WASHINGTON (AP) â" The U.S. health secretary stopped a Plan B morning-after tablet from relocating onto drugstore shelves subsequent to a condoms, last in a warn pierce Wednesday that immature girls should not be means to buy it on their own.
The Food and Drug Administration was scheming to lift a argumentative age extent and make Plan B One-Step a U.S.'s initial over-the-counter puncture contraceptive, accessible for squeeze by people of any age though a prescription.
But Health and Human Services Secretary Kathleen Sebelius intervened during a eleventh hour and overruled her possess experts.
Plan B instead will sojourn behind a pharmacy counter, as it is sole currently â" accessible though a medication usually for those 17 and comparison who uncover an ID proof their age.
Sebelius' reason: Some girls as immature as 11 are physically able of temperament children, and Plan B's Jerusalem-based builder did not infer that younger girls could scrupulously know how to use this product though superintendence from an adult.
"It is common trust that there are poignant cognitive and behavioral differences between comparison youth girls and a youngest girls of reproductive age," Sebelius pronounced in a statement. "I do not trust adequate information were presented to support a focus to make Plan B One-Step accessible over-the-counter for all girls of reproductive age."
It was a latest turn in a scarcely decade-long pull for over-the-counter sales of pills that can forestall pregnancy if taken shortly adequate after defenceless sex. Major doctors' groups and women's health advocates contend easier, quicker entrance to those pills could cut a nation's high series of random pregnancies.
The preference repelled builder Teva Pharmaceuticals, that had been gearing adult for over-the-counter sales to start by month's end, and women's health groups.
"We are angry that this administration has let politics trump science," pronounced Kirsten Moore of a Reproductive Health Technologies Project, an advocacy group. "There is no motive for this move."
"What else can this be though politics?" pronounced Cynthia Pearson, executive executive of a National Women's Health Network, an advocacy organisation that supports creation Plan B accessible to all ages. "It's not science. It's not medicine. It's not women's health."
Indeed, FDA Commissioner Dr. Margaret Hamburg done transparent in her possess matter that a preference is rarely unusual. She pronounced her agency's drug-safety experts had delicately deliberate a doubt of immature girls and that she had concluded that Plan B's age extent should be lifted.
"There is adequate and reasonable, well-supported and science-based justification that Plan B One-Step is protected and effective and should be authorized for nonprescription use for all females of child-bearing potential," Hamburg wrote.
But, she added, she had followed her boss' sequence to repudiate Teva's application.
"We praise a FDA for creation a recommendation ... and we are unhappy that during this late date, a Department of Health and Human Services has come to a opposite conclusion," pronounced a matter Teva released Wednesday.
The association pronounced it would examination a preference before last subsequent steps.
Already, a FDA's age boundary have left to court. In 2009, a sovereign decider pronounced a group had set them primarily formed on politics, not science, and systematic a group to reconsider. A conference already was scheduled for subsequent week to cruise either a FDA should be hold in disregard of justice for not doing so earlier.
News referensi http://news.yahoo.com/us-health-official-says-no-young-teens-pill-190822964.html
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7:30 PM Thursday, December 15, 2011