COMMENTS ON THE APPLICATION TO SWITCH PLAN B® FROM PRESCRIPTION-ONLY TO OVER-THE-COUNTER STATUS
Joint Public Meeting of the FDA Advisory Committees on Reproductive Health and Non-Prescription Drugs
December 16, 2003
INTRODUCTION
NARAL Pro-Choice America and our co-signers[(] respectfully submit these comments in support of the application to switch the emergency contraceptive Plan B® from prescription-only to over-the-counter status. NARAL Pro-Choice America is a 501(c)(4) national grassroots advocacy organization with hundreds of thousands of members and a state affiliate network. NARAL Pro-Choice America is committed to ensuring women’s access to the full range of reproductive health options, including preventing unintended pregnancy, bearing healthy children, choosing adoption, and choosing legal abortion. We believe that increasing access to emergency contraception (EC) is one of the most promising avenues for reducing unintended pregnancy and the need for abortion, and we argue that Plan B®, an emergency contraceptive pill (ECP) containing the progestin levonorgestrel, should be made available over-the-counter.
I. IMPROVED ACCESS TO EMERGENCY CONTRACEPTION IS CRITICAL TO REDUCING UNINTENDED PREGNANCIES AND IMPROVING WOMEN’S HEALTH
ECPs are a concentrated dosage of ordinary birth control pills that dramatically reduce a woman’s chance of becoming pregnant. In fact, Plan B® can reduce a woman’s chance of becoming pregnant by up to 89 percent if taken within days of unprotected sex.[1] ECPs do not cause abortion; rather they prevent pregnancy by inhibiting ovulation, fertilization, or implantation before a pregnancy occurs.[2] EC has a tremendous potential to reduce the number of unintended pregnancies and the need for abortion. Approximately three million unintended pregnancies occur annually in the United
States.[3] More than half of these unintended pregnancies happen to women using a regular contraceptive method during the month that they became pregnant.[4] Increased use of ECPs could reduce unintended pregnancies by half, thereby greatly reducing the need for abortion.[5] In fact, a 2002 study by the Alan Guttmacher Institute revealed that ECP use was likely responsible for up to 43 percent of the decline in the abortion rate between 1994 and 2000 – with ECP use preventing over 50,000 abortions in 2000 alone.[6]
Unfortunately, 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.[7] 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.[8] By increasing women’s contraceptive options, EC gives women greater control over their reproductive lives and thereby improves the health and well-being of women and their families.
Despite EC’s tremendous potential in reducing unintended pregnancies and the need for abortion, numerous barriers to access still exist. Significantly, EC can be difficult to obtain in a timely manner because women must obtain a prescription to use it. [9] First, many women lack a regular health care provider. Second, timely access to a provider can be difficult. For example, if a couple is faced with a broken condom on a Friday night, and the woman’s doctor’s office is closed over the weekend, she might have to wait until the following Monday – three days later – to obtain a prescription for EC. Women in rural areas may have to travel great distances to reach the nearest doctor or clinic, making a prescription within the relevant time frame after unprotected sex difficult, even impossible, to obtain. Even under less extreme circumstances, obtaining a prescription for EC can be problematic. A 2000 study of the Emergency Contraception Hotline (1-888-NOT-2-LATE), a 24-hour, automated phone line that provides the names and telephone numbers of clinicians who prescribe EC in the caller’s geographic area, found that even when calls to clinicians were made during business hours about one in four calls did not result in an appointment or a telephone prescription from a hotline health care professional within 72 hours.[10] Because ECPs are more effective the sooner they are used,[11] the obstacles associated with obtaining a prescription for ECPs pose a serious threat to women’s health.
Additionally, making EC available over-the-counter would greatly assist sexual assault victims. Each year, approximately 25,000 women in the United States become pregnant as a result of rape.[12] An estimated 22,000 of these pregnancies — or 88 percent — could be prevented if sexual assault victims had timely access to emergency contraception.[13] Hospitals could help alleviate some of the trauma associated with sexual assault by providing sexual assault victims with EC. Unfortunately, however, too few hospitals treat this as the standard of care.[14] In fact, a nationwide study found that fewer than half of all rape survivors eligible for emergency contraception actually received the treatment during a visit to a hospital emergency room.[15]
For all of these reasons, switching EC to over-the-counter status is critical to eliminating barriers to use and in improving women’s health.
II. PLAN B® MEETS FDA CRITERIA FOR OVER-THE-COUNTER DRUGS
Because Plan B® is safe, effective, and easily administered, it is suitable for non-prescription (i.e., over-the-counter) availability. Making Plan B® available over-the-counter would eliminate an unnecessary barrier to women’s access to this important contraceptive option.
