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Cetero Research, a North Carolina-based early-stage contract research organization, faked documents and manipulated samples, according to three sources: two US Food and Drug administration inspections, an internal company investigation, and a third-party audit. As a result, the FDA has warned that drug companies who have used Cetero’s services may have to reevaluate their results, Reuters reports.
“The inspections and audit identified significant instances of misconduct and violations of federal regulations” at Cetero’s bioanalytical facility in Houston, Texas, the FDA said on Tuesday (July 26). "The pattern of misconduct was serious enough to raise concerns about the integrity of the data Cetero generated during the five-year time frame."
The investigations uncovered nearly 2,000 studies in which the overseeing lab technicians were not present at Cetero facilities at the time those studies were conducted, and possible evidence that the company was neglecting to report failed results or positively “fixing” studies to achieve a desired outcome.
Though the FDA noted that “at this time, there is no evidence of problems with the safety, quality, purity or potency of drugs already approved and marketed,” the agency is notifying companies that have used Cetero-generated data collected between April 2005 and June 2010 in pending regulatory applications that they may need to be “evaluated and possibly redone,” due to the potential unreliability of the results.