Emergency Contraception: the science and politics driving the debate.

Emergency Contraception (EC) refers to any type of birth control method used after intercourse to prevent pregnancy. The two possible methods are the emergency insertion of an Intrauterine Device (IUD) or the administration of emergency contraception pills. Emergency insertion of an IUD is rare in the United States, and, therefore, the scientific and political debates in the U.S. center only around the use of emergency contraceptive pills, sometimes referred to as the "morning after pill." For the purpose of this article EC will refer solely to these pills.

EC is a high dose of regular birth control pills that can be taken within 120 hours (five days) of unprotected intercourse as a back up method of birth control if a woman did not use a regular method or if her regular method failed (e.g. the condom broke). When taken within 72 hours of unprotected intercourse, EC can reduce a woman's chance of becoming pregnant by 80 to 85%. It is most effective if taken within the first 12 to 24 hours of unprotected sex. (1) EC does not protect against sexually transmitted diseases, including HIV.

EC has been the subject of heated debate in the United States for several decades. Unfortunately, conservative far right organizations have made this debate not about women's health but about abortion, sexual activity, and the restriction of healthcare choices for women. Three issues remain at the center of this debate: 1) whether EC is an abortifacient; 2) whether this back-up method of birth control discourages the use of regular methods of birth control; and 3) whether emergency contraception increases sexual activity. This article is designed to explore these issues and provide some political and historical context to the debate around emergency contraception.

HISTORY OF EMERGENCY CONTRACEPTION

The practice of using oral birth control pills after unprotected sex has been in place since the 1960s. The first such documented case was published in the mid-1960s when physicians in the Netherlands administered postcoital estrogen to prevent pregnancy in the victim of a sexual assault. (2) In 1984, the United Kingdom became the first country to approve a product specifically packaged as EC and today, dedicated products are registered in over 80 countries worldwide. (3)

Beginning in the 1970s, physicians in the United States prescribed a similar method through "off-label" use of oral birth control pills, a common and legal practice. (4) Nonetheless, official approval by the Food and Drug Administration (FDA) was still decades off.

Advocates and physicians wanted the regimen to be formally approved by the FDA so that there would be the possibility of greater access and increased awareness among women. This process began in November 1994 when the Center for Reproductive Rights, formerly known as the Center for Reproductive Law and Policy, attempted to force the FDA's hand, and filed a citizen petition with the FDA on behalf of a coalition of leading medical and public health groups. The petition requested that the FDA require manufacturers of birth control pills to include information about EC in the product packaging of certain brands. (5) Although the FDA declined the petition and, in doing so, declined to require the relabeling of these products as emergency contraception, the agency took an unusual step and unanimously declared, in June 1996, that emergency contraceptive pills are a safe and effective way to prevent pregnancy if taken in the recommended dosages up to 72 hours after unprotected intercourse.

FDA Approval

Shortly thereafter, in February 1997, the FDA officially declared regimens of commonly used oral birth control pills as safe and effective for use as emergency contraception to prevent pregnancy. The FDA published dosage information for six brands of oral contraception in an effort to "encourage manufacturers to make this additional contraceptive option available." The FDA stated that it would accept applications to manufacture and market EC without requiring new drug trials as the safety and efficacy of EC had already been demonstrated. (6) It noted that "... similar regimens have been used extensively in the United States in the last two decades, even though no products are approved and labeled for this use." (7) Given these circumstances, it is no wonder that, in certain circles, emergency contraception was for years known as "the nation's best-kept secret."

Manufacturers took the FDA up on its offer and in September 1998, the FDA approved an application from Gynetics, Inc. to market the Preven Emergency Contraception Kit, the first official emergency contraception regimen in the United States. The Preven Kit contained the Yuzpe regimen of emergency contraception pills, named for Canadian physician Albert Yuzpe who, in 1974, published early studies demonstrating the safety and efficacy of EC. (9) Though Preven is no longer being manufactured, limited supplies still exist and are still considered safe and effective.

Less than a year later, in July 1999, the FDA approved a second EC product, Plan B, which contains only one hormone, the progestin levonorgestrel. A World Health Organization-supported study found this to be more effective and have fewer side effects than the earlier approved regimen.

