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Drug Companies Sent Scramble after Research Firm Accused of Falsifying Docs

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Pharmaceutical companies that contracted with a medical research contractor to test their medicines might need to reevaluate their results. Two 2010 inspections, an internal investigation and a third-party audit revealed that a