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FDA To Decide Whether To Remove Restrictions on Plan B One-Step

FDA To Decide Whether To Remove Restrictions on Plan B One-Step

December 6, 2011 — FDA faces a deadline of Wednesday to respond to a request from Teva Pharmaceutical Industries to allow sales of its Plan B One-Step emergency contraceptive without a prescription to people of any age, the Washington Post reports. If FDA approves the request, the pill would be available on store shelves, eliminating the current requirement that women prove they are at least 17 years old or obtain a prescription to purchase the drug.

Plan B One-Step can prevent pregnancy and is most effective if taken within 72 hours after sex (Stein, Washington Post, 12/5). Women's health groups since 2001 have sought wider access to the emergency contraception, first approved in 1999 for purchase only by prescription. Teva in 2003 sought approval to make Plan B available without a prescription. The Bush administration delayed a decision for three years amid protests from various lawmakers, women's groups and some officials within FDA that politics were playing a larger role in its decision than science (Women's Health Policy Report, 2/14).

FDA in 2006 approved the drug for "behind-the-counter" sales to women ages 18 and older. The agency later lowered the age to 17 after a federal judge ruled that its 2006 decision to limit access to women ages 18 and older was politically motivated and scientifically flawed (Women's Health Policy Report, 4/23/09).

Earlier this year, Teva submitted additional data to FDA detailing the actual use of the drug among young women ages 11 to 16 (Women's Health Policy Report, 2/14). Teva's Amy Niemann said, "We have a tremendous amount of safety information regarding this particular product. It is classified as very, very safe." She added, "Hopefully we'll get full approval. It would be an historic and important decision for women."

Debate Over Access

Supporters of Teva's request say lifting the age restrictions is important to ensuring that women can access Plan B when they need it. Susan Wood -- a top FDA official who resigned in protest of the agency's delays on Plan B and is now at George Washington University -- said, "If you [go] into a Wal-Mart and the pharmacy is closed, you're out of luck." She added, "By having it on the shelf, more women will become aware of the availability of emergency contraception and won't have to ask someone in an emergency situation about a very private and personal situation."

Nancy Northup of the Center for Reproductive Rights said, "We think it's important for both the original two-pill as well as the new one-pill One-Step to be available to all women of all ages. It's especially important for younger women, for whom cost can be an important issue."

Conservative lawmakers and groups argue that girls might not use the drug properly without a doctor's supervision. They also say that wider availability of EC could encourage sexual activity or enable men who rape underage girls to force them to take the drug. "When anybody can buy an emergency contraceptive like this over the counter, you open the door for all sorts of abuse, and especially so when it comes to child abuse and child exploitation," Janice Crouse of Concerned Women for America said (Washington Post, 12/5).