The Joplin Globe, Joplin, MO

Business

June 21, 2013

FDA allows OTC morning-after pill, lifts age limit

WASHINGTON — The morning-after pill is finally going over-the-counter.

The Food and Drug Administration on Thursday approved unrestricted sales of Plan B One-Step, lifting all age limits on the emergency contraceptive.

The move came a week after the Obama administration ended months of back-and-forth legal battles by promising a federal judge it would take that step. Women’s health advocates had pushed for easier access to next-day birth control for more than a decade.

“Over-the-counter access to emergency contraceptive products has the potential to further decrease the rate of unintended pregnancies in the United States,” FDA drug chief Dr. Janet Woodcock said in a statement announcing the approval.

It wasn’t clear how quickly Plan B One-Step would move from behind pharmacy counters to sit on drugstore shelves. Until now, customers could buy that morning-after pill and competing generic versions without a prescription only if they proved to a pharmacist that they were 17 or older. FDA said the product will have to be repackaged to reflect the change; maker Teva Women’s Health didn’t immediately respond. FDA has not lifted age limits on competing generics.

The morning-after pill contains a higher dose of the hormone in regular birth control pills. Taking it within 72 hours of rape, condom failure or just forgetting regular contraception can cut the chances of pregnancy by up to 89 percent, but it works best within the first 24 hours. If a girl or woman already is pregnant, the pill, which prevents ovulation or fertilization of an egg, has no effect.

Back in 2011, the FDA was preparing to allow over-the-counter sales of emergency contraceptives with no limits when Health and Human Services Secretary Kathleen Sebelius overruled her own scientists in an unprecedented move.  She said she worried that girls as young as 11 could use the pill with no supervision, a concern that President Barack Obama echoed.

In April, U.S. District Judge Edward Korman blasted that decision as putting politics ahead of science and ordered the FDA to allow unrestricted sales of emergency contraceptives. He said hardly any 11-year-olds would use the pill, which costs about $50. The Obama administration lost a round in the appeals court, too, before telling the judge it would approve the one-pill brand.

Doctors’ groups and contraceptive advocates have long argued that easier access to emergency contraceptives would cut unintended pregnancies and said the drugs are safe even when used at young ages.

Social conservatives, in contrast, complain that lifting prescription requirements undermines the rights of parents and could endanger girls.

 

1
Text Only
Business
Poll

A new provision by the U.S. Department of Agriculture allows qualifying districts with high percentages of students on food assistance to allow all students to eat free breakfasts and lunches. Would you agree with this provision?

Yes
No
     View Results
Facebook
Twitter Updates
Follow us on twitter
NDN Video
13 Struck by Lightning on Calif. Beach Baseball Hall of Famers Inducted Israel, Hamas Trade Fire Despite Truce in Gaza Italy's Nibali Set to Win First Tour De France Raw: Shipwrecked Concordia Completes Last Voyage Raw: Sea Turtle Hatchlings Emerge From Nest Raw: Massive Dust Storm Covers Phoenix 12-hour Cease-fire in Gaza Fighting Begins Raw: Bolivian Dancers Attempt to Break Record Raw: Israel, Palestine Supporters Rally in US Raw: Air Algerie Flight 5017 Wreckage Virginia Governor Tours Tornado Aftermath Judge Faces Heat Over Offer to Help Migrant Kids Kangaroo Goes Missing in Oklahoma More M17 Bodies Return, Sanctions on Russia Grow Raw: Deadly Tornado Hits Virginia Campground Ohio State Marching Band Chief Fired After Probe Raw: Big Rig Stuck in Illinois Swamp