December 5, 2003

Dr. Linda C. Guidice, Chair, Reproductive Health Drugs Advisory Committee
Dr. Louis R. Cantilena, Jr., Chair, Nonprescription Drugs Advisory Committee
Division of Dockets Managements (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

Re: Docket number 01P-0075-“Switch Status of Emergency Contraceptive from Rx to OTC”

Dear Drs. Guidice and Cantilena:

Planned Parenthood Federation of America (“PPFA”), the nation’s oldest and most trusted voluntary reproductive health care organization, respectfully submits these comments to voice our enthusiastic support of the supplement to the new drug application filed by Women's Capital Corporation (WCC) on April 21, 2003 to make Plan B emergency contraception available over-the-counter.

As explained more fully below, Plan B meets all existing Food and Drug Administration (FDA) criteria for over-the-counter designation. Numerous rigorous studies published in peer-reviewed medical journals attest to the drug’s efficacy, safety, and ease of use. Additionally, there is an enormous need in the United States for an easily obtained, easy to use, postcoital backup method of contraception. Widespread, unhampered availability of this product will contribute greatly to a reduction in our nation’s unacceptably high rate of unintended pregnancies and reduce the need for abortion.

Accordingly, and in light of Plan B’s strong record of efficacy and safety, and the nation’s commitment to reducing unintended pregnancy, the FDA’s Reproductive Health Drugs Advisory Committee and Nonprescription Drugs Advisory Committee should support the application submitted by WCC and allow this product to be available over-the-counter.

Plan B is Effective
Approved in July 1999, Plan B is the first and only progestin-only emergency contraceptive product to be approved by the FDA. It is used to prevent pregnancy after unprotected sexual intercourse or a contraceptive failure. The U.S. Guide to Clinical Preventive Services identifies postcoital administration of emergency contraceptive pills (ECPs) after unprotected intercourse as an effective means of reducing subsequent pregnancy(1).

Studies have shown that progestin-only methods of emergency contraception such as Plan B are effective up to 72 hours after unprotected intercourse (2, 3). To obtain optimal efficacy, the first tablet should be taken as soon as possible after unprotected intercourse or contraceptive failure; the second tablet must be taken 12 hours later. ECPs are less effective than the most popular precoital methods of contraception and are therefore not intended to for use in place of a regular method of contraception (4, 5).

Plan B can reduce the risk of pregnancy by 89 percent (from approximately 8 percent to 1 percent) when used correctly and in accordance with product labeling. When initiated within 24 hours after a single act of unprotected intercourse, Plan B can prevent 95 percent of expected pregnancies (6).

Plan B is Safe
Although the Plan B dedicated emergency contraceptive product was approved by the FDA in 1999, emergency contraception has been available for more than 25 years. Millions of women around the world have used ECPs safely and effectively (7, 8).

There are no known contraindications to the use of Plan B. It involves only the sporadic use of hormones; the rare complications that can be seen with long term use of hormonal contraception (cardiovascular and cerebrovascular events such as venous thromboembolism, pulmonary embolism, stroke, myocardial infarction) are not seen with this progestin-only method. A recent review of the scientific literature revealed no case reports with the progestin-only method (9).

In addition to the absence of contraindications, ECPs are not abortifacients. Because they are taken prior to implantation, there is no established pregnancy to disrupt. Furthermore, ECPs will not dislodge a pregnancy established prior to the act of unprotected intercourse for which the drug is taken (10). Additionally, because ECPs are not teratogenic (11), ingestion would not harm a developing fetus if taken inadvertently after pregnancy has been established.

Finally, among women who have utilized emergency contraception, most report high levels of satisfaction. A recent study of 235 women who had used ECPs found that the overwhelming majority — 91 percent — were satisfied with the method, and 97 percent would recommend it to friends and family (12). Every woman who needs emergency contraception can safely use ECPs. Even women with contraindications to the ongoing use of oral contraceptives may use them (13, 14).

