The U.S. Food and Drug Administration (FDA) is dealing with the aftermath of what could be one of its most controversial decisions impacting women's health and reproductive rights. A switch to over-the-counter status from prescription-only use for Emergency Contraception had been expected in February. On May 6, 2005, in a move that disregarded the opinion of the doctors and scientists on two advisory boards, the drug Levonorgestrel an emergency contraceptive (EC), sold under the brand name Plan B, was not approved for over-the-counter sale. This went against the advice of a 23 to 4 vote in favor of making the drug more accessible to the women who need it to prevent unintended pregnancies.1 Director of the Office of Women's Health and the FDA Commissioner have resigned from positions at the FDA in protest. "I can no longer serve as staff when scientific and clinical evidence, fully evaluated and recommended for approval by the professional staff here, has been overruled." said Dr. Susan F. Wood, in announcing her resignation.2
The battle over emergency contraception began in February of 2001, when over 70 medical and public health organizations filed a petition with the FDA to make Plan B available over-the-counter. The FDA approved EC for prescription use in 1999.3 With a prescription from her doctor, a woman could gain access to this method of pregnancy prevention in the event of unprotected sex, the failure or improper use of a birth control method, or when a sexual assault had occurred. It works best when taken within 24 hours after unprotected sex, but can be used successfully up to 72 hours after sex.4 It is often mistakenly called "the morning after pill", but it is not one pill, and it can be taken effectively beyond the "morning after". Over 95% of the women who take EC do not become pregnant.5 EC contains the same medications that are in regular birth control pills and it sometimes causes side effects such as nausea, fatigue, dizziness or vomiting, but does not impair a woman's ability to get pregnant in the future. EC can not terminate a pregnancy. It is not Mifepristone (RU 486), which works after a fertilized egg has attached to the uterine wall and ends a pregnancy. EC works by preventing an egg from being released (ovulation), preventing fertilization of the egg, or by preventing a fertilized egg from implanting in the uterine lining.6
As a matter of reproductive justice it is imperative that women control their bodies, including when to become pregnant, give birth, or parent children. Access to EC is a critical part of the struggle for reproductive justice. Unintended pregnancy has a tremendous impact on the lives of all women, including Black women and teenagers. Family planning is critical to physical, mental, and economic health of our communities. Lack of access to pregnancy options and prenatal care often puts Black women, and especially young mothers, in jeopardy. Over-the-counter access to EC as a part of comprehensive reproductive justice and healthcare for Black women could greatly reduce the number of unintended pregnancies and abortions.7
EC is also part of the coordinated care and healing for many survivors of sexual abuse and assault. Due to its effectiveness at preventing pregnancy after sexual intercourse, EC can be a tremendous relief to women and teens who have been forced or coerced into sex. It is also helpful when a regular method of birth control fails or is used improperly.8 This gives women more options to make educated healthcare decisions.
Emergency Contraception's effectiveness is time-sensitive. As sexual encounters and assaults may occur on weekends, this makes seeing a doctor, receiving and filling a prescription, and beginning to take the dosage within the 72 hour window very difficult. For many Black women and girls who are uninsured and underinsured, waiting to see a healthcare provider to get a prescription for EC within this time period is not an option. Waiting times at free or low-cost clinics and even HMOs can be days, if not weeks, rendering EC ineffective. Black women also have the high rates of sexual assault, but low rates of reporting, meaning that they will not benefit from the EC offered during a rape exam when a sexual assault is reported to police. 9 Due to the stigma (and blaming of survivors) that surrounds sexual assault, as well as the distrust of authorities, sexual violence is underreported by Black women.10 These survivors struggle in silence, and without prompt, over-the-counter access to EC, possibly with the added burden of an unintended pregnancy from the assault.