A. FDA CRITERIA FOR OVER-THE-COUNTER DRUGS
To be approved by the FDA for over-the-counter distribution, a drug must meet certain criteria:
· the drug must be safe and effective;
· taking the drug must be safe enough that medical supervision – and thus, a prescription – is not necessary to preserve public health due to the drug’s toxicity, its potential for harmful side-effects, or its method of use;
· the drug must be simple enough to use that instructions on the drug’s packaging are sufficient to ensure safe and correct self-medication.[16]
The FDA requires a prescription for drugs that, because of their toxicity, their potential for harmful side-effects, or their method of use, are not safe to use except under the supervision of a medical professional.[17]
Plan B® meets the criteria for non-prescription status and can be safely marketed over-the-counter.
ECPs ARE SAFE AND EFFECTIVE
· Oral contraceptives, the same drugs found in ECPs, have been studied for over three decades. They have been studied more extensively and have been found to be safer than most drugs in medicine. No serious medical consequences from an overdose of oral contraceptives have been reported.[18]
· Plan B® can reduce a woman’s chance of becoming pregnant by up to 89 percent if taken within days of unprotected sex.[19]
ECPs HAVE MINIMAL SHORT-TERM SIDE-EFFECTS
· The most common side-effects of ECPs are nausea and vomiting; other side-effects include dizziness, fatigue, and headache. These short-term side-effects are not serious and are easily manageable without medical supervision.[20] Moreover, Plan B®, as a progestin-only drug, reduces the incidence of nausea by 50 percent and vomiting by 75 percent, as compared to ECPs containing both estrogen and progestin.[21]
· Long-term side-effects are unlikely given the very short duration of treatment.[22]
· Use of ECPs is less dangerous than pregnancy.[23]
ECPs ARE EASY AND SAFE TO SELF-ADMINISTER
· In a study of Scottish women who were given an advance supply of ECPs to keep at home, 98 percent of the women who used ECPs used them correctly, and none experienced serious adverse effects.[24]
· Women can diagnose their own need for ECPs; taking the drug involves simply swallowing pills.[25]
· The dosage and timing of ECP use are the same regardless of the individual characteristics of the woman.[26]
· No specific medical conditions preclude a woman’s use of ECPs. In fact, the only contraindication to ECPs is pregnancy – not because ECPs can harm a pregnant woman or a developing embryo, but because ECPs will not work once pregnancy begins.[27]
NON-PRESCRIPTION ACCESS TO EC DOES NOT DISCOURAGE ONGOING CONTRACEPTIVE USE
· Claims that increased access to emergency contraception might encourage riskier sexual behavior or lead to less frequent use of other forms of contraception have not been supported by recent data. A Scotland study found that, compared to women who had to go through their doctors to obtain EC, women who had a supply of ECPs available at home did not differ in their use of other forms of contraception and were not more likely to use EC more frequently. In addition, 98 percent of the women reported that they did not take more risks as a result of having EC readily available.[28]
LEADING MEDICAL GROUPS SUPPORT OVER-THE-COUNTER ACCESS TO ECPs
· The American Medical Association (AMA) supports increased access to ECPs. And, the AMA’s Council on Medical Service has stated, over-the-counter access to ECPs is especially critical for “the large number of women who have limited access to health care services, who are uninsured, and who have no established relationship with a physician. For these women, having emergency contraception available over-the-counter may be the most appropriate way for them to have adequate access to the pills.”[29]
· In February 2001, more than 70 organizations, including the American Nurses Association, the American Academy of Pediatrics, the American Public Health Association, and the Association of Reproductive Health Professionals, filed a citizen’s petition to request that the FDA switch certain emergency contraceptive pill products from prescription to over-the-counter status, arguing that “limiting EC to prescription dispensing is not necessary for the protection of public health.”[30]
CONCLUSION
In short, ECPs have all of the characteristics of an over-the-counter drug: emergency contraception pills are safe, effective, and simple to use; they are not associated with any serious or harmful side-effects; they are not dangerous to women with particular medical conditions; and their use 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 one of the most promising avenues for reducing this country’s high rate of unintended pregnancy. If women saw ECPs in pharmacies, awareness of ECPs 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 ECPs available over-the-counter would remove this barrier to access and help to improve women’s health. NARAL Pro-Choice America and our co-signers therefore urge the FDA to approve the application to switch Plan B® from prescription-only to over-the-counter status.
