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Physicians seek OTC access to Plan B for all ages


 

Four leading physician groups have called on federal health officials to make emergency contraception available over the counter for girls under age 17.

In a Dec. 7 letter to Health and Human Services Secretary Kathleen Sebelius, the American Medical Association, the American Congress of Obstetricians and Gynecologists, the American Academy of Pediatrics, the American Academy of Family Physicians, and seven other organizations wrote that "extensive scientific research and medical expertise" support lifting the age restriction for Plan B One-Step.

"Requiring a prescription serves as an unnecessary barrier, especially when timely access is critical for optimal effectiveness of Plan B," according to the letter. "Studies have shown teen and adult women can read and follow instructions for safe and proper use of emergency contraception. Plan B is extremely safe for teenagers to use; moreover, there is no evidence that ready access to Plan B encourages risky behaviors among teens."

Plan B One-Step, a 1.5-mg levonorgestrel tablet, is currently available without a prescription for women aged 17 years and older, and by prescription only for girls younger than 17 years. In February 2011, the Plan B manufacturer, Teva Pharmaceuticals, requested that the Food and Drug Administration expand the nonprescription access to include minors.

Last December, FDA Commissioner Margaret Hamburg announced that the drug was safe and effective, and should be approved for use by all females of childbearing age without a prescription. However, her decision was overruled by Ms. Sebelius. In a memo, Ms. Sebelius argued that there is not enough evidence to demonstrate that adolescent girls can understand the label and use the product appropriately.

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