Coast IRB Tells Congressional Committee Sting Operation Was Illegal, Unnecessarily Harmful
The sting is an apparent effort by the Committee to prove that neither the FDA nor the private IRBs it regulates have sufficient checks to confirm the truthfulness of representations made in drug sponsor submissions. The Committee asked GAO to pose as a legitimate clinical trial organization and induce Coast to authorize review of a bogus trial. To cause Coast to believe the clinical trial organization legitimate, the GAO engaged in extensive mail and wire fraud. GAO falsified professional credentials, and submitted a fake medical device protocol. It created a fake medical device, Adhesiabloc, said to be substantially equivalent to another medical device already given market approval by FDA. It submitted fake FDA 510(k) number and fake Federal Wide Assurance number for the device. It engaged in misleading telephone calls and emails. In violation of
Dueber described the fraud as an “elaborate scheme” that worked, at first. Coast IRB approved the clinical trial for review. Then after receipt of a request for production of documents from the Committee, Dueber looked behind the representations made and discovered the fraud, some four months after the trial had been approved.
In his opening statement, Dueber told the Committee that if its “objective . . . was to demonstrate that IRBs need to do more checking and verification . . . we will do that, and we have changed our SOPs to do just that . . . Coast unnecessarily suffered significant harm to its business and business reputation”. “[Y]ou need to understand the effects of this charade. . . My company spent over
For a copy of Dueber’s Opening Statement, report from
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SOURCE Coast IRB