Respectfully Submitted,
Kate Michelman
President
NARAL Pro-Choice America
NARAL Pro-Choice America Page 5
Notes:
NARAL Pro-Choice America Page 5
[(]* NARAL Pro-Choice California, NARAL Pro-Choice Colorado, NARAL Pro-Choice Connecticut, NARAL Pro-Choice Georgia, NARAL Pro-Choice Maryland, NARAL Pro-Choice Massachusetts, MARAL Pro-Choice Michigan, NARAL Pro-Choice Minnesota, Missouri NARAL, NARAL Pro-Choice Montana, NARAL of New Hampshire, NARAL Pro-Choice New Mexico, NARAL Pro-Choice New York, NARAL Pro-Choice Ohio, NARAL Pro-Choice Oregon, NARAL Pennsylvania, NARAL Pro-Choice South Dakota, TARAL, NARAL Pro-Choice Virginia, NARAL Pro-Choice Washington, NARAL Pro-Choice Wisconsin, and Wyoming NARAL.
[1] Press Release, Women’s Capital Corporation, A New Generation of Emergency Contraception Has Arrived (July 28, 1999) (on file with NARAL Pro-Choice America). While labels for FDA-approved ECPs indicate that they should be used within 72 hours after unprotected sex, recent research shows that emergency contraceptive pills can be effective up to 120 hours after sex. However, ECPs are more effective the sooner they are taken. Helena von Hertzen et al., Low Dose Mifepristone and Two Regimens of Levonorgestrel for Emergency Contraception: a WHO Multicentre Randomized Trial, 360 The Lancet 1803, 1803-10 (2002); Charlotte Ellertson et al., Extending the Time Limit for Starting the Yuzpe Regimen of Emergency Contraception to 120 Hours, 101 Obstetrics & Gynecology 1168, 1168-71 (2003); Gilda Piaggio et al., Timing of Emergency Contraception with Levonorgestrel or the Yuzpe Regimen 353 The Lancet 721 (1999).
[2] Robert A. Hatcher et al., Emergency Contraception: The Nation’s Best Kept Secret 29-30 (1995); American College of Obstetricians & Gynecologists (ACOG), Statement on Contraceptive Methods (July 1998).
[3] Stanley Henshaw, Unintended Pregnancy in the United States, 30 Family Planning Perspectives 24, 26 (1998).
[4] Id. at 26-27.
[5] Based on data from the 1980s, it is estimated that increased use of ECPs could reduce the number of unintended pregnancies by 1.7 million annually. James Trussell et al., Emergency Contraceptive Pills: A Simple Proposal to Reduce Unintended Pregnancies, 24 Family Planning Perspectives 269, 270 (1992).
[6] Rachel K. Jones et al., Contraceptive Use Among U.S. Women Having Abortions in 2000-2001, 34 Perspectives on Sexual and Reproductive Health 294, 300 (2002).
[7] Richard A. Grossman Bryan D. Grossman, How Frequently Is Emergency Contraception Prescribed?, 26 Family Planning Perspectives 270, 270 (1994).
[8] Committee on Unintended Pregnancy, Institute of Medicine, The Best Intentions 81 (Sarah S. Brown & Leon Eisenberg eds., 1995).
[9] Only five states – Alaska, California, Hawaii, New Mexico, and Washington – currently allow pharmacists to dispense EC without a doctor’s prescription. Alan Guttmacher Institute, State Policies in Brief: Access to Emergency Contraception (Dec. 1, 2003).
[10] Approximately 75 percent of the calls resulted in an appointment or a telephone prescription from a hotline provider; 14 percent were deemed failures; and 11 percent resulted in referrals to other providers. James Trussell et al., Access to Emergency Contraception, 95 Obstetrics & Gynecology 267, 267-70 (2000).
[11] Gilda Piaggio et al., Timing of Emergency Contraception with Levonorgestrel or the Yuzpe Regimen, 353 The Lancet 721 (1999).
[12] Felicia Stewart & James Trussell, Prevention of Pregnancy Resulting from Rape: A Neglected Preventive Health Measure, 19 American Journal of Preventive Medicine 228, 228 (2000).
[13] Id. at 229.
[14] Only four states – California, New Mexico, New York, and Washington – have laws explicitly requiring hospitals to provide rape survivors with information about and access to EC. Cal. Penal Code § 13823.11; N.M. Stat. Ann. § 24-10D-3; N.Y. Public Health Law § 2805-p (effective Jan. 28, 2004); Wash. Rev. Code Ann. § 70.41.350.
[15] Annette Amey & David Bishai, Measuring the Quality of Medical Care for Women Who Experience Sexual Assault with Data from the National Hospital Ambulatory Medical Care Survey, 39 Annals of Emergency Medicine 631, 636 (2002).