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FDA policing researchers enough?
Not to be outdone by Democrats calling for pharma-related investigations by the Government Accountability Office, two Republican Congressmen are asking the GAO to probe the FDA's methods for disciplining researchers who break drug-trial rules. Rep. Joe Barton and John Shimkus wrote a letter to the government auditor, saying that FDA oversight of trials needs to be reviewed.
Barton alleged in a statement that the FDA "has waited months and sometimes years to take action against doctors who lied about their work" and suggests that the agency should use its authority to disqualify any "liars" from participating in drug studies. The two men also want the GAO to determine whether the FDA does enough to identify researchers "whose practices or conduct may compromise" trial data.
- see the item at Pharmalot
Related Articles:
Are researchers facing FDA crackdown on trial fraud? Report
Report: FDA lax in clinical trial oversight. Report
FDA reviews new rules for clinical trials. Report
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