The New York Times
reports that, "under pressure from the Food and Drug Administration,"
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 some of 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" when
"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
reports, "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."
reported, "In the past, company officials complained the firm was
'hoodwinked' by investigators, but said they have since made changes."
The Colorado Springs Gazette
reports, "The FDA said it will actively monitor the company and that
the restrictions will remain in place until it is satisfied Coast is
adequately complying with regulations that protect the safety of human
research subjects and that Coast has 15 working days to submit a plan
to bring the company into compliance."
From the American Association for Justice news release.