Over-the-Counter Status

The FDA approval of Preven and Plan B was hailed by advocates and doctors alike, yet many felt that EC should be even more widely available through over-the-counter (OTC) pharmacy access. Women in 37 countries, including Albania, Belgium, Canada, Denmark, Israel, Morocco, Portugal, South Africa, Sweden, and the United Kingdom can obtain EC without a prescription. (10) However, the campaign for OTC status in the United States has been slowed by anti-choice and anti-family planning organizations that have launched misinformation campaigns about the safety and efficacy of EC.

In February 2001, the Center for Reproductive Rights filed a petition with the FDA on behalf of more than 70 medical, public health, and other organizations, including SIECUS, to grant over-the-counter status for EC. No decision was ever issued for this petition. (11) Efforts continued in April 2003 when the Women's Capital Corporation, the former producer of Plan B (which has since been acquired by Barr Laboratories), submitted an application to the FDA to switch Plan B from prescription-only to OTC status. The first decision in a string of many to be made on this application was handed down in December 2003 when a joint FDA advisory panel comprised of the Reproductive Health Drugs and Nonprescription Drugs Advisory Committees voted overwhelmingly, 23-4, in favor of making EC available over the counter, without a prescription.

POLITICS TAKES OVER

Despite this overwhelming support for granting over-the-counter status, the issue remains unresolved almost two years later. These past two years have been characterized by misinformation campaigns, stall tactics, and political maneuvers.

Misinformation Campaigns

The most common misconception about EC is that this method of birth control is an abortifacient--a method of abortion. Although many people view emergency contraception and medical abortion as similar, in reality EC only works to prevent pregnancy and does not terminate a pregnancy. Anti-choice organizations continue to mislead the public and argue that EC causes an abortion despite the fact that this is in direct contradiction to the scientific literature and opinions of mainstream health organizations.

According to generally accepted definitions of pregnancy, put forth by public health entities such as the American College of Obstetricians and Gynecologists, the National Institutes of Health, and the U.S. Department of Health and Human Services, pregnancy begins when a pre-embryo completes implantation into the lining of the uterus. (12) Originally there was some ambiguity as to how exactly EC prevented pregnancy--it was unclear whether it suppressed ovulation thereby preventing fertilization or whether it worked after fertilization by preventing a fertilized egg from implanting in the uterus. Recent studies, however, prove that EC works only by interfering with ovulation, thus preventing fertilization. (13) [See Population Council article on p. 20] In fact, there is no evidence that EC prevents implantation, alters sperm or egg transport, inhibits fertilization, or changes cervical mucous.

Attempts to prevent the granting of OTC status to EC have also focused on whether EC decreases use of regular birth control methods or increases sexual activity, especially among adolescents.

In January 2004, 49 members of Congress, led by anti-choice and anti-family planning advocate Representative Dave Weldon (R-FL), sent a letter to President Bush expressing concern with adolescent use of EC and charging that the FDA panel did not consider the impact that over-the-counter availability may have on the sexual health of young people. The letter stated that, "we are very concerned that no data is available to suggest what impact this decision will have on the sexual behavior of adolescents and the subsequent impact on adolescent sexual health. We are concerned that adolescent exposure to sexually transmitted infection will increase because of the availability of [Plan B] over-the-counter. This availability may ultimately result in significant increases in cancer, infertility and HIV/AIDS." (14)

In reality, the FDA panel had considered over 15,000 pages of data from approximately 40 studies showing that making Plan B available over the counter was safe and effective for all women of reproductive age. In particular, the application included the results of eight behavioral studies, whose sample sizes ranged from 160 to 1,000 women ages 15-45. These eight studies compared women who had been provided with EC regimen in advance of needing it with others who had been provided only information on this method of pregnancy prevention. They found that women who receive EC in advance are more likely to use the regimen but are not more likely to engage in unprotected sex. In addition, the studies found that these women were not more likely to be inconsistent in their use of regular contraceptives, including condoms, than women who were given only information. In fact, a three-year study of more than 20,000 women ages 16-49, found that over-the-counter availability of EC does not lead women to rely on it instead of other birth control methods.

