Change We Can Believe in – New Developments in Access to Emergency Contraception

By Susan Flinn

In March, the US District Court for the Eastern District of New York ruled in favor of science and against using political ideology to make women’s health policy. In a long-awaited decision, the court ruled that the Federal Drug Administration (FDA) politicized its decision to make Emergency Contraception (EC) available over-the-counter when it "arbitrarily" and "capriciously" refused to allow women under age 18 access to the product without a prescription. ¹ As a result of the decision, the FDA must review the age limitations and immediately allow Plan B’s manufacturer to sell EC to 17-year-olds over-the-counter.

In a sign of how much has changed since last year, the Obama Administration has announced that it will not appeal this decision. Women’s health activists celebrated the decision and were additionally heartened by the fact that it was supported by a wide array of government entities which had not, in recent years, been in the habit of supporting women’s rights, including the Food and Drug Administration (FDA), Health and Human Services, and the Department of Justice. Support for the decision is one of a few encouraging indicators that this Administration intends to focus on protecting public health rather than pandering to right-wing conservatives who oppose access to family planning and reproductive health services.

The court decision is the latest development in the long and complicated road to ensure women’s access to EC. In 2003, when Duramed’s (Plan B’s manufacturer) application to make EC available over-the-counter was being initially considered, the FDA’s independent expert panel voted 23:4 to recommend over-the-counter access with no age restrictions. (The panel also voted unanimously that Plan B is safe for non-prescription use.) Over the next few years, however, the Bush Administration engaged in numerous attempts to hamper EC availability. In 2005, Dr. Susan Wood resigned as the Director of the Office of Women’s Health and Assistant Commissioner for Women’s Health at the FDA in protest of the politicization that delayed honest consideration of the OTC access issue.

Later that year, the Government Accountability Office (GAO) released a draft report of an investigation of the denial of Duramed’s original application, describing the process as a highly unusual one that included an atypical level of involvement by high-ranking FDA officials. In 2006, the FDA approved over-the-counter access to Plan B emergency contraception, but restricted availability to women aged 18 years. Women under age 18 were still required to prescription in order to obtain Plan B.²

The FDA’s public explanation for the age restriction was that there wasn’t enough evidence that women under age 18 could use EC safely and effectively without being supervised by a health care provider. In fact, studies exploring exactly this question have found that young women aged 12-17 are just as capable as older women of understanding the EC label, and can safely use Plan B on their own.³ Opponents also claimed that making it easier for young women to avoid unwanted pregnancy might encourage them to engage in sex, have more partners, or decide not to use birth control. But research has shown that making emergency contraception easily available does not cause adolescents to have more unprotected sex or to stop using hormonal contraception or condoms.⁴ None of this should come as any surprise to the FDA because the agency’s own expert advisors reviewed the research prior to the decision, and they concluded that an age restriction was not medically justified.

The March court decision agreed with the experts, finding that the FDA's justification for limiting over-the-counter access to Plan B to women age 18 and older “runs counter to the evidence” and “is so implausible that it could not be ascribed to a difference in view or the product of agency expertise." ²  In instructing the FDA to revisit the age-restriction rationale, the judge directed the agency to documents opposing such limitations, including “memos written by the agency's own scientists, a Government Account-ability Office review of the FDA's handling of Plan B, and testimony from current and former FDA officials.” ²

What’s next? Duramed must now meet with FDA representatives to discuss proposed changes to its product’s label, and the FDA has to approve those changes. Only then can the product be marketed and provided to women under 18. The NWHN urges the FDA to move quickly to ensure that every woman who needs EC can have timely access to it – regardless of age. *

We encourage a prompt and speedy review of the evidence, as we strongly believe that over-the-counter access Plan B should be available to anyone who runs the risk of unintended pregnancy. The court has given the FDA a second chance to get their decision right, showing confidence that new leadership will allow the FDA to get back to work based on science and the public's health, without interference. We share that confidence.
Susan Wood & Kristen Moore²

References

1. Reproductive Health Technologies Project (RHTP), “Milestones on [the] Road to Over-the-Counter Plan B,” Washington, DC: RHTP, March 2009. Available online at: http://www.rhtp.org/news/media/documents/PlanBOTCTimeline.pdf.

2. Wood S, and K Moore, “Second Chance for Plan B and FDA,” Posted 05/07/2009 online at the Deming Headlight website: http://www.demingheadlight.com/ci_12311778.

3. Reproductive Health Technologies Project, “Adolescents and Over-the-Counter Emergency Contraception,” Washington, DC: RHTP, 2004; available on-line at: http://www.rhtp.org/contraception/emergency/adolescents.asp#lc.

4. Hubacher D, Grimes, D, "Noncontraceptive Health Benefits of Intrauterine Devices: A Systematic Review,” Obstetrical and Gynecological Survey 2002; 57(2): 120-128.

Susan K. Flinn is the Editor of the Women’s Health Activist.