Right-leaning organizations praised Ms. Sebelius's decision

The move inserted the Obama administration into the long-running controversy over how much the federal government should restrict access to Plan B, a so-called morning-after pill that can stop pregnancy up to three days after intercourse.moncler jackets Allowing girls under age 17 to buy the $50 pill over the counter could have saddled the Obama administration with a political target as the 2012 presidential campaign moves into full swing. FDA Commissioner Margaret Hamburg was ready to approve a request by the drug's manufacturer, Teva Pharmaceutical Industries Ltd., to remove the current requirement that girls under age 17 need a prescription for the drug. She said the agency found it to be "safe and effective in adolescent females," and that younger women could properly use the drug without the intervention of a doctor. But Health and Human Services Secretary Kathleen Sebelius on Wednesday said she was overriding the decision, saying the data submitted did not prove it was appropriate for girls to take Plan B without a prescription. Ms. Sebelius, in a letter to Ms. Hamburg, appeared uncomfortable with making the product available to young girls, and noted that 10% of females reach reproductive age by 11 years old. "It is commonly understood that there are significant behavioral and cognitive differences between older and adolescent girls and the youngest girls of reproductive age which I believe are relevant to making this determination," Ms. Sebelius wrote. Although the HHS secretary has the legal authority to overrule FDA decisions, an FDA spokeswoman said the agency couldn't find another example of it. An HHS spokeswoman wouldn't comment on whether the White House was involved in the move but said "today's decision is the secretary's decision." Teva submitted two studies to support approval of its application to fully lift prescription requirements for Plan B. One study looked at whether adolescents could understand the drug's label. The second involved 345 girls ages 11 to 17 that was designed to simulate real-world use of the product. Amy Niemann, a Teva vice president, said nearly 90% of the girls were able to properly use Plan B. The full study results haven't been made public. Ms. Sebelius said the label comprehension and actual-use study didn't include data "on all ages for which the drug would be approved and available over-the-counter." However, Ms. Hamburg said the FDA reached a different conclusion and said its internal drug-review experts—which included pediatricians and obstetricians—"reviewed the totality of the data and agreed...it should be approved for all females of childbearing potential." It appears Ms. Sebelius's decision came at the last minute. The FDA was ready to approve Teva's request by a Wednesday deadline but was ordered the same day to reverse the decision. The debate over Plan B is in many ways a proxy for broader social issues such as abortion and parental notification. The drug works by using high doses of the female hormone progestin, which also is contained in birth-control pills, to block a potentially fertilized egg from becoming implanted in a woman's uterus. Some doctors are unwilling to prescribe the drug and some pharmacists won't sell it. Had the request been approved, Plan B would have been available in drugstore aisles, instead of behind the pharmacy counter. Women 17 and older will remain able to buy it without a prescription. Left-leaning women's health advocates seized on the ruling to accuse the Obama administration of allowing politics to interfere with a decision the FDA typically makes based on scientific evidence. "We are outraged that this administration has let politics trump science," said Kirsten Moore, chief executive of the Reproductive Health Technologies Project, Moncler jackets for women, cheap moncler women down jackets on sale an advocacy group. "There is no rationale for this move." The Center for Reproductive Rights sued the FDA in 2005 over its decision-making process involving Plan B. Nancy Northup, president of the liberal advocacy group, said Wednesday it sued the Bush administration for "rejecting science and playing politics with women's health by denying emergency contraception for over-the-counter sale. We are stunned to see the same behavior from the Obama administration." Rep. Diana DeGette (D., Colo.), a vocal advocate for women's health in Congress, said that the "FDA's review process was clearly extensive and thorough, and the data shared with HHS made clear that Plan B is safe and effective for its intended use." Right-leaning organizations praised Ms. Sebelius's decision. Jeanne Monahan, a director of the Family Research Council, a conservative Christian group, said that making the drug available without a prescription would have "bypassed necessary routine medical care for sexually active girls." "There is a real danger that Plan B could be given to young women, especially sexually abused minors, under coercion or without their consent," Ms. Monahan said. "Interaction with medical professionals is a major screening and defense mechanism for victims of sexual abuse." Teva's Ms. Niemann said in an interview last week that the company was seeking approval to lift the prescription age requirement so teens and women of all ages would have fast and easy access to Plan B. The company said it was disappointed with HHS's decision. Plan B has been controversial since 1999 when it first was approved as a prescription-only drug. In 2003, an FDA advisory panel voted to lift the prescription requirement, but in 2004 the FDA went against its panel's advice and kept the requirement in place. In 2006, the FDA decided to allow Plan B to be sold without a prescription to women age 18 and older. Three years later,giubbotti moncler it dropped the age to 17 as part of a federal court ruling on the issue. The judge in the ruling said that FDA's upper management "wrestled control" from FDA staff, who normally would decide whether to allow a drug to be switched from prescription to nonprescription status, and made a decision to reject the application at "the behest of political actors."