Further, to the contrary of politicians' rhetoric that the availability of EC would lead to increased sexual activity among young women, the same study released in the British Journal of Medicine, also found that access to EC does not lead to an increase in unprotected sex. The researchers concluded that fears that non-prescription EC would alter contraceptive and sexual practices were unfounded. The report noted that, "making emergency contraception available over the counter does not seem to have led to an increase in its use, to an increase in unprotected sex, or to a decrease in the use of more reliable methods of contraception." (15) The authors concluded that, "given the apparent absence of negative consequences, and the fact that many women clearly prefer to buy [emergency contraception] over the counter, our study supports the case for lifting the ban on over-the-counter sales in the United States and other countries." (16)

Based on this research, the FDA panel was unanimous in finding that the drug was safe for use without a prescription and that there was no evidence to suggest that over-the-counter availability would lead to substitution of EC for regular use of other contraception methods. A recurring theme in the panel's discussion was that over-the-counter status of EC would increase timely access to this back-up birth control method for both adult women and teenagers, which in turn would yield significant individual and public health benefits. (17)

Stall Tactics

In February 2004, one week before the scheduled date to make its decision of whether to grant over-the-counter status to Plan B, the FDA announced that it would need an additional 90 days to complete its review of Plan B's application. While not specifically referencing the Weldon letter, the FDA stated that the 90-day extension would permit the agency to more thoroughly review the data on use by adolescents. (18) Then in early May 2004, the FDA overruled the recommendation of its own advisory panel and issued a "non-approvable" letter to Barr Laboratories, officially rejecting its application. The FDA stated that it rejected Barr's application based "primarily on the lack of data concerning OTC use of the product among adolescents younger than 16 years old. The sponsor's application contained no data in subjects under 14 years of age and very limited data in adolescents 14 to 16 years old." (19)

Steve Glason, acting director of the FDA's Center for Drug Evaluation and Research, acknowledged that the decision to reject Barr's application was far from typical but stated that he was worried that if young women had easier access to EC, some may be more likely to have sex without condoms, thereby exposing themselves to an increased risk for sexually transmitted diseases. (20) The FDA's decision was all the more unusual as evaluation of drug safety for use over-the-counter generally looks to be sure that: 1) the benefits outweigh the risks; 2) the potential for misuse and abuse is low; 3) the consumer can use it for self-diagnosed conditions; 4) it can be adequately labeled; and 5) health practitioners are not needed for the safe and effective use of the product. In keeping with this criteria, the joint advisory panel overwhelmingly found that all evaluation measures had been successfully been met. (21)

In its "non-approvable" letter to Barr Laboratories, the FDA suggested two possible options for Barr to obtain approval for marketing Plan B over the counter: 1) submitting additional data demonstrating that the drug can be used safely by women under 16 years of age without professional supervision; or 2) supplying additional information in support of a revised "dual label," which would allow the marketing of Plan B as a prescription-only product for women under the age of 16 and an over-the-counter product for women 16 and older. (22) In July 2004, Barr Laboratories submitted a response to the FDA proposing that Plan B be marketed with the "dual label" status.

In January 2005, the FDA announced that it was delaying its decision on Plan B once again simply indicating to Barr Laboratories that it would complete the review of its application in the coming months. This was in contradiction to the Prescription Drug User Fee Act which demands that the FDA make decisions on applications within ten months of the original application's submission and within six months of an amended application. (23)

In March 2005, during a Senate Health, Education, and Labor Committee (HELP) hearing, Senators Patty Murray (D-WA) and Hillary Rodham Clinton (D-NY) pressed the then-Acting Commissioner of the FDA, Lester Crawford, to answer questions about Barr Laboratories's long-pending application for nationwide over-the-counter approval of Plan B. Crawford promised during the hearing that the FDA would decide on the application "within weeks." (24) To help keep the pressure on the FDA, the two Senators placed a hold on Crawford's nomination--in effect blocking a full Senate vote on his nomination to the position of FDA Commissioner until the FDA made a decision on Barr Laboratories' application. Although Crawford had promised a decision within weeks, it was not until July 15, 2005, that Secretary of Health and Human Services, Michael Leavitt, announced that the FDA would make a decision by September 1, 2005 whether to allow the sale of EC over the counter, without a prescription for women ages 16 and older. (25) With this announcement, Senators Murray and Clinton lifted their holds on Crawford and cleared the way for the Senate to vote on his nomination as head of the FDA. On July 18th the Senate approved Crawford as FDA Commissioner, 78-16. (26)

Political Maneuvers

Despite these promises by Crawford and Leavitt, Crawford announced on August 26, 2005 that the decision would be further delayed. He explained that the agency had concerns over whether or not a product could be sold both OTC and with a prescription in the same packaging and issued an Advance Notice of Proposed Rulemaking (ANPR) to request comment on whether the FDA has the authority to approve a drug in both prescription and OTC form and whether such a limitation would be enforceable.

