you don't know what you don't know, you know?Do you know what "the morning after pill" does? Did you know the morning after pill is available over the counter, without a prescription? Do you know how its different from "the abortion pill"? Most are aware that reproductive rights are highly politicized, but did you know that the approval of the morning after pill for over the counter distribution was stalled by the FDA for years, not for any valid medical concern, but solely as a result of the views of the current regime and its politics? I find it *maddening* how ill informed, ill equipped, and ultimately powerless our government leaves us in the face of decisions surrounding our bodies and our families. And it's not people like you or me who suffer as a result - you, the priveleged, the educated, the aware, reading blogs and drinking Starbucks. It's the poor who truly suffer with the unintended pregnancies that perpetuate cyclical poverty. Margaret Sanger knew in the early 20th century that the key to solving one symptom of poverty was education and access to birth control - to teach and support people in making the choice to not create another mouth to feed. Today's political climate and ridiculous rhetoric of abstinence squelches progress and leaves me with little hope that we have learned or evolved at all in the past one hundred years. Woman and her body are as captive as ever. Below is a paper* I wrote last semester that reveals some of the gory details of our government's ideological grip over our freedom to choose. *Please forgive the formatting. I'm too lazy to fix it. In 2006, after three years of delays, controversy, and heated debate, the FDA approved the emergency contraception pharmaceutical with the brand name "Plan B" for distribution without a prescription to men and women aged 18 and over. Though now available without a written prescription from a doctor, the controversy surrounding Plan B continues as some pharmacists have refused to stock and/or sell the drug based on their personal beliefs, and advocates of the drug are concerned that consumers may not have the information needed to effectively access and use the drug. Several campaigns have launched to educate the public, improve access for those under 18 and victims of sexual assault, and promote cooperation of pharmacies and health care professionals. In this paper, I will assess the "Back Up Your Birth Control" campaign for emergency contraception by reviewing the history of the FDA approval to provide context for the campaign. Then I will analyze several elements of the campaign including audiences, key messages, and strategies. Plan B is a form of emergency contraception also known as "the morning after pill." The drug is composed of high levels of the hormone levonorgestrel, an active ingredient in many birth control pills. Plan B may prevent pregnancy in one of three ways: by stopping the release of an egg from the ovary; by preventing the fertilization of an egg; or preventing an egg from attaching to the uterus. When taken as directed within 72 hours of intercourse, Plan B may reduce the possibility of pregnancy by up to 89% (Duramed Pharmaceuticals, Inc., 2007). Unlike Mifeprex (also known as RU-486 or "the abortion pill"), Plan B prevents conception and does not affect an existing pregnancy (defined as a fertilized egg already attached to the uterus) (Duramed Pharmaceuticals, Inc., 2007). Plan B was approved for over the counter distribution to adults over 18 in August of 2006, though the journey to approval was a sordid affair. Plan B was initially approved by the FDA for distribution with a prescription on July 28, 1999 (FDA, 1999). In April 2003, the drug manufacturer filed an application with the FDA to make the drug available over the counter (OTC) without a prescription. In May 2004, the FDA rejected the application, citing concerns about the safety of the drug for adolescents 16 and under due to under-representation of this population in the research sample (Galston, 2004). After the rejection from the FDA, the manufacturer resubmitted the request for OTC status in July 2004, requesting that sales be limited to older teens and women. Nearly a year later in April 2005, Senators Hillary Clinton and Patty Murray announced they would block the nomination of the new FDA commissioner if the FDA did not make a decision about the OTC status for Plan B. The secretary of Health and Human Services promised a decision by September 1, and the senators lifted their ban. The FDA delayed a decision, citing the need to create rules for enforcing the age restriction on the drug. In September 2005, with no decision handed down, the new FDA commissioner Lester Crawford resigned after five months in office (Associated Press, 2006). In the midst of this political jockeying, the Government Accountability Office (GAO) published a report which characterized