Wednesday, April 15, 2009

Under Pressure From FDA, Independent Review Board Suspends Study Reviews

The New York Times reports that under pressure from the FDA, Coast Independent Review Board of Colorado Springs "got a dose of reality" when it "agreed to temporarily suspend approving federally regulated medical studies or enrolling new patients in ones currently under way." The move may affect about 300 active studies involving human patients that Coast currently oversees on behalf of makers of drugs or medical devices. In the previous month, "Coast first embarrassed itself, then became a Congressional whipping boy" after "undercover federal investigators prepared plans for a sham medical study involving a make-believe surgical product" and non-existent doctors. Coast approved the study."

The Wall Street Journal reported "The FDA on Tuesday sent the company a formal warning letter about violations of IRB guidelines. The FDA described it as the largest shutdown of IRBs in the agency's history." According to Leslie Ball, director of scientific-investigations compliance in the FDA's drug division, "the agency asked Coast to stop some aspects of its reviews 'due to serious concerns the FDA has about Coast's ability to protect human subjects.'" A statement by Coast said "it is cooperating fully with the FDA and is undertaking sweeping overhauls 'to ensure maximum protection for human subjects.' It said it plans to put in place a new board chair and new board members."

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