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【社会人文】议会敦促FDA安全改革
09 Oct 2006 21:55:35 GMT
Source: Reuters
By Lisa Richwine
WASHINGTON, Oct 9 (Reuters) - Editors at a major medical journal and members of a drug-safety advisory panel joined calls on Monday for major changes to improve the U.S. Food and Drug Administration's oversight of medicines on the market.
A New England Journal of Medicine editorial urged the U.S. Congress to adopt recommendations made by an Institute of Medicine (IOM) panel last month to bolster drug safety. The IOM report pressed Congress to give the FDA more staff, funding and power -- including the ability to require the drug industry to do post-approval studies and change warning labels.
"We face a mounting public health crisis in drug safety, and definitive action must be taken ... The IOM committee's report is a crucial starting point," the editors wrote.
They also appealed for an end to "a growing politicization" of the FDA in recent years.
Concern about side effects from prescription drugs intensified after Merck & Co Inc. <MRK.N> withdrew arthritis drug Vioxx in September 2004 because of a link to heart damage. Critics said the FDA should have reacted sooner to signs of problems related to Vioxx and other medicines on the market.
In another medical journal, five current or former members of the FDA's Drug Safety and Risk Management Advisory Committee also urged lawmakers to fix many of the problems the IOM and others identified.
Along with more funding for FDA drug-safety programs, the experts from outside the agency suggested a time-limited "conditional approval" for some drugs that would require additional tests.
"It is now up to Congress to take the steps necessary to reinvigorate the FDA's ability to assure the public that approved medical products are safe," Dr. Curt Furberg and others wrote in the Archives of Internal Medicine.
Congress must pass legislation next year to renew industry fees that help fund drug reviews, and that bill could be a vehicle for addressing drug safety issues.
Furberg and his co-authors backed a plan put forth in a Senate bill for a drug safety center within the FDA that would handle post-approval tracking of side effects and be separate from pre-approval drug reviews.
Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research, said on Monday such separation would "really exacerbate the problem" by making it more difficult for pre- and post-approval reviewers to work together.
"What we need is better science and more resources and mechanisms to improve the way that we work together," Galson said in an interview.
Galson and other top FDA officials previously have said they already are taking steps to strengthen drug safety monitoring and are considering the suggestions in the IOM report, which the agency requested. 本人已认领该文编译，48小时后若未提交译文，请其他战友自由认领。 Congress urged to act on US FDA safety reforms
议会敦促FDA安全改革
09 Oct 2006 21:55:35 GMT
Source: Reuters
格林尼治标准时间2006年10月9日21:55:35
消息来源：路透社
By Lisa Richwine
Lisa Richwine报道
WASHINGTON, Oct 9 (Reuters) - Editors at a major medical journal and members of a drug-safety advisory panel joined calls on Monday for major changes to improve the U.S. Food and Drug Administration's oversight of medicines on the market.
10月9日在华盛顿（路透社）主要医学杂志的编辑和药品安全咨询讨论小组于星期一联合号召美国食品药品监督管理局（FDA）进行改革以加强其对市场药品的监管。
A New England Journal of Medicine editorial urged the U.S. Congress to adopt recommendations made by an Institute of Medicine (IOM) panel last month to bolster drug safety. The IOM report pressed Congress to give the FDA more staff, funding and power -- including the ability to require the drug industry to do post-approval studies and change warning labels.
英国医学杂志的一篇评论敦促美国议会采纳上个月医学研究院（IOM）讨论小组所作出的加强药物安全性的建议。IOM报告要求议会给FDA委派更多的人手，提供更多的资金和力量——包括有权力要求制药企业进行核准后研究并改变警告标记状态。
"We face a mounting public health crisis in drug safety, and definitive action must be taken ... The IOM committee's report is a crucial starting point," the editors wrote.
编辑们写道“我们在药物安全性方面面临着越来越多的公共健康危机，必须采取确定的行动……IOM委员会的报告是一个关键性的起点。”
They also appealed for an end to "a growing politicization" of the FDA in recent years.
他们还呼吁FDA在近几年结束越来越多的政治活动。
Concern about side effects from prescription drugs intensified after Merck & Co Inc. <MRK.N> withdrew arthritis drug Vioxx in September 2004 because of a link to heart damage. Critics said the FDA should have reacted sooner to signs of problems related to Vioxx and other medicines on the market.
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