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Judge orders 'Morning-After' Pill be sold over-the-counter

7:47 AM, Apr 6, 2013   |    comments
Plan B One-Step (levonorgestrel) tablet, one of the brands known as the "morning-after pill." A federal judge ruled that age restrictions on over-the-counter sales of the morning-after pill are "arbitrary, capricious and unreasonable," April 5, 2013. (Teva Women's Health/AP Photo)
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(ABC NEWS) -- The "morning-after" pill, also known as Plan B, could land on drugstore shelves right next to the condoms and cough drops as early as May.

A federal judge today ordered the Food and Drug Administration to allow emergency contraception, such as Plan B, to be sold over-the-counter. In his ruling, Judge Edward Korman repeatedly referred to the "bad faith" that resulted in restricted access to the drug in the past.

Currently, women under 17 need a prescription to purchase emergency contraception. Although women 17 and older don't need a prescription, the morning after pill is available only behind the pharmacy counter and an ID is required.

The FDA can appeal the ruling.

"Today science has finally prevailed over politics," said Nancy Northup, president and CEO of the Center for Reproductive Rights, which first petitioned the FDA to make the emergency contraceptive available over the counter in 2001. "Women all over the country will no longer face arbitrary delays and barriers just to get emergency contraception."

The ruling comes after Health and Human Services Secretary Kathleen Sebelius overruled the FDA when it recommended that emergency contraception be sold over the counter in December 2011. The FDA spent 10 months reviewing scientific data before making its decision, but Sebelius said there wasn't enough data to declare the product safe.

"Indeed, it is hardly clear that the secretary had the power to issue the order, and if she did have that authority, her decision was arbitrary, capricious and unreasonable," Korman, who presides over the District Court of Eastern New York, wrote in his ruling.

The morning after pill is intended to be used when other contraception fails, such as when a condom breaks. Containing the synthetic hormone levonorgestrel, the pill works by preventing a fertilized egg from attaching itself to the uterine wall. But it must be taken within 72 hours of unprotected sex. It cannot terminate an existing pregnancy.

Speaking at a news conference, Dr. Cora Collette Breuner, a pediatrician at Seattle Children's Hospital, said the ruling made her proud "as a woman and as a doctor and as a mother of three children.

"This statement and this ruling are long overdue and especially welcome by all of us at the American Academy of Pediatrics," Breuner said.

However, she said more needed to be done to be sure the pill was affordable to all women, regardless of their finances. It should be priced so that sexually active women 14, 15 and 16 years old can afford it, Breuner said.

Plan B's manufacturer first filed an application to make the emergency contraceptive available without a prescription in 2003, after a group of 70 medical and public health organizations petitioned for this in 2001. The FDA allowed Plan B to become available without a prescription to women 18 and over in 2006. In 2009, a judge forced the FDA to lower that age to 17.

Dr. Jennifer Ashton, a senior medical contributor for ABC News, said women should remember that an emergency contraceptive is not 100 percent effective, and that it carries a risk for irregular bleeding.

"Ideally, plan B should be used in consultation with a health care provider so these other issues can be addressed," she said. "Plan B is also not intended to serve as a primary means of contraception."

Plan B has been sold over-the-counter in China since 1998, and a study published in 2011 in the journal Human Reproduction involving 2,521 women found no adverse side effects. The most common side effects were vaginal bleeding and headaches.

 

ABC News

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