FDA To Allow Sale Of Plan B Emergency Contraception To 17-Year-Olds

Main Category: Women's Health / Gynecology
Also Included In: Sexual Health / STDs;  Pediatrics / Children's Health;  Regulatory Affairs / Drug Approvals
Article Date: 24 Apr 2009 - 1:00 PDT

email to a friend   printer friendly   opinions  

FDA on Wednesday announced that it will allow the non-prescription sale of the emergency contraceptive Plan B to individuals ages 17 years and older, in compliance with a federal judge's March 23 ruling that the agency's 2006 decision to limit access to women ages 18 and older was politically motivated and scientifically flawed, the Washington Post reports. U.S. District Judge Edward Korman had ordered FDA to make Plan B available to 17-year-olds within 30 days and to re-examine other restrictions, including if non-prescription access should be available to all ages (Stein, Washington Post, 4/23). Plan B consists of a two-pill regimen that, when taken within 72 hours of sexual intercourse, is highly effective at preventing pregnancy. The new changes will allow women and men ages 17 and older to obtain the drug at pharmacies, hospitals and clinics after showing proof of age, the New York Times reports.

FDA said in a statement that it will comply with Korman's ruling. The agency said a letter has been sent to Teva Pharmaceuticals, the company that manufactures Plan B, saying that it "may, upon submission and approval of an appropriate application, market Plan B without a prescription to women 17 years of age and older" (Harris, New York Times, 4/23). It is unclear if FDA will review whether Plan B should be available to individuals younger than age 17, the Post reports.

Women's health and family planning advocates praised the decision. Nancy Northup, president of the Center for Reproductive Rights, which filed a lawsuit challenging FDA's initial decision, said the new announcement is a "good indication that the agency will move expeditiously to ensure its policy on Plan B is based solely on science." She added, "It's time the FDA restores confidence in its ability to safeguard the public health and put medical science first" (Washington Post, 4/23). Cecile Richards, president of the Planned Parenthood Federation of America, said the decision "is a strong statement to American women that their health comes before politics" (New York Times, 4/23). Susan Wood, a former top women's health official at FDA who resigned in 2005 in protest of FDA's handling of the Plan B decision, said, "This issue served as a clear example of the agency being taken off track, and it highlighted the problems FDA was facing in many other areas" (Alonso-Zaldivar, AP/Yahoo! News, 4/23).

The decision was criticized by antiabortion-rights groups who oppose Plan B and have long claimed that the drug is unsafe for minors, the Post reports. Wendy Wright of Concerned Women for America said FDA's announcement was "driven by politics, not what is good for patients or minors" (Washington Post, 4/23). She added that FDA should have challenged Korman's ruling because a "judge's opinion can't change the fact that giving women a false impression about a drug's effectiveness forces the FDA to become snake-oil salesmen" (Washington Times, 4/23). The Los Angeles Times reports that conservative groups also argue that Plan B will encourage promiscuity among young girls and could be abused by teenagers (Levey, Los Angeles Times, 4/23).

Broadcast Coverage

ABC's "World News" on Wednesday reported on the announcement, including comments from Wood (Stark, "World News," ABC, 4/22).

Reprinted with kind permission from http://www.nationalpartnership.org. You can view the entire Daily Women's Health Policy Report, search the archives, or sign up for email delivery here. The Daily Women's Health Policy Report is a free service of the National Partnership for Women & Families, published by The Advisory Board Company.

© 2009 The Advisory Board Company. All rights reserved.

• Additional
• References
• Citations