The announcement that the FDA would meet with the Plan B manufacturer Duramed, a subsidiary of Barr Pharmaceuticals, comes almost a year after Lester Crawford, then head of the FDA, indefinitely suspended a decision to allow over-the-counter sales. According to the recent FDA statement, potential approval of Plan B as an over-the-counter option would be contingent on the resolution of policy issues associated with the marketing of Plan B, specifically as it relates to age restrictions. While the drug would be available over the counter to adults 18 and over, anyone younger would only be able to access Plan B through a doctor's prescription.
Last year, policy debates focused on the concern that if Plan B were made more widely available, it would increase risk taking and promiscuity, with women engaging in unprotected sex and even abandoning more effective forms of contraception, increasing the risk of unintended pregnancies or sexually transmitted diseases. News of the FDA announcement makes timely a 2005 UCSF study published in the Journal of the American Medical Association. Lead author Tina Raine, MD, MPH, associate professor of obstetrics, gynecology, and reproductive sciences and medical director of the New Generation Health Center - a family planning clinic for adolescents and young adults - and her co-authors found that use of emergency contraception increased because of availability, but the number of individuals who engaged in risky and unprotected sex did not increase. "We found that if you give women access to emergency contraception, they are no more likely to have unprotected sex," said Raine. "Basically, if women have it, they do not respond irresponsibly or inappropriately." More than 3 million unintended pregnancies occur each year in the United States, which advocates say could be averted if emergency contraception were easily accessible and used. According to the study, efficacy trials have demonstrated that the risk of pregnancy after a single act of unprotected intercourse is reduced by 75 percent with use of emergency contraception. The study also showed that, even with access to emergency contraception, women did not abandon use of alternative forms of contraception. "Given this, it is unlikely that just because there is accessibility to the pill, it would lead to higher pregnancy rates," Raine said. The decision to provide the contraceptive over the counter to adults 18 and over is one of the primary issues the FDA is working to resolve with Duramed. According to Raine, ideally, Plan B could be available to all ages. "What we really want to see is accessibility across the board," said Raine. "Over half of pregnancies are unintended. Our study looked at over 2,100 women ages 15 to 24. We found that clearly accessibility to the pill did not compromise contraceptive or sexual behavior. So it seems unreasonable to restrict access to emergency contraception to clinics." Links: "Direct Access to Emergency Contraception Through Pharmacies and Effect on Unintended Pregnancy and STIs"
JAMA. 2005;293:54-62 "Sexual behavior not influenced by increasing young women's access to 'morning after pill,' UCSF study finds"
January 4, 2005 Plan B Q&A with UCSF School of Pharmacy Faculty
Lorie Rice, MPH, associate dean for external affairs, in the UCSF School of Pharmacy and assistant clinical professor of clinical pharmacy, and Shareen El-ibiary, also assistant professor in the department, answer our questions about Plan B emergency contraception and the FDA.