Five days later, on August 31, Susan F. Wood, Director of the Office of Women's Health and Assistant Commissioner for Women's Health at the FDA, resigned in protest of this decision. (27) Wood explained that this latest decision to delay the ruling was not made in the usual manner of the FDA, but instead "at the commissioner level ... where most if not all of the professional staff were excluded." (28) In her remarks to colleagues upon her resignation, Wood stated that the FDA had never previously raised questions regarding teens' use of other drugs. "I have spent the last 15 years working to ensure that science informs good health-policy decisions," Wood said. "I can no longer serve as staff when scientific and clinical evidence, fully evaluated and recommended by the professional staff here, has been overruled," she concluded. (29)

Wood's resignation was an unparalleled public show of dissension for the FDA. The media attention the resignation garnered prompted additional moves from lawmakers. Many supporters of the Plan B application for OTC status, including Senators Clinton and Murray, accused Crawford of making a political decision that ignored science and public health. "It is time for the FDA to stop playing games with the health and well-being of millions of American women," the Senators said in a joint statement. "Day by day, the public's confidence in the FDA's ability to make decisions based on scientific evidence of safety and efficacy is eroding." (30)

Senators Clinton and Murray called on Senator Michael Enzi (R-WY), the chairman of the Senate Committee on Health, Education, Labor and Pensions, to hold a hearing on the latest delay. (31) A spokesman for Senator Enzi stated that he is considering their request for a hearing, and has separately asked the FDA to explain how and why it reached this latest decision. (32) Senators Murray and Clinton have also asked the Government Accountability Office (GAO) to finally release its report on the FDA handling of Plan B, a report requested by them last summer. "This is not game over, this is game on," Murray said, adding she was not about to give up. (33) In a separate letter, four House Democrats asked President Bush to issue "a clear directive" to federal agencies that all health-related decisions are to be based on science. (34)

In a surprise move, Commissioner Crawford resigned on September 23, 2005 just two months after his confirmation. (35) During Senate hearings on the Fiscal Year 2006 Agriculture Appropriations bill, Senators Murray and Clinton issued a statement about the FDA and Crawford's leadership on the Senate floor stating that, "with the resignation of Dr. Crawford, the FDA has a real opportunity to restore its battered reputation and nominate a leader with vision and drive to ensure that the FDA upholds its gold standard of drug regulation." The senators succeeded in persuading colleagues to include language in the agency's final appropriations bill expressing congressional concern over the direction of the FDA and calling for an expedited decision on Plan B. (36)

THE NEED REMAINS

Currently, half of all pregnancies in the United States (about 3 million) are unintended, and approximately 1.3 million of these end in abortion. According to the labeling approved by the FDA itself, Plan B decreases the risk of unintended pregnancy resulting from contraceptive failure or unprotected intercourse by 89%. It is estimated that access to EC could reduce unintended pregnancies by at least 50% among American women. (37) In fact, use of EC alone prevented an estimated 51,000 abortions in 2000, suggesting that increased use of EC may have accounted for up to 43% of the total decline in abortion rates (11%) from 1994 to 2000. (38) Widespread availability of emergency contraception has the potential to reduce many of these unintended pregnancies, and dramatically reduce abortion rates in the United States.

For too many years, politics has been allowed to dictate a debate that should have been easily settled by the well-documented and unassailable scientific evidence that shows that emergency contraception is safe, effective, and desperately need. It is time for the FDA to see through the misinformation and political tactics and to allow women unfettered access to this important method of preventing unintended pregnancies.

Resources

Emergency Contraception Hotline, 1-888-NOT-2-LATE

Emergency Contraception Website, www.not-2-late.org

References

1. "Provision of emergency contraception to adolescents: Position paper of the Society for Adolescent Medicine Society for Adolescent Medicine," Journal of Adolescent Health 35 (2004): 66-70.

