Morning-After Pill Must Be OTC for All Ages, Judge Rules


April 05, 2013

In a decision praised by several leading medical societies, a federal judge today ordered the US Food and Drug Administration (FDA) to make an emergency oral contraceptive known as the morning-after pill available to all adolescent girls without a prescription within 30 days.

Previously, the emergency contraceptive formulation of levonorgestrel marketed as Plan B One-Step (Teva Pharmaceuticals), a 1-pill version of Plan B, could be bought over the counter (OTC) by women aged 17 years and older and men aged 18 years and older. Adolescent girls younger than 17 years could obtain the drug and other forms of emergency contraception only by prescription.

An FDA advisory committee in 2011 recommended lifting the prescription requirement, concluding that the morning-after pill could be used safety by all girls of reproductive age, but Health and Human Services Secretary Kathleen Sebelius nixed that idea, saying that 11-year-old girls having periods lacked the maturity to use the drug.

In a suit filed by reproductive rights groups challenging the FDA position, Senior US District Judge Edward Korman in New York City ruled that the government's position on the morning-after pill is "arbitrary, capricious, and unreasonable."

The American Academy of Pediatrics, the American College of Obstetricians and Gynecologists, and the Society of Adolescent Health and Medicine immediately applauded the ruling.

"This decision reflects the overwhelming evidence that emergency contraception is safe and effective for all women of reproductive age," the societies said in a press release.