drug Administration (F.D.A.) scientific advisory committees recommend that EC be available over-the-counter (OTC), like cough medicine or aspirin. They take that stand because they know that it is highly safe and effective, has no contraindications, and must be taken soon by people whose circumstances may make it difficult to see a health care professional in time. This bill does not go that far; Federal law would not enable us to. This legislation creates a much more limited "behind the counter" access. It includes significantly more safeguards than the medical professionals tell us are needed. Background In 1999, the F.D.A. approved Plan B brand emergency contraception for prescription use. Subsequently, in 2003, after reviewing more than 15,000 pages of clinical data from approximately forty studies submitted with the OTC application, the F.D.A.’s Nonprescription Drugs and Reproductive Health Drugs Advisory Committees, by a 23 to 4 vote, overwhelmingly recommended that Plan B brand emergency contraception (which is Levonorgestrel, a form of progesterone) be licensed for OTC use and issued strong caveats that no age or distribution restrictions were warranted. The thinking on the part of these respected physicians and scientists was that EC is a safe form of birth control – safe enough to allow it to be purchased OTC without requiring that patients interact with a healthcare professional. Additionally, responding to data from one actual use study (AUS) involving 585 women of reproductive age, the F.D.A.’s Advisory Committee voted unanimously that there is no evidence that non-prescription availability of Plan B leads to the substitution of EC for the regular use of other contraceptive methods. By a vote of 27 to 1, the Committee also considered the data from the AUS to be generalizable to the overall population, including teenage women. However, Steven Galson, Acting Director of the F.D.A.’s Center for Drug Evaluation and Research, did not follow the recommendation of his own Advisory Committees and, on his own, rejected the application to allow OTC access. Description of legislation Known as the Unintended Pregnancy Prevention Act, my legislation would make emergency contraception more accessible in New York. It would allow physicians, nurse practitioners, licensed midwives and physician assistants, all working within their scope of practice, to choose to prescribe and order a non-patient specific regimen to a licensed pharmacist or registered nurse to dispense (and, in the case of a registered nurse, to also administer) emergency contraception. This legislation is clearly not a mandate. Only those who choose to prescribe or dispense EC would do so. Currently, in New York State, we allow physicians to prescribe and order a non-patient specific regimen to a registered nurse so that such nurse may administer immunizations, treatment for anaphylaxis, and purified protein derivative (PPD) tests. This legislation amends the Education Law to apply the mechanism of the non-patient-specific prescription or order to the dispensing and administering of EC. The bill also includes several provisions for education and training for licensed pharmacists who wish to accept non-patient specific prescriptions for EC. Though pharmacists are abundantly qualified, this legislation includes additional safeguards. Licensed pharmacists study for six years and receive the most extensive pharmacology training of any healthcare professional. Their training includes knowledge of drug interactions and they are well versed in current health issues. Any licensed pharmacist who chooses to dispense EC must do so in accordance with written procedures and protocols agreed to by the prescribing practitioner and the pharmacist and must successfully complete emergency contraception drug therapy education and training. Pharmacists will be following the orders written by a physician, nurse practitioner, midwife or physician’s assistant. Whenever a pharmacist dispenses EC under the bill, he or she must also provide a fact sheet to the patient that includes such information as clinical considerations and recommendations for use of the drug, the appropriate method for using the drug, the importance of follow-up health care, and health care referral information. This fact sheet will be developed by the Commissioner of Education in consultation with NYSDOH and ACOG. Dispensing or administering EC under the bill – as with all non-patient-specific prescriptions or orders – must be pursuant to regulations of the Commissioner of Education. Those regulations may set appropriate limitations. Therefore, this legislation does not create "over the counter" access, as is the case for aspirin or diet pills (that are not without their own risks) but rather much more limited "behind the counter" access. A patient must interact with a healthcare professional, a pharmacist or registered nurse acting under regulations of the State Education Department. Health professionals and victims’ advocacy groups support increased access to EC Every one of these organizations sees the benefit in lowering the number of abortions by having a safe method for preventing unintended pregnancies. Health professionals support increased access to EC This legislation is supported by the state chapters of ACOG, AAP, the NYS Nurses Association, the NYS Association of Licensed Midwives, the Pharmacists Society of the State of New York, the NYS Council of Health-System Pharmacists, the NYS Association of County Health Officials and many other health professional organizations. In 2004, the AMA House