Judge drops restrictions on EC age — finally!
By Anita Brakman, MS Director of Education, Research & Training Physicians for Reproductive Choice and Health New York City
Melanie Gold, DO, FAAP Clinical Professor of Pediatrics University of Pittsburgh School of Medicine Staff Physician University of Pittsburgh Student Health Service
In a decision more than 10 years in the making, a U.S. Federal District judge ruled April 5, 2013, that the Food and Drug Administration (FDA) must lift age and point-of-sale restrictions on Plan B One-Step emergency contraception (EC) within 30 days.
Plan B, a levonorgestrel EC product, was first approved as a prescription-only medication in 1999. Since that time, medical, legal, and advocacy groups have struggled to bring this safe medication over-the-counter to enhance timely access, while being blocked by delays and political interference along the way.
Before the court’s most recent ruling, this method was available over the counter (OTC) in pharmacies, but only to women age 17 or older and only when government-issued identification could be provided. Younger women and those without identification were required to have a prescription to access Plan B.
This dual-label structure also forced the drug to be “behind-the-counter” in order for pharmacists to check age and identification requirements, cutting off access to the drug during hours when pharmacy desks were closed or unstaffed. In practice, even individuals 17 years of age or older faced barriers in trying to access the medication. Such barriers are especially problematic considering this method of EC is much more effective the sooner it is taken after unprotected sex.
The most recent hurdle in the path to EC access came in December 2011 when Kathleen Sebelius, secretary of the Department of Health and Human Services, overrode an FDA decision that would have removed age restrictions and allowed sale of the medication on open shelves in any store where OTC medications are sold. This intervention sparked the renewal of an earlier lawsuit on the matter and resulting eventually in the April 5 decision.
The judge heavily criticized the secretary, saying her “directive ... forced the agency to ride roughshod over the policies and practices that it has consistently applied in considering applications for switches in drug status to over-the-counter availability” and calling her actions “arbitrary, capricious, and unreasonable.”1
What will happen?
Removing point of sale and age restrictions will broaden access to EC in a variety of ways. Women under 17 soon should be able to purchase the medication without delays caused by visiting providers to obtain prescriptions. For older teens and adults, Plan B should soon be available on open shelves in pharmacies, as well as in grocery stores, convenience stores, and anywhere that OTC medications are stocked. Availability of EC at places such as gas stations could provide access at critical moments when unprotected sex has occurred and pharmacies are closed for the night.
Opponents have expressed concern that increased access to EC will put young adolescents in danger and increase risk-taking behavior. Fortunately, research clearly disputes both of these claims. Recent data published by the journal, Pediatrics, discusses the very small percentage of sexually active 10-, 11-, and 12-year-old girls (.6%, 1.1%, and 2.4% respectively); incidence of pregnancy among this group is miniscule.2 Therefore, the likelihood of this group to need emergency contraception is extremely low.
There is no evidence of levonorgestrel EC being harmful to patients, regardless of age. Furthermore, several studies have established that increased access to EC does not increase episodes of unprotected sex or decrease use of ongoing contraception. Increased access to EC simply increases the likelihood of patients to use the method when they need it and to take it in a timely way.3-6
What is your role?
Despite OTC access for levonorgestrel EC methods, clinicians will still have an important role in counseling and dispensing emergency contraceptives. The ulipristal acetate EC pill, ella, is still prescription-only regardless of age. Ella has an advantage in that it does not lose efficacy over a five-day period,7 and therefore might be preferable for young women who seek EC four or more days after unprotected sex. It is also more effective in women with higher body mass index, compared to Plan B or generic equivalents.8 The most effective form of EC remains the copper intrauterine device, which has the added benefit of ongoing long-term contraception but requires a clinician for insertion.9
Finally, educating patients about emergency contraception is still essential if they are to know how, when, and in what circumstances to seek it out, whether OTC or by prescription. Also, some patients still might seek prescriptions for Plan B in order to use insurance coverage. The cost of LNG EC ranges from about $35 to $60,10 which remains a significant barrier, especially to teens.
As this column goes to press, we are still awaiting action on this ruling by the FDA and remain hopeful that increased access will be in place for teens and adults in the coming days. [Editor’s note: On April 5, 2103, Contraceptive Technology Update issued an e-bulletin on the judge’s ruling. To receive breaking news as it occurs, provide your email address to AHC Media customer service at [email protected] or (800) 688-2421.]
References
1. Tumino v. Hamburg, United States District Court Eastern District of New York. April 5, 2013.
2. Finer LB, Philbin JM. Sexual initiation, contraceptive use, and pregnancy among young adolescents. Pediatrics 2013. Doi:10.1542/peds.2012-3495.
3. Raine T, Harper C, Leon K, et al. Emergency contraception: advance provision in a young, high risk clinic population. Obstet Gynecol 2000; 96:1-7.
4. Belzer M, Yoshida E, Tejirian T, et al. Advanced supply of emergency contraception for adolescent mothers increased utilization without reducing condom or primary contraception use. Research Presentations. J Adolesc Health 2003; 32:122-123.
5. Gold, MA, Wolford JE, Smith KA, et al. The effects of advance provision of emergency contraception on adolescent women’s sexual and contraceptive behaviors. J Pediatr Adolesc Gynecol 2004;17(2):87-96.
6. Raine TR, Harper CC, Rocca CH, et al. Direct access to emergency contraception through pharmacies and effect on unintended pregnancy and STIs. JAMA 2005; 293(1): 54-62.
7. Glasier AF, Cameron ST, Fine PM, et al. Ulipristal acetate versus levonorgestrel for emergency contraception: a randomised non-inferiority trial and meta-analysis. Lancet 2010; 375:555-562.
8. Glasier A, Cameron ST, Blithe D, et al. Can we identify women at risk of pregnancy despite using emergency contraception? Data from randomized trials of ulipristal acetate and levonorgestrel. Contraception 2011; 84:363-367.
9. Stewart F, Trussell J, Van Look PF. Emergency contraception. In: Hatcher RA, Trussell J, Nelson A, et al. Contraceptive Technology, 19th revised edition. New York: Ardent Media, 2007.
10. Reproductive Health Technologies Project. FDA approved emergency contraceptive pills currently on the US market. Fact sheet. Accessed at http://bit.ly/12fWdjn.
In a decision more than 10 years in the making, a U.S. Federal District judge ruled April 5, 2013, that the Food and Drug Administration (FDA) must lift age and point-of-sale restrictions on Plan B One-Step emergency contraception (EC) within 30 days.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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