the process the FDA followed to deny the application as "unusual" (GAO, 2005). In the report, published in November 2005, the GAO revealed that Plan B was the only "OTC switch" application between 1994 and 2004 that was not approved after the advisory committees recommended approval. The agency provided four key findings in their report. First, the "not-approvable letter" was not signed by directors that would normally have signed because they disagreed with the decision to block OTC availability. Second, high level management in the FDA was more involved in this case than in other OTC switch cases. Third, the GAO found conflicting accounts of whether the decision to decline the application was made before the review process was complete. Finally, the acting Director of the FDA stated "novel" concerns about the "potential behavioral implications for younger adolescents," and did not follow traditional FDA practice (GAO, 2005). In March 2006, Senators Clinton and Murray again blocked the nomination of a new FDA commissioner. The FDA requested the manufacturer change its application to seek nonprescription sales for women 18 and older only, and the application was approved in August 2006 (The Associated Press, 2006). Since the approval of Plan B for OTC distribution, the controversy and confusion has continued. Advocacy groups have launched several campaigns to help cut through the politics and noise to educate the public and raise awareness about emergency contraception availability. One such campaign is the "Back Up Your Birth Control (BUYBC)" campaign for emergency contraception (EC). The campaign website provides the following overview of the campaign: "The Back Up Your Birth Control Campaign unites more than 100 national and local medical organizations and women's health advocacy groups to increase awareness of and improve access to emergency contraception. This campaign is coordinated by the National Institute for Reproductive Health, the national research, education and training arm of NARAL Pro-Choice New York" (Back Up Your Birth Control, 2007). The ultimate goal of the campaign is to reduce unintended pregnancy and "raise awareness of EC and encourage advance provision so every woman has EC on hand before the condom breaks, she forgets to refill her birth control prescription, or she has sex when she didn't want or plan to" (Back Up Your Birth Control, 2007). The campaign contends that "EC still remains the 'best kept secret' in women's health care" and "improved public education is needed to ensure that all women can back up their birth control with EC. The BUYBC campaign is dedicated to providing the information and resources necessary to allow all women, especially young women, to access EC in a timely manner" (BUYBC, 2007). The campaign is rooted in five key messages. First, "Women need to hear about it. Health care providers need to talk about it. Pharmacists need to stock it." Here, the campaign website asserts that 60% of voters don't know about emergency contraception, and only 6% of women have ever used it. "Know where to get EC." Women should have a plan to get EC from a clinic, a pharmacy, or a doctor. This is especially important for women under 18 who cannot purchase EC over the counter. "You can be prepared. Don't wait for a crisis." In this message, the campaign urges women to have EC on hand in case of an emergency. "The sooner, the better." The longer a woman waits to get and use EC, the less effective it is. The final key message is: "Common sense and common ground." EC is available to prevent unintended pregnancy, and because of the confusion and controversy, its potential impact is largely unfulfilled (BUYBC, 2007). Experts play a key role in the credibility and success of this campaign. The list of over 100 campaign sponsors includes medical and legal groups, and several women's advocacy groups, including the American Civil Liberties Union Reproductive Freedom Project, Family Health International, Pharmacy Access Partnership, Physicians for Reproductive Choice and Health, and Planned Parenthood Federation of America (BUYBC, 2007). Aligning the campaign a multitude of expert organizations lends credibility to the campaign and the information on the website, and also provides the campaign with several organizations through which to distribute information about the campaign. The key audience for the campaign is women of reproductive age. Strategies to reach women include grassroots organizing, provider and public education, and the BUYBC day of activism. The website provides a comprehensive overview of the campaign, and has links to all of the campaign partner organization's websites as well as several other websites targeted to populations outside the scope of the BUYBC campaign, particularly teens. The campaign promotes grassroots activities by supplying all campaign materials on their