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Plan B Pill for 17-Year-Olds
The FDA has signaled that it will approve Plan B, the so-called "morning after" pill, without a prescription for women age 17 and older.
Plan B is already available to women age 18 and older without a prescription. It was first approved in 1999 and became available without a prescription in 2005 for women age 18 and older.
In March, U.S. District Court Judge Edward Korman of New York ordered the FDA to extend Plan B's availability without a prescription to 17-year-old women -- and to do so within 30 days.
In his ruling, Korman noted that Plan B "is the only emergency contraceptive drug currently available in the United States." He also wrote that politics was a factor in the FDA's 2005 decision to limit nonprescription use of Plan B to women age 18 and older.
The FDA today announced that it will not appeal that ruling, and that the FDA has sent a letter to Plan B's maker stating that, upon submission and approval of an appropriate application, the company may market Plan B without a prescription to women 17 years of age and older.
Plan B is made by Duramed Research, a subsidiary of Teva Pharmaceuticals. In an email to WebMD, Teva spokeswoman Denise Bradley states, "We support the FDA's decision to expand OTC [over-the-counter] access for Plan B to consumers 17 and older. The company believes that timely access to Plan B is extremely important, as the sooner Plan B is taken the more effective it is. We will continue to work closely with FDA to ensure that all provisions of this decision are met."
Plan B is already available to women age 18 and older without a prescription. It was first approved in 1999 and became available without a prescription in 2005 for women age 18 and older.
In March, U.S. District Court Judge Edward Korman of New York ordered the FDA to extend Plan B's availability without a prescription to 17-year-old women -- and to do so within 30 days.
In his ruling, Korman noted that Plan B "is the only emergency contraceptive drug currently available in the United States." He also wrote that politics was a factor in the FDA's 2005 decision to limit nonprescription use of Plan B to women age 18 and older.
The FDA today announced that it will not appeal that ruling, and that the FDA has sent a letter to Plan B's maker stating that, upon submission and approval of an appropriate application, the company may market Plan B without a prescription to women 17 years of age and older.
Plan B is made by Duramed Research, a subsidiary of Teva Pharmaceuticals. In an email to WebMD, Teva spokeswoman Denise Bradley states, "We support the FDA's decision to expand OTC [over-the-counter] access for Plan B to consumers 17 and older. The company believes that timely access to Plan B is extremely important, as the sooner Plan B is taken the more effective it is. We will continue to work closely with FDA to ensure that all provisions of this decision are met."
Labels: morning after pill, Plan B