This undeniably strong record of efficacy and safety, coupled with the tremendous need for improved access (described below) has led both the American Medical Association and the American College of Obstetricians and Gynecologists (ACOG) to publish positions supporting over-the-counter availability of ECPs (15, 16).

Plan B Meets All Existing FDA Criteria for Over-The-Counter Designation
The FDA’s Center for Drug Evaluation and Research (CDER) oversees all drugs, including both prescription and nonprescription drugs. In order for a drug to receive over-the-counter designation, the benefits must outweigh the risks, there must be minimal potential for misuse and abuse, consumers must be able to use it for a self-diagnosed condition, and a health care provider cannot be needed for safe and effective use. CDER also ensures that all drugs are appropriately labeled.

Plan B emergency contraceptive pills satisfy easily these parameters. The product is safe and effective, drug dosage is consistent across populations, there are no known contraindications to use, there is no potential for addiction, and the reason for drug selection is self-diagnosable. Although requirements for over-the-counter designation vary across nations, it is worth noting that ECPs are already available without a prescription in over 25 countries (17).

Need for Unhampered Access to Plan B
Unintended Pregnancy in the United States
Among developed nations, the United States has one of the highest rates of unintended pregnancy. Nearly one half of the 6.3 million annual pregnancies in this country are unintended (18). Forty-two million, or seven in 10 women of reproductive age, are sexually active and do not want to become pregnant (19). Eighty percent of teen pregnancies are unintended, and each year, nearly one in 10 young women aged 15-19 become pregnant. Fifty-three percent of unintended pregnancies in this country occur among women using contraceptives (20). Unintended pregnancies result in 1.4 million abortions and 1.2 million births every year (21).

Although the reasons for our unacceptably high rate of unintended pregnancy are many and complex, virtually everyone recognizes the need to reduce unintended pregnancies. In light of the significant costs and consequences associated with this public health concern, Healthy People 2010, the nation’s prevention agenda that identifies the most significant preventable threats to health, includes among its goals increasing to 70% the pregnancies that are intended (22).

To achieve this laudable goal, we must effect a reduction in unintended pregnancies. This will involve necessarily reducing the proportion of females experiencing pregnancy despite use of a reversible contraceptive method, increasing contraceptive use, reducing pregnancies among adolescent females, and increasing the use of emergency contraception.

Urgent Needs Unmet
Widespread use of emergency contraception could prevent an estimated 1.7 million unintended pregnancies and 800,000 abortions each year (23, 24). Despite this tremendous need, postcoital emergency contraception is not widely available to the public.

Women experience multiple barriers when attempting to access emergency contraception. These include widespread lack of knowledge about ECPs among both women and providers (25), limited office hours at health care facilities and physicians’ offices, providers’ refusal to prescribe ECPs, pharmacists’ refusal to dispense ECPs, and lack of availability at many pharmacies. Although numerous campaigns designed to increase awareness of ECPs among both the public and health care providers have been undertaken, the above statistic attests to a significant unmet need.

Even if women are able to obtain the required prescription for ECPs, regrettably, surveys, anecdotal stories, and published studies all point to the persistence of barriers they experience in obtaining the product from a pharmacy. Although in several states there are initiatives underway by which women can access ECPs directly from a pharmacist (see below), there are numerous reports of pharmacists objecting to ECPs based on their personal beliefs and thus refusing to stock and/or dispense the product. One survey of pharmacists in Pennsylvania revealed that only 35% of pharmacists stocked ECPs. Furthermore, among pharmacists who were unable to dispense ECPs on the day of request, six percent stated dispensing ECPs was against store policy and seven percent stated that ECPs conflicted with personal beliefs (26).

