Feds criticized for overruling FDA on Plan B access

A decision to overrule the Food and Drug Administration’s recommendation to expand access to Plan B emergency contraception has drawn criticism locally and nationally.

U.S. Sen. Patty Murray, D-Wash., released a statement saying it was discouraging that Health and Human Services Secretary Kathleen Sebelius decided to go against the FDA’s recommendation to make Plan B One-Step, an emergency contraceptive pill effective at preventing pregnancy when taken within 72 hours of unprotected sex, available over-the-counter to women younger than 17 without a prescription.

“I’m very disappointed that Secretary Sebelius has chosen to override the careful scientific analysis of the FDA by blocking further access to emergency contraception,” she said. “When it comes to the reproductive health of women, I’ve consistently said that we need to put science and medical evidence first.”

Kristen Glundberg-Prossor, a spokesperson in Bremerton for Planned Parenthood of the Great Northwest, said she was surprised Sebelius went against the FDA’s recommendation.

“We were surprised because the science is just really sound that this is a safe and effective drug,” she said.

In 2009, 30 Planned Parenthood health centers in the Northwest region sold 81,938 units of Plan B, Glundberg-Prossor said. Since 50 percent of all pregnancies are unintended, she would like to see Plan B be readily available to everyone who needs it — young or old.

Glundberg-Prossor said 750,000 American teens become pregnant every year. The state Department of Health reports that 55 girls younger than 15 gave birth in Washington state in 2010. There were 38 girls younger than 18 in Kitsap County who had babies in 2010.

“The reality is some teens do become sexually active before they are old enough to purchase Plan B over the counter,” Glundberg-Prossor said.

Sebelius rejected an application by Teva Pharmaceutical Industries Ltd. to allow Plan B to be sold over the counter to women younger than 17. Teva failed to prove that younger girls could understand the drug’s label and use the product appropriately, Sebelius said in a statement.

“It is common knowledge that there are significant cognitive and behavioral differences between older adolescent girls and the youngest girls of reproductive age,” her statement said, noting that many girls are physically able to bear children by age 11.

The move to block expanded over-the-counter access marks the first time a Cabinet secretary has overruled such a decision by the FDA.

Plan B will continue to be available to females 16 and younger with a prescription. Women 17 and older can purchase the drug over-the-counter.

Murray said the FDA’s analysis of Plan B One-Step, which included a review of whether young women understood usage restrictions, was sufficient to make the drug available to all ages over the counter. On Tuesday, Murray along with 13 other senators sent a letter to Sebelius requesting the HHS provide the scientific basis behind her decision to limit the availability of the emergency contraception.

“No one should come between women and the experts that are charged with making impartial, nonpolitical decisions about the safety of the drugs they use,” Murray said.



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