of Delegates approved, without debate, a resolution opposing the F.D.A.’s decision to deny Barr Laboratories’ application for OTC status of Plan B. Nationally, ACOG, AAP, the AMA and the APHA support over-the-counter availability of EC, without any of the limitations and safeguards contained in this bill. Sexual assault victims, including adolescent victims, must have increased access to EC This legislation is supported by the New York State Coalition against Sexual Assault. New York State law now requires hospitals and emergency rooms to offer EC to victims of sexual assault. However, many sexual assault victims do not go to an emergency room or any authority or heath care professional. In 2002, Family Planning Advocates (FPA) and the New York Coalition Against Sexual Assault (NYSCASA) surveyed New York hospitals and found that an estimated 6,070 patients were treated because they were sexually assaulted. (Unlike other crimes, the number of sexual assaults remains fairly constant from year to year.) The U.S. Department of Justice, in its report Rape and Sexual Assault: Reporting to Police and Medical Attention, 1992-2000, found that only 25% of sexual assault victims seek care at a hospital. Based on this statistic, we may safely estimate that 24,280 women were sexually assaulted in New York State during 2002, and yet three quarters of those women did not receive treatment in a hospital. By making EC available through a pharmacist or registered nurse, this legislation could potentially help approximately 18,000 victims of sexual assault a year avoid an unintended, and most probably an unwanted, pregnancy. Victims of sexual assault are most often younger women and adolescents. According to Tjaden and Thoennes, researchers from the National Institute of Justice, "Rape is primarily a crime against youth." A study conducted by National Violence Against Women reported 54% of rape victims were between the ages of 12-17. Similarly, the National Women’s Study found that 62% of sexual assault victims were under seventeen years of age. The statistics support the fact that there is a tremendous need for prevention of unintended pregnancies in very young women. Victims of domestic violence, including adolescent victims, must have increased access to EC This legislation is supported by the New York State Coalition against Domestic Violence. It is a sad but well known fact that one method perpetrators of domestic violence have for controlling their victims is to control the victim sexually and reproductively. Every two years, Youth Risk Behavior Survey (YRBS) conducts a study of high school students in grades nine through twelve throughout the entire country. In 1997 and in 1999, a question was added to the Massachusetts survey regarding teen violence. One in five girls reported being sexually or physically abused by a dating partner and of those females, one in ten was sexually abused. These figures indicate that there is a real need for teenage women to have the ability to prevent potential unintended pregnancies in a safe and effective way. Victims of both domestic violence and incest who are sexually assaulted are often prevented, by their abusers, from using any regular method of birth control. By making EC more easily accessible, sexual assault victims would be able to prevent pregnancies that create further entanglement with their abusers and it would allow victims of domestic violence to have more control over their own reproductive health and, therefore, their own lives. Misconceptions and reality There have been a number of allegations regarding this legislation which I would like to address below. In so doing I believe the need to make this legislation law becomes abundantly clear. EC is not an abortifacient A common misconception is that EC is an abortion pill. It is not the same as RU-486, also known as Mifepristone, which is the abortion pill. EC is merely a slightly higher dose of birth control pills. Birth control pills are safely taken by thousands and thousands of women every day. When taken within seventy-two hours of unprotected intercourse, EC greatly reduces the risk of pregnancy. EC works by temporarily interrupting a woman’s hormonal patterns. It alters the release of hormones from the ovaries and inhibits ovulation and, in some instances, inhibits fertilization or implantation. It does not disturb an already established pregnancy, which is defined by the National Institutes of Health, the U.S. Department of Health and Human Services and ACOG as the implantation of a fertilized egg in the uterus. EC also does not adversely affect a developing fetus should it be taken after implantation. As early as February of 1997, the F.D.A. issued a notice in the Federal Register that EC would not be effective if a woman is already pregnant and that there is no evidence that it would have an adverse effect on an established pregnancy. More recent studies have confirmed this. Therefore, EC does not cause an established pregnancy to be aborted. However, by preventing an unintended pregnancy, it prevents a potential abortion. F.D.A. is not being circumvented Some critics of this legislation feel that A.116/ S.3661 is an attempt to evade the F.D.A.’s requirement that EC be dispensed or administered pursuant to a prescription or order. It does not do so – it is well established that a non-patient-specific prescription or order is an appropriate form of prescription or order. Registered nurses administer immunizations, the emergency treatment of anaphylaxis and PPD tests, under non-patient specific regimens, under New York