Access to emergency contraception (EC) has a storied history in the USA and directly impacts victims of sexual violence. Ci3 and the Section of Family Planning & Contraception Research, along with the Center for the Study of Gender and Sexuality hosted a challenging and informative presentation that explored this intersection. Dr. Susan F. Wood, Associate Professor of Health Policy and Director of the Jacobs Institute of Women’s Health at The George Washington University spoke about her role and observations surrounding over-the-counter EC access.
As Assistant Commissioner for Women’s Health at the FDA, Dr. Wood directed the FDA Office of Women’s Health from 2000 to 2005, at which point she resigned on principle over the continued delay of approval of EC over-the-counter.
Dr. Susan F. Wood
Dr. Wood’s talk, Controversy over Contraception: From Emergency Contraception to Contraceptive Coverage to the Affordable Care Act, began with the historical context of women’s health and federal funding and ended with the implications of the ACA specifically regarding contraceptive coverage and access.Her talk focused primarily on the ongoing struggle to make EC available to all women over the counter.
In her role at the FDA, Dr. Wood witnessed the agency’s attempts to regulate the practice of medicine and pharmacy when it came to emergency contraception, an unprecedented course of action not only in its role as a government agency but also because of the impact on women’s access to family planning services.
The FDA approved Plan B as EC in 1999 as a prescription product for all women of childbearing potential. The manufacturer sought over-the-counter (OTC) approval in 2003.
At this early stage, it was already known that:
- EC is safe and suitable for all women.
- EC does not cause an abortion (“The only relation between EC and abortion is that EC prevents the need for an abortion,” says Dr. Wood.)
- EC needs to be taken soon after (within hours of) intercourse to be the most effective.
- EC provides victims of rape the option to prevent an unwanted pregnancy.
Despite these facts and extensive studies on the safety for women of all ages, politics and myths about EC — that it would increase adolescent sexual activity, encourage pedophilia, or cause an abortion — delayed FDA approval.
Not until August 2006 did the FDA approve Plan B over-the-counter (OTC) at pharmacies and health clinics, and this approval was limited to women 18 years and older; younger women would still require a prescription. Between 2003-2006, recommendation for approval had been overruled several times, Dr. Wood resigned, and activists across the country lobbied the FDA to make decisions that reflect good medicine and public interest.
In March 2009, a US district court ruled that the FDA decision to restrict access to women under 18 was “arbitrary and capricious” and ordered the FDA to lift restrictions on 17-year-olds within 30 days. Also in 2009, the FDA approved One Step (a one-dose version of Plan B) and Next Choice (a two-dose generic version), but the age restriction remained at 17. In 2010, with the age restriction still in place, The Center for Reproductive Rights filed for contempt of court citing the delays.
In 2011, Teva (One Step) released new data and filed an application to lift the age restriction. With the age restriction ready to be lifted, the FDA was overruled by Health and Human Services Secretary Kathleen Sebelius, who cited the lack of evidence on 11- to 12-year-olds’ ability to use the product. Although this argument was unprecedented and unfounded, President Obama agreed with Kathleen’s lack of evidence argument and the age restriction remained.
It took until June 2013 for the FDA to approve Plan B One Step OTC for all women without age restriction. That is, it took 10 years for women to have OTC access to a safe medicine approved by the FDA for women of all ages.
Plan B as seen over-the-counter. Image from Dr. Wood’s presentation 11/19/13.
How does this history of EC approval, restrictions, stigma, and accessibility relate to gender-based violence and the 16 Days of Activism Against Gender-Based Violence campaign?
- EC is an essential contraceptive option for women who experience sexual violence. According to the FDA: “Seven out of every eight women who would have gotten pregnant will not become pregnant after taking Plan B, Plan B One-Step, or Next Choice.” Dr. Wood adds, “There isn’t any difference in efficacy for the use of EC for victims of sexual violence.”
- EC potentially prevents the extra burden of an unwanted pregnancy for rape victims.
- The cost of EC may be prohibitive; EC costs about $50 OTC in most pharmacies. Under the Affordable Care Act, the cost should still be covered through prescription. According to Dr. Wood, in the cases of rape, specifically for populations who cannot afford the $50, access to EC through family planning clinics may reduce the cost.
- If a victim of sexual violence seeks care at an emergency room, EC should be provided as part of her treatment.
- Even though EC is available OTC, doctors should continue prescribing and counseling EC, especially for victims of sexual violence. According to Dr. Wood, “Time is of the essence, so provision of information, and advance provision of EC can be helpful for all women. In addition, awareness by providers of other EC methods, such as insertion of copper IUD or use of Ella (a prescription only emergency contraception that is effective for up to 5 days) is important.”