2. Charlotte Ellertson, "History and Efficacy of Emergency Contraception: Beyond Coca-Cola," Family Planning Perspectives 22.2 (June 1996): 44-48.

3. "Emergency Contraception: The Need to Increase Public Awareness," The Guttmacher Report 5.4 (October 2002), accessed 10 August 2005, <http://www.guttmacher.org/pubs/tgr/05/4/gr050403.html>.

4. Ibid.; "'Off-Label' and Investigational Use of Marketed Drugs, Biologics, and Medical Devices," (Washington, DC: FDA/Office of Science Coordination and Communication, 1998), accessed 10 November 2005, <http://www.fda.gov/oc/ohrt/irbs/offlabel.html>.

5. "Groups Want New Labels on Birth Control Pills," Atlanta Journal Constitution, 30 November 1994, E8.

6. "Prescription Drug Products; Certain Combined Oral Contraceptives for Use as Postcoital Emergency Contraception; Notice," Food and Drug Administration, Federal Register 62.37 (25 February 1997):8609-8612.

7. Ibid.

8. Robert A Hatcher, et al., Emergency Contraception: The Nation's Best Kept Secret (Atlanta: Bridging the Gap Communications, 1995).

9. Deborah Weiss, "A Brief History of Emergency Hormonal Contraception," Planned Parenthood Federation of America, Published by Katharine Dexter McCormick Library, March 2005, accessed 28 July 2005, <www.plannedparenthood.org/pp2/portal/files/ portal/medicalinfo/ec/fact-emergency-contraception-history.xml>; Ellertson.

10. Ibid.

11. "Statement on Contraceptive Methods," American College of Obstetricians and Gynecologists, July 1998; "Regulations and Ethical Guideline," National Institutes of Health, 45 CFR 46.202(f), <http://www.nihtraining.com/ohsrsite/guidelines/45cfr46.html>.

12. "Biomedicine: Emergency Contraception's Mode of Action Clarified," Population Briefs 11.2 (Washington, DC: Population Council, 2005), accessed 25 July 2005, <http://www.pop-council.org/pdfs/popbriefs/pbmay05.pdf>.

13. Heather Boonstra, "FDA Delays Its Decision on the Sale of Emergency Contraception," The Guttacher Report 71 (March 2004) Accessed 25 July 2005, <http://www.guttmacher.org/pubs/tgr/07/1/gr070113.html>

14. Miranda Hitti, "Sex Habits and the 'Morning After'Pill: British Study Shows Over-the-Counter Pills Bring No Change in Unprotected Sex," Web MD, 7 July 2005.

15. Marc Kaufman, "Access to Contraceptive Did Not Alter Practices, Study Says," Washington Post, 3 July 2005 A02.

16. The Facts About Plan B Emergency Contraception, (Washington, DC: National Family Planning and Reproductive Health Association, 30 June 2004), accessed 28 July 2005, <http://www.nfprha.org/pac/factsheets/planb.asp>.

17. Heather Boonstra, "FDA Rejects Expert Panel Recommendation, Blocks OTC Switch for Plan B Emergency Contraception," The Guttmacher Report 7.2 (June 2004), accessed 28 July 2005, <www.guttmacher.org/pubs/tgr/07/1/gr070113.html>.

18. Food and Drug Administration, "FDA Issues Not Approvable Letter to Barr Labs; Outlines Pathway for Future Approval," Press Release published 7 May 2004, accessed 1 August 2005, <http://www.fda.gov/bbs/topics/news/2004/NEW01064.html>.

20. Boonstra, "FDA Rejects."

21. "Introduction," Food and Drug Administration/Center for Drug Evaluation and Research, Office of Nonprescription Drugs, accessed 1 August 2005. <http://www.fda.gov/cder/Offices/OTC/default.htm>.

22. Letter to Barr Research, Inc. from Steven Galson, 6 May 04, Department of Health and Human Services, accessed 1 August 2005, <http://www.fda.gov/cder/drug/infopage/planB/planB_NALetter.pdf>.

23. "Murray, Clinton Place "Hold" on Nomination of FDA Head," Press Release published 15 June 2005, accessed 28 July 2005, <http://murray.senate.gov/news.cfm?id=238939>.