State laws enacted starting in 1999. All these things required a prescription or order under Federal law. This legislation adds EC to that existing list of drugs that registered nurses may administer under a non-patient specific order and allows licensed pharmacists to dispense EC under a non-patient-specific prescription and written protocols agreed on with the prescriber, all pursuant to Commissioner of Education regulations. "Standing orders" (essentially a "non-patient-specific" prescription) and written protocols are standard practice across the country and across the health professions. In forty-four states, including neighboring Massachusetts, Connecticut, Vermont and New Jersey, pharmacists may administer immunizations under standing orders and written protocols. Seven states – New Hampshire, California, Alaska, Washington, Hawaii, New Mexico and Maine – have laws allowing women access to EC similar to my bill. The Massachusetts legislature recently voted, by an overwhelming majority, to allow women access to EC without a patient-specific prescription. None of these laws is challenged as being contrary to F.D.A. requirements for a prescription or order. These states have placed public health before politics. New York must do the same. Additionally, several countries, including England, France, Portugal, Israel, Sweden, Norway, Denmark, Finland, Albania, South Africa, Belgium, Morocco and parts of Canada have permitted easy access to EC for many years. Increased access to EC will not increase promiscuity among teens Another misconception is that by giving women, especially young women, access to EC the rate of sexually transmitted infections (STIs) will increase and it will lead to more risky sexual behavior. However, a study providing EC to 2,117 young women ages 15 to 24, reported in the January 5, 2005 issue of the Journal of the American Medical Association (JAMA) concludes that by giving young women access to EC it does not negate the ability of women to act responsibly. The study confirmed that EC does not increase promiscuity or unprotected sex among women, nor does it cause women to abandon their regular birth control methods. Moreover, there are less expensive over the counter methods of birth control available to very young women already. The average cost for EC is approximately forty dollars, a probable discouragement for young women. There is, currently, no age requirement in order to purchase condoms or spermicides in a pharmacy, grocery store or convenience store. Under this legislation, which requires a woman to interact directly with a pharmacist or registered nurse, access to EC would be significantly more difficult than access to over-the-counter birth control. Among young women under the age of nineteen, there were 21,584 abortions performed in 2002 according to NYSDOH. Increased access to EC will not only reduce the number of abortions young women have, but reduce the cost and health risks associated with pregnancy, childbirth and abortion. A commonsense risk-benefit analysis indicates that increased access to EC will enable young women to pursue a better, healthier future by preventing an unintended pregnancy in a safe and timely fashion. Labeling instructions for EC will not be misunderstood Opponents of EC claim that young women will be unable to read the label on the medication properly. In a letter dated May 6, 2004, to the makers of Plan B brand EC, Barr Laboratories, the F.D.A. stated that because only 29 of the 585 women in the label-comprehension study were 16 years of age or younger, there was not enough data to support a conclusion that Plan B could be used safely by young adolescent women. That objection was directed at the application for OTC access. James Trussell, director of the office of population research at Princeton University and a member of the F.D.A. Advisory Committee, said that in approving other products to be sold over the counter, the F.D.A. never raised the issue of label comprehension among young teenagers before. He added, "The White House has now taken over the F.D.A." In 2002, an article in The New England Journal of Medicine reported that "The labeling instructions for emergency contraceptive products are simpler than those for many products that are currently available without a prescription, including ibuprofen . . ." (Several hundred people die each year in the United States from overdoses of aspirin.) The article went on to state that in an earlier OTC label comprehension test, a random sample of 663 women in malls and family-planning clinics in eight U.S. cities were given eleven different labels to read. By reading the labels, more than 85% of the women understood how to use EC safely and effectively when reading seven of the eleven labels. Many years of OTC access to EC in France has shown that women have not had problems understanding the instructions for its use. By interacting with a pharmacist or registered nurse, as set forth in my legislation, women, including young women, will have the opportunity to ask questions and have them answered by a healthcare professional who will also provide a verbal explanation and a fact sheet, as described earlier. Additionally, a pharmacist may refuse to dispense any medication if he or she reasonably feels that it would endanger someone. This same discretion would apply to EC. However, even if someone were to take the two doses of EC at the wrong time, it is expected that it would still be effective and there are no adverse affects. In its study of EC, the World Health Organization found that if the standard