Company that Approved Fake Medical Trial Sanctioned by FDAApr 15, 2009 | Parker Waichman LLP
U.S. regulators have acted against Coast IRB, a human medical study review firm that approved a clinical trial for a fake medical device that was part of a federal investigation. According to the Food & Drug Administration (FDA), the Colorado Springs, Colo., firm agreed to stop reviewing new experiments and also halt enrollment in research trials already under way.
As we reported last month, Coast IRB is an independent company that is paid by drug and device makers to insure the safety of humans in trials involving medical products. Under current federal law, clinical research involving human subjects and FDA-regulated products, such as drugs, biologics or medical devices, must have the review and approval of an “institutional review board” (IRB). An IRB is a panel of doctors, scientists and non-scientists charged with reviewing the clinical research to protect the rights and welfare of the subjects participating in the study. Historically, such reviews have been done by academic review boards, but increasingly medical device and drug makers are relying on boards run by firms like Coast IRB.
During a "sting" operation run by the Government Accountability Office (GAO), a Coast IRB private review panel unanimously approved a fake medical protocol for testing which called for a full liter of a fictitious product to be poured into a woman’s stomach after surgery. Coast IRB’s minutes of the approval meeting showed that board members thought the protocol was “probably very safe." According to the GAO, the Coast IRB approval came after two other private boards rejected the protocol. One called it “junk”, while a member of another board said it was the “riskiest thing I’ve ever seen on this board."
In response to the GAO investigation, the FDA sent Coast IRB a warning letter. Until further notice, Coast IRB has agreed to stop reviewing new FDA-regulated studies, the agency said. Also, Coast IRB will direct clinical investigators in on-going FDA-regulated studies approved by Coast IRB to halt new subject enrollment. These restrictions will remain in effect until the FDA is satisfied that Coast IRB has taken necessary corrective actions that bring it into compliance with FDA regulations designed to protect human research subjects.
According to Coast IRB's records, these actions may involve approximately 300 active human research studies conducted by some 3,000 clinical investigators.
Because of the potential risk to enrolled subjects and disruption to the research if on-going studies were abruptly terminated, the FDA said studies that Coast IRB has already approved will be permitted to continue. However, no new subjects will be permitted to enroll in these studies until there is assurance that the research has undergone adequate review. Coast IRB continues to be obligated to receive and respond to reports of unexpected and serious adverse events as well as to review progress reports submitted by clinical investigators, the agency said.
The FDA said it will continue to actively monitor Coast IRB and take appropriate action as necessary.