In the FDA's rare move, overriding the recommendations of its professional staff, to issue a "not approvable" letter to Barr Laboratories (the makers of Plan B), they cited concerns about its effects on young women's health and behavior. Opponents of making EC available over-the-counter have expressed similar concerns. They argue that access to Plan B will encourage adolescent sexual promiscuity and sexual risk-taking, despite evidence that this has not been the case when emergency contraception is made easily available to young people.11 The World Health Organization and the FDA's own doctors stated that this concern was unwarranted. Studies have shown that when EC is accessible, adolescent girls and adult women do not : 1) abandon their regular use of contraception, 2) have more unprotected sex, 3) decrease their use of condoms or 4) become repeat EC users.12
In direct response to the rejection, Barr Laboratories submitted a revised "dual label status" proposal that would make Plan B available without a prescription only to women over 16 years of age. Women 15 and younger would continue to need a prescription to obtain EC. The FDA failed to respond to this modified proposal. Even with pressure from physicians, over 50 members of congress, and women's health and reproductive rights advocates, the FDA has continually failed to meet its own deadline for issuing a decision on Plan B.
Reports have surfaced that a conservative member of the FDA Reproductive Health Drug Advisory Committee submitted a minority opinion in support of a vote against over-the-counter status for Plan B.13 An editorial published in the New England Journal of Medicine echoes concerns that the FDA's decision is being influenced by politics. "The recent decision by the FDA...suggests that the decision-making process is being influenced by political considerations...A treatment of any other condition, from hangnail to headache to heart disease, with a similar record of safety and efficacy would be approved quickly."14
Recently, the FDA has indefinitely deferred a decision, prompting the resignation of Dr. Wood and FDA Commissioner Lester Crawford, after only 2 months as Commissioner. Just this month, the Government Accountability Office released a report finding the decision not to approve Plan B for over-the-counter use highly unusual, made with atypical involvement from high-level agency officials, and likely to be made months before the formal announcement.15
Representatives Maloney, Shays, Inslee, and Crowley have introduced "Plan B for Plan B Act of 2005." This Bill requires the FDA to make a decision on Plan B.16
Access to care and education about our reproductive health can be life-changing and life-saving. Women have been waiting for more than two years for the FDA to decide whether they can have access to emergency contraception that could prevent unintended pregnancies and reduce the need for abortion. The FDA's own experts and scientists have overwhelmingly recommended giving women over-the-counter access.17 The American Academy of Pediatrics has urged its members to "help ensure that all adolescents have knowledge of and access to contraception, including barrier methods and EC supplies".18 More than 70 professional medical and public health associations including the American Medical Association, the American College of Obstetricians and Gynecologists and the Society for Adolescent Medicine have endorsed EC access for women of all ages. Reproductive justice for Black women and girls must include every option.
1. Sexuality Information and Education Council of the United States, "Politics or Science? FDA Denies Emergency Contraception Over-the-Counter Application", www.siecus.org/policy
2, Los Angeles Times, September 6, 2005
3. Office of Congresswoman Carolyn Maloney, "Plan B Timeline"
4. U.S. Department of Health and Human Services, WomensHealth.gov, www.4woman.gov
5. "What is EC", Emergency Contraceptive Help, www.ec-help.org
6. U.S. Department of Health and Human Services, WomensHealth.gov, www.4woman.gov
7. International Consortium on Emergency Contraception, www.cecinfo.org
8. "What is EC", Emergency Contraceptive Help, www.ec-help.org
9. "Women of Color and Sexual Assault", New York Coalition Against Sexual Assault, www.nyscasa.org
10. Africana Voices Against Violence, www.tufts.edu
11. Sexuality Information and Education Council of the United States, "Politics or Science? FDA Denies Emergency Contraception Over-the-Counter Application", www.siecus.org/policy
12. Glasier and Baird, 1998, International Consortium on Emergency Contraception
13. Office of Congresswoman Carolyn Maloney, "Plan B Timeline"
14. "Slaughter Calls on President Bush to Fire Leadership at FDA for Controversial EmergencyContraception Decision, June 3, 2004, www.siecus.org
15. NARAL, Pro-Choice America, www.prochoiceamerica.org, Congresswoman Maloney
16. Office of Congresswomen Carolyn Maloney, "Plan B Timeline"
17. NARAL, Pro-Choice America, www.prochoiceamerica.org
18. NARAL, Pro-Choice America, www.prochoiceamerica.org