two doses of EC were taken at the same time, they would be as effective as they would be if taken the suggested twelve hours apart. This finding has not been widespread within the U.S because, as yet, there has been no report published from clinical trials conducted in the U.S. EC is safe and does not contain harmful levels of "powerful" hormones Critics of this legislation erroneously believe that EC contains dangerous levels of the hormone estrogen. Emergency contraception does not contain estrogen. There had been Preven (a type of EC) on the market that contained estrogen, but Preven is no longer on the market. Barr Laboratories acquired Preven brand and now produces only Plan B brand EC. Currently, Plan B brand is the only brand of EC on the market. Plan B brand EC does not contain estrogen, but only progesterone. Even if a brand of EC containing estrogen were to come back on the market, EC is not taken daily but rather is a double dose taken in an emergency by women who are clearly not postmenopausal. (The one study cited by opponents that showed a health risk for "hormones" was the Women’s Health Initiative. In 2002 the study found that a daily dose of estrogen in postmenopausal women poses certain dangers. The dosage was reduced and a warning label was added. It is important to note that the estrogen used in postmenopausal pills is a different derivative than that formerly used in EC.) If EC did still contain estrogen, a woman would have to take a double dose of EC three times within one month to receive the same amount of estrogen that is in one month’s supply of routine, low dose birth control pills. There are no serious contraindications even if a woman should use EC frequently; it would merely result in a disrupted menstrual cycle. Pharmacists’ role is appropriate The Medical Society of the State of New York raised a question regarding pharmacist discretion in a 2003 letter. However, the pharmacist’s role under this bill is entirely appropriate to the pharmacist’s education, training and professional responsibility. The pharmacist will be following orders written in basically the same manner as prescriptions are currently written. In addition, the pharmacist will act under written protocols of the prescriber and regulations of the Commissioner of Education. Pharmacists will be required to successfully complete EC drug therapy education and training and present the patient with a fact sheet. All this is being done for a drug that should be available over-the-counter, according to the AMA, ACOG, AAP, APHA and F.D.A. scientific advisory committees. Physician liability is not increased The Medical Society was also concerned with physician liability. However, ACOG’s legal advisors, in a letter dated March 27, 2003, addressed this issue. The conclusion was that the risks of liability to the physician who would order a non-patient specific regimen as described in my bill "appear to be minimal" and "in states where such a system has been in effect for several years, there apparently has been no malpractice litigation to date arising from patient injury from the short-term use of the drug." Two years later, this remains true. Definitions of EC are consistent with current law The Medical Society’s third concern was the discrepancy in the definitions of EC that appeared in my bill and the bill sponsored by Assemblywoman Susan John requiring the offering of EC in hospital emergency rooms. The John bill was subsequently amended before it was enacted. The definitions in that law and this bill, though not identical, are consistent with each other. Conclusion -- New York women deserve better health options than unintended pregnancies and abortions EC is designed to be just that – emergency contraception – to be used when other methods of contraception fail or in cases of rape, incest or human error. Many pregnancies, births and abortions are far more dangerous to a woman’s health, especially a young woman’s health, than EC. The increased access to EC in Washington State reduced both the teen pregnancy rate and the abortion rate. Washington’s teen pregnancy rate dropped by 7% the first year that EC was available without an individual prescription and the abortion rate reached the lowest level in two decades, dropping 5% from 1997 to 1998. By allowing women the chance to prevent an unintended pregnancy, the abortion rate will drop, healthcare costs will decrease and young women will not have to start their adult lives with the difficult decision of whether to have a baby (often as a single mother), have an abortion, or give a baby up for adoption. By allowing easier and more timely access to EC, all women of reproductive age will have the opportunity to have a healthier and more promising future. ACOG, the AMA, AAP, APHA and seventy other associations are working throughout the country to make EC available OTC. They agree that EC is a safe method of birth control and that when the F.D.A. ignored the recommendation of its Advisory Committee, it placed politics over public health. In a statement issued by ACOG immediately after the F.D.A. refused to approve OTC access, Wendy Chavkin, MD, MPH, professor of public health and ob-gyn at the Columbia University Mailman School of Public Health and College of Physicians and Surgeons, stated:

"It is quite a shock and disappointment that the F.D.A. is making decisions in response to political pressure rather than to scientific evidence and concern for the public health. Emergency contraception could significantly reduce the troubling rates of unintended pregnancy in the United States."