website. The campaign leverages its many cosponsors as arms of the campaign to reach women across the country. Though somewhat disorganized, this method is effective in reaching women with diverse interests and memberships through focused effort on their annual Day of Action. The 6th annual Day of Action occurred on March 20, 2007. The symbol of the campaign is Rosie the Riveter – "a symbol of the new freedom women found when they left traditional roles to join the war effort" (BUYBC, 2007). The BUYBC campaign leverages Rosie as a symbol of strength, independence, and a "woman who makes her own destiny" (BUYBC, 2007). The media relations plan for the campaign is ad hoc. Organizers craft press releases to coincide with the National Day of Action each year, and intermittently release statements to announce campaign activities. The website also encourages women to take action and write Op-Ed pieces for local publications. The campaign launched February 1, 2002 and is ongoing with no announced end date. The Back Up Your Birth Control campaign attempts to help women make sense of emergency contraception through the controversy, politics, and mixed messages. The campaign was launched with the noble mission to educate women to prevent unintended pregnancy by having emergency contraception on hand. The reach and credibility of the campaign is enhanced by partnerships with over 100 agencies representing women's advocacy, legal, pharmaceutical, and medical organizations. The comprehensive website includes a wealth of information about emergency contraception and access, as well as links to the partner organizations and to sites targeting populations outside the scope of this campaign, specifically teens. The campaign also wisely uses its website as a means to distribute campaign materials, encouraging those who visit to become advocates. A criticism of the campaign is that it includes too many messages, but the issue of emergency contraception is so complex and the messages have changed so much over time it would be difficult to break the story of Plan B down to just a sound byte. While I believe the campaign does an excellent job of making information available to women, I have never seen campaign materials other than when searching for them explicitly on the internet. The campaign would be more effective if it took a more active approach, sending materials out to display in doctors offices, lobbies and waiting rooms, hospitals, and even social services offices and universities. Direct mail might be another effective way to get messages about emergency contraception to the women who need to hear them. While the drug is available over the counter, I think doctors and women's health care professionals would be the most effective channels through which to distribute information about emergency contraception and how to access it. In the midst of conflicting and complicated messages and a sordid political history, the Back Up Your Birth Control campaign website cuts through the noise to provide women with clear messages about emergency contraception. If you've read this far, please don't plagerize me. That would be totally uncool. References Back Up Your Birth Control. (2007). 2007: The New Dual-Label Environment. Retrieved November 9, 2007 from http://www.backupyourbirthcontrol.org/documents/toolkit/2007-_The_New_Dual-Label_Enviro_1.29.07.pdf. Back Up Your Birth Control. (2007). What is EC? Retrieved November 9, 2007 from http://www.backupyourbirthcontrol.org/ec/index.htm. Back Up Your Birth Control. (2007). Talking Points on Emergency Contraception. Retrieved November 9, 2007 from http://www.backupyourbirthcontrol.org/documents/toolkit/Talking_Points_on_EC_1.12.07.pdf. Back Up Your Birth Control. (2007). Campaign Co-Sponsors. Retrieved November 9, 2007 from http://www.backupyourbirthcontrol.org/materials/cosponsors.htm. Duramed Pharmaceuticals, Inc. (2007). Taking Plan B. Retrieved November 9, 2007 from http://www.go2planb.com/ForConsumers/TakingPlanB/Default.aspx. Duramed Pharmaceuticals, Inc. (2007). How Plan B Works. Retrieved November 9, 2007 from http://www.go2planb.com/ForConsumers/AboutPlanB/HowItWorks.aspx. FDA. (1999). Center for Drug Evaluation and Research, Application Number NDA 21045. Retrieved November 9, 2007 from http://www.fda.gov/cder/foi/nda/99/21-045_Plan%20B_Approv.pdf. Galston, Steven. (2004). Letter. Retrieved November 9, 2007 from http://www.fda.gov/cder/drug/infopage/planB/planB_NALetter.pdf. Government Accountability Office. (2005). FOOD AND DRUG ADMINISTRATION: Decision Process to Deny Initial Application for Over-the-Counter Marketing of the Emergency Contraceptive Drug Plan B Was Unusual. Retrieved November 9, 2007 from http://www.gao.gov/new.items/d06109.pdf. The Associated Press. (2006). Timeline: History of the morning after pill. Retrieved November 9, 2007 from http://www.msnbc.msn.com/id/14231721/. |