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【drug-news】FDA批准了避孕药Plan B上市销售
美国食品药品监督管理局继批准避孕药Plan B以非处方药方式销售后，很快就可能迎来两年多来第一位新的长期长官。关于这个紧急避孕药的争论延迟了参议院批准Andrew von Eschenbach担任FDA局长。此前他曾任国家癌症研究所所长。
The so-called Plan B contraceptive, a set of two pills made by Barr Laboratories, contains a drug found in birth control medication that usually prevents pregnancy if taken within 72 hours of unprotected intercourse. In 2003, an FDA advisory committee voted 23-4 in favor of over-the-counter sales of the drug, now available in the U.S. only by prescription. But anti-abortion groups opposed the move, arguing it could lead to promiscuity (Science, 7 October 2005). FDA's failure to make a decision led senators Hillary Rodham Clinton (D-NY) and Patty Murray (D-WA) last March to put a hold on the nomination of von Eschenbach. He has been acting director of FDA since last fall and was concurrently NCI director until June.
所谓的Plan B，是由Barr Laboratories出品的两片装，包括了一种72小时紧急避孕药，即可以在无保护性行为发生72个小时内阻止怀孕。在2003年，FDA顾问委员会以23：4的票数同意了这种药物以非处方的方式销售，现在它仅在美国是一种处方药。但是反堕胎团体反对这次改变，争辩说它将导致男女乱交。FDA迟迟未做出决定导致了参议员Hillary Rodham Clinton和Patty Murray推迟了对von Eschenbach的任命。他自从去年秋天就开始代理FDA局长，并兼任NCI所长直到今年七月。
Today's decision allows sales of the drug to women 18 and older. In a memo, von Eschenbach explained the age cutoff was selected mainly because pharmacies already are accustomed to prohibiting sales of tobacco products to anyone under 18. Although Plan B proponents say younger teenagers should have access, the decision persuaded Clinton and Murray to drop their hold on von Eschenbach's nomination. "[We] hope that he will provide the strong scientific leadership the FDA needs and deserves," they said in a joint statement.
这次的决定允许向年满18岁的女性销售这种药物。在一个备忘录中，von Eschenbach解释说这一年龄选择主要是考虑到药房通常禁止项未满18岁的顾客销售烟草类产品。尽管Plan B的倡议者说青年人本应当有途径买到避孕药，但这个决定还是说服了Clinton和 Murray不再考虑搁置von Eschenbach提名的想法。在一份联合声明中他们说道：“我们希望他能够提供FDA所需和渴望的强烈的科学领导能力。
Outside critics of FDA also see von Eschenbach's decision as a positive sign toward regaining the agency's credibility. "To his credit, [von Eschenbach] took this seriously. ... This clearly begins to set [the agency] back on track," says Kirsten Moore, president and CEO of the Reproductive Health Technologies Project, an advocacy group that supports access to birth control.
来自FDA以外的批评人士也把von Eschenbach的决定视为一种重新赢得这个机构公信力的正面信号。生殖健康技术计划的CEO和主席Kirsten Moore说：“就von Eschenbach的声誉而言，他接下这份工作的态度是严肃的。这也是FDA重回正轨的一个清晰开端。生殖健康技术计划是一个支持避孕的团体。 [标签:content1][标签:content2]
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作者:admin@医学,生命科学 2011-01-19 17:14
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