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【技术产业】美国会议员抨击FDA监管临床试验不
By Justin Blum
March 11 (Bloomberg) -- The Government Accountability Office should investigate delays by U.S. drug regulators in disciplining researchers who break rules while testing drugs in people, lawmakers said.
Republican Representatives Joe Barton of Texas and John Shimkus of Illinois wrote a letter today to the GAO, the investigative arm of Congress, saying the Food and Drug Administration's oversight of clinical trials needs to be reviewed ``thoroughly.''
The lawmakers' letter cited a Feb. 29 Bloomberg News report that said the FDA failed to complete disciplinary action against 12 researchers after proposing that they be disqualified from trials based on findings that they violated agency rules to protect patients and ensure accurate data. Cases have remained unresolved for as long as a decade, allowing researchers to work on more studies.
``FDA has waited months and sometimes years to take action against doctors who lied about their work on critical clinical studies of new drugs and who put their own patients at risk,'' Barton said in a statement. ``There's just no excuse for not invoking the authority FDA already has to rapidly disqualify liars from taking any further role in these drug studies.''
Barton is the top Republican on the House Energy and Commerce Committee, which oversees the FDA, and Shimkus is the top Republican on the panel's Oversight and Investigations Subcommittee.
The GAO likely will investigate the matter, though a formal decision won't be made until next week, said Marcia Crosse, the accountability office's director of health-care issues, in an interview.
`Effective Oversight'
In addition to investigating delays, the lawmakers' letter asked the GAO to examine whether the FDA's oversight is ``effective in identifying clinical investigators whose practices or conduct may compromise the quality and integrity of clinical data or the safety of participants in clinical trials.''
The Bloomberg News story described the case of James C. Vestal, a Texas doctor who the FDA said submitted falsified data from a drug trial and enrolled patients who should have been excluded for safety reasons. Agency investigators wrote a report on Vestal and then the FDA took more three years to begin the disciplinary process, allowing Vestal to work on additional trials.
Vestal's case remains pending and he has voluntarily agreed not to do any additional studies while his lawyer negotiates with the FDA. Vestal and his Washington lawyer, Philip Katz, have declined to comment.
The FDA recognizes the disciplinary process needs improvement and is developing timelines to regulate how long it takes to punish those who violate its drug-test rules, agency officials have said. 本人认领此篇翻译,48小时内出结果,此后请各位战友可以自由认领 Drug Trial Oversight Needs U.S. Probe, Lawmakers Say (Update1)
国会议员们认为：美国国会应当调查药品临床试验的监管情况
By Justin Blum
March 11 (Bloomberg) -- The Government Accountability Office should investigate delays by U.S. drug regulators in disciplining researchers who break rules while testing drugs in people, lawmakers said.
3月11日（彭博资讯）一些国会议员认为：政府问责办公室应当对美国药品监管部门对违规进行临床试验的研究人员处罚不力的事情进行调查
Republican Representatives Joe Barton of Texas and John Shimkus of Illinois wrote a letter today to the GAO, the investigative arm of Congress, saying the Food and Drug Administration's oversight of clinical trials needs to be reviewed ``thoroughly.''
德州的共和党议员Joe Barton和伊利诺斯州的议员John Shimkus今天给政府问责办公室（美国国会的调查机构）写了一封信，认为应当对FDA对临床试验的监督情况进行彻底的调查。
The lawmakers' letter cited a Feb. 29 Bloomberg News report that said the FDA failed to complete disciplinary action against 12 researchers after proposing that they be disqualified from trials based on findings that they violated agency rules to protect patients and ensure accurate data. Cases have remained unresolved for as long as a decade, allowing researchers to work on more studies.
议员们在信中引用了彭博资讯的有关报道，报道中说：FDA没能对12名科研人员进行相应的处分，这12人涉嫌有违被有关保护患者安全和试验数据准确的规定的行为。这类案件有的已经长达十年仍没有得到解决，涉案人员依然在进行临床医学研究。
``FDA has waited months and sometimes years to take action against doctors who lied about their work on critical clinical studies of new drugs and who put their own patients at risk,'' Barton said in a statement. ``There's just no excuse for not invoking the authority FDA already has to rapidly disqualify liars from taking any further role in these drug studies.''
Barton议员在一份声明中指出：FDA对一个涉嫌在新药临床试验中违法规定导致患者危险增加的科研人员的处罚可能需要几个月，甚至几年的时间。我们没有理由不要求作为监管部门的FDA，快速对那些违反规定的说谎者进行处理，使他们不能再参与药品临床试验。
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作者:admin@医学,生命科学 2011-03-21 05:14
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