24. "Administration News: Three Senators Plan to Block Crawford's FDA Commissioner Nomination Over Agency's Lack of Action on Condom Warnings, EC," Kaiser Daily Health Policy Report, 10 June 2005, accessed 2 August 2005, <http://www.kaisernetwork.org/daily_reports/rep_index.cfm?hint=3&DR_ID=30673>.

25. Robert Pear, "Contraceptive Sales Status on Calendar at FDA," New York Times, 16 July 2005.

26. "National Politics & Policy: Senate Approves Crawford as FDA Commissioner After Months of Delay Caused by Agency's Indecision on Plan B," Kaiser Daily Health Policy Report, 19 July 2005, accessed 2 August 2005, <http://www.kaisernet-work.org/daily_reports/rep_index.cfm?hint=2&DR_ID=31459>.

27. Marc Kaufman, "FDA Official Quits Over Delay on Plan B," The Washington Post, 1 September 2005, A08.

28. Lauren Neergaard, "FDA Official Quits Over Plan B Delay," The San Francisco Gate, 31 August 2005, accessed 16 September 2005 <http://www.sfgate.com/cgi>.

29. Rita Rubin, "FDA Official Quits Over Plan B Pill Delay," USA Today, 31 August 2005, accessed 19 September 2005, <http://www.usatoday.com/news/washington/2005-08-31-fda-official-quits_x.htm>.

30. Neergaard.

31. Ibid.

32. Les Blumenthal, "Murray Hot Over Delayed Decision," The Tri-City Herald, 11 September 2005, accessed 18 September 2005, <http://www.tri-cityherald.com/tch/local/story/6956431p-6856240c.html>.

33. Ibid.

34. Neergaard.

35. Matthew Herper, "Former FDA Chief Denies Financial Conflicts," Forbes, 28 September 2005, accessed 4 October 2005, <http://www.forbes.com/facesinthenews/2005/09/28/crawford-fda-vioxx-cx_mh_0928autofacescan03.html>.

36. Marc Kaufman, "FDA Commissioner Steps Down After Two Month Rocky Tenure," The Washington Post, 24 September 2005, A07.

37. James Trussell, et al. "Emergency contraceptive pills: A simple proposal to reduce unintended pregnancies," Family Planning Perspectives 24.6 (1992): 269-73; "Emergency Contraceptive Pills," Women's Health Policy Facts, (Washington, DC: Henry J Kaiser Family Foundation, February 2004).

38. Rachel K. Jones, et al., "Contraceptive Use Among U.S. Women Having Abortions in 2000-2001," Perspectives on Sexual and Reproductive Health 34.6 (Nov/ Dec 2002): 294-394.

Jennifer Heitel Yakush

SIECUS Public Policy Associate

Washington, DC

RELATED ARTICLE: EC LEGISLATION AND OTHER ISSUES

Pharmacy Access

While the FDA continues to drag its feet on this much-delayed decision, several states have taken decisive action concerning the sale of EC.

* As of August 2005, seven states--Alaska, California, Hawaii, Maine, New Hampshire, New Mexico, and Washington--allow pharmacists to dispense emergency contraception without a physician's prescription under certain conditions. (1)

* In August 2005, Illinois mandated that all pharmacies that carry contraceptives must fill prescriptions for birth control pills, including emergency contraception (EC), just as they would any prescription, for anyone with a valid prescription.

Federal Legislation

While advocates and policymakers continue to wait for the FDA's final decision, federal legislators have introduced several bills in Congress seeking to raise awareness and increase access to EC.

* The Emergency Contraception Education Act (HR 3326) would provide $10 million for the development and dissemination of information on EC to the public and to health care providers.

* The Compassionate Assistance for Rape Emergencies Act (HR 2928, S 1264) would require emergency rooms in all federally funded hospitals to promptly provide EC to women in cases of sexual assault.

* Both of these bills are also included in the Prevention First Act (HR 1709, S 20) which includes equity in insurance coverage of prescription contraception, a mandate for medically accurate information on contraception, and a call to establish or expand teenage pregnancy prevention programs.

* Another bill (HR 2635) would require emergency contraception to be available at all military health care treatment facilities.

Reference

1. State Policies in Brief: Emergency Contraception, (Washington, DC: Guttmacher Institute, July 2005).