Victims of sexual assault also stand to benefit from over-the-counter availability of emergency contraception. Each year, more than 330,000 rapes and sexual assaults are reported by women in the United States. An estimated 25,000 of these rapes result in pregnancy. Nearly 22,000 of these resultant pregnancies could be prevented by timely initiation of emergency contraception (27). Unhampered access is particularly critical for this cohort since many hospital emergency departments, particularly those in religiously-affiliated hospitals, refuse to either dispense ECPs or refer woman elsewhere for provision. Indeed, many hospitals refuse to provide any information on emergency contraception to rape victims.

Opponents of expanded access believe erroneously that more widespread availability will result in over-reliance on ECPs as a contraceptive method and women will abandon more effective precoital birth control methods. Current barriers, however, serve only to deny access to a drug whose efficacy is enhanced by timely initiation of the regimen. Numerous studies show that women turn to ECPs only in emergencies — as a backup to their usual birth control method. Improving access to emergency contraception does not increase women's reliance on it as a primary method of birth control or lead to method abuse (28, 29, 30, 31). In one study, many women stated their experience with ECPs increased their regular contraceptive method use: they did not want to experience another contraceptive mishap (32). In another study, improved regular contraceptive use was seen at one-year follow-up (33). Furthermore, these women also reported that they did not intend to substitute ECPs for regular contraceptive use (34).

Efforts to Improve Access Emergency Contraception Fall Short
Numerous initiatives have attempted to overcome the barriers enumerated above. These include providing women with either ECPs or a prescription for ECPs in advance of need (advance provision), collaborative practice agreements between pharmacists and physicians in select states, and PPFA’s dedicated efforts to enhance utilization of ECPs. Despite these well-intentioned efforts, though, access remains problematic.

Advance Provision
Studies show that women provided with ECPs in advance of a contraceptive failure or unprotected intercourse used other birth control methods at the same rate as women who were not provided with the pills in advance of need. The former women were more likely to use emergency contraception once and were not more likely to use it repeatedly. Ninety-eight percent of the time, women used the method correctly, and the experienced fewer unintended pregnancies than those who did not have ECPs at home (35). A more recent study investigating advance provision of ECPs to adolescents had similar findings: teenagers were more likely to use ECPs and, importantly, their use of condoms did not decrease with advance provision (36).

These studies counter predictions of reduced adherence to precoital contraceptive methods and support efforts to designate Plan B as a nonprescription drug. Furthermore, in terms of initiatives aimed at expanding access to ECPs, however, these studies do not assess the long-term impact on provider prescribing patterns. The ACOG notes that only 20 percent of ob-gyns report that they include ECPs as part of their routine contraceptive counseling. It is therefore likely, unfortunately, that such initiatives have had limited success (37).

Collaborative Practice Agreements
Five states have enacted laws that enable women to obtain ECPs directly from pharmacists without first obtaining a prescription from their health care provider. In these arrangements, pharmacists work in a collaborative practice agreement with a licensed physician. The states that have undertaken these initiatives include Alaska, California, Hawaii, New Mexico, and Washington.

At this time, limited data are available regarding the impact of these initiatives. A recent study published in the November issue of the Journal of Obstetrics and Gynecology revealed that, despite the collaborative practice initiative, many retail pharmacies in the Albuquerque metropolitan area do not stock ECPs because of a lack of perceived need (38).

Planned Parenthood’s Efforts
Planned Parenthood is a leading provider of emergency contraception in the U.S. As awareness of ECPs grows, Planned Parenthood affiliates have experienced a concomitant increase in demand. The number of women receiving ECPs from Planned Parenthood clinics has grown from roughly 17,000 in 1995 to 633,756 in 2002 (39).

Since dedicated ECP products became available in 1998, Planned Parenthood affiliates have undertaken several initiatives designed to help women overcome barriers. Women can now obtain ECPs via face-to-face encounters with a health care provider, including advance provision; via telephone; or, in certain states, on-line.

Among the Planned Parenthood affiliates offering emergency contraception without a face-to-face encounter, a general standardized process is followed. First, women are provided basic information about emergency contraception. After receiving this information, they are then asked to provide consent for treatment via the on-line/telephone process. This is followed by a brief health questionnaire to assess the last menstrual period, with appropriate follow-up questions as necessary. This information is reviewed by a health care professional and a prescription for ECPs is forwarded to a local pharmacy.

Although these efforts have resulted in significant increases in the sale of emergency contraceptive kits, most clinics are not open, and on-line and telephone requests cannot be processed, during the periods of greatest need: weekends. Women experiencing either a contraceptive failure or unprotected intercourse on a Friday evening, for example, must often wait until Monday morning to see a health care provider to obtain the necessary prescription for ECPs. And though a woman may be able to place an order on-line or leave a telephone message, her request will not be reviewed, and a prescription cannot be issued, until the clinic is again open for business. Once the prescription is obtained, she must then find a pharmacist that will dispense the drug, as well as a pharmacy that stocks it. In this all-to-frequent scenario, a significant delay to initiation of the ECP regimen has occurred, and the efficacy of the drug is inevitably reduced. Over-the-counter availability of Plan B will allow women to obtain ECPs and initiate the regimen as soon as possible after unprotected intercourse or contraceptive failure.

Nonprescription Plan B: Fulfilling the Promise
Nonprescription availability of Plan B will undoubtedly increase access to emergency contraception. Over-the-counter availability will reduce time and cost barriers associated with a clinic visit, and will all but eliminate the potential for “conscience-related” refusals. Over-the-counter status will also enhance the likelihood of more timely initiation of the method, thus increasing its efficacy (40).

In light of emergency contraception's history of safety and efficacy, and our experience as the largest reproductive health provider of ECPs, the Planned Parenthood Federation of America strongly supports making Plan B available to women without a prescription. We believe this is the most effective way to broadly increase access to emergency contraception and consequently decrease unintended pregnancies and abortions in the United States. Accordingly, we look forward to a positive review by the FDA’s Nonprescription Drugs and Reproductive Health Drugs advisory committees, and eagerly await the day when women in the United States can more readily access this important safe, effective, and easy-to-use drug.

Sincerely,
Vanessa Cullins, MD, MPH, MBA
Vice President, Medical Affairs
Planned Parenthood Federation of America, Inc.

1 HHS. Guide to Clinical Preventive Services. 2nd ed. Washington, DC: HHS, 1995.
2 Rodrigues, Isabel, et al. (2001). "Effectiveness of Emergency Contraceptive Pills Between 72 and 120 Hours After Unprotected Sexual Intercourse." American Journal of Obstetrics and Gynecology, 184(4), 531-537
3 Van Look, Paul F.A. & Felicia Stewart. (1998). "Emergency Contraception." Pp. 277-295 in Robert A. Hatcher et al., eds., Contraceptive Technology, 17th edition. New York: Ardent Media.
4 op cit Rodrigues, Isabel, et al.
5 op cit Van Look, Paul F.A. & Felicia Stewart.
6 Task Force on Postovulatory Methods of Fertility Regulation. (1998). “Randomised Controlled Trial of Levonorgestrel Versus the Yuzpe Regimen of Combined Oral Contraceptives for Emergency Contraception.” The Lancet, 352(9126). 428–433.
7 Glasier, Anna. (1997). "Drug Therapy: Emergency Postcoital Contraception." New England Journal of Medicine, 339(15), 1058-1064.
8 Guillebaud, John. (1998). "Commentary: Time for Emergency Contraception with Levonorgestrel Alone." The Lancet, 352(9126), p. 416.
9 Westhoff C. (2003). “Emergency Contraception.” New England Journal of Medicine, 349,1830-1835.
10 ibid.
11 ibid.
12 Harvey, S. Marie, et al. (1999). "Women's Experience and Satisfaction with Emergency Contraception." Family Planning Perspectives, 31(5), 237-240 & 260.
13 op cit Guillebaud, John.
14 op cit Van Look, Paul F.A. & Felicia Stewart.
15 Branom M. (2000, December 5). “Better access to morning-after pill urged.” Associated Press.
16 American College of Obstetricians and Gynecologists (ACOG). (2001, February 14). Statement of the American College of Obstetricians and Gynecologists supporting the availability of over-the-counter emergency contraception, news release, Washington, DC: ACOG.
17 Gainer E, Blum J, Toverud EL, Portugal N, Tyden T, Nesheim BI, et al. (2003). “Bringing emergency contraception over the counter: experiences of nonprescription users in France, Norway, Sweden and Portugal.” Contraception, 68:117-124.
18 Henshaw SK. (1998). “Unintended pregnancy in the United States.” Family Planning Perspectives, 30:24-9.
19 Boonstra, Heather. (2002, February). “Teen Pregnancy: Trends and Lessons Learned.” The Guttmacher Report on Public Policy, 7–10.
20 The Alan Guttmacher Institute. (2000). Fulfilling the Promise: Public Policy and U.S. Family Planning Clinics. New York: Alan Guttmacher Institute.
21 ibid.
22 U.S. Department of Health and Human Services. (2000, November). Healthy People 2010.
23 Glasier, Anna & David Baird. (1998). "The Effects of Self-Administering Emergency Contraception." The New England Journal of Medicine, 339(1), 1-4.
24 op cit Van Look, Paul F.A. & Felicia Stewart.
25 op cit Harvey, S. Marie, et al.
26 Bennett W, Petraitis C, D’Anella AD, Marcella S. (2003). “Pharmacists’ knowledge and the difficulty of obtaining emergency contraception.” Contraception, 68, 261-267.
27 Stewart FH, Trussell J. (2000). “Prevention of pregnancy resulting from rape: A neglected health measure.” American Journal of Preventive Medicine, 19(4), 228–229.
28 op cit Glasier A, Baird D.
29 Rowlands S, Lawrenson R. (2000). “Repeated use of hormonal emergency contraception by younger women in the UK.” British Journal of Family Planning, 26, 138-143.
30 Roizen J, Garside R, Barnett L. (2001). “Repeat Use of Emergency Contraception: How Frequent Is It?” Journal of Family Planning and Reproductive Health Care, 27(4), 197-202.
31 Jackson RA, Schwarz EB, Freedman L, Darney P. (2003). “Advance Supply of Emergency Contraception: Effect on Use and Usual Contraception.” Obstetrics and Gynecology, 102(1), 8-16.
32 Gainer E, Blum J, Toverud EL, Portugal N, Tyden T, Nesheim BI, et al. (2003). “Bringing emergency contraception over the counter: experiences of nonprescription users in France, Norway, Sweden and Portugal.” Contraception 2003;68:117-124.
33 op cit Jackson RA, Schwarz EB, Freedman L, Darney P.
34 op cit Harvey, S. Marie, et al.
35 op cit Glasier A, Baird D.
36 Roye, Carol & Jennifer Johnsen. (2001). "Routine Provision of Emergency Contraception to Teens and Subsequent Condom Use: A Preliminary Study." Journal of Adolescent Health, 28(3), 165-166.
37 American College of Obstetricians and Gynecologists (ACOG). (2001, April 30). “New ACOG Leader Promotes Widespread Advance Prescriptions for Emergency Contraception.” [Online]. http://www.acog.org/from_home/publications/press_releases/nr04-30-01-1.cfm
38 Espey, Eve, et. al. (2003). “Emergency Contraception: Pharmacy Access in Albuquerque, New Mexico.” Obstetrics and Gynecology, 102(5),918-921.
39 Planned Parenthood Federation of America, (1996; 2003). Annual Reports.
40 op cit Gainer E, Blum J, Toverud EL, Portugal N, Tyden T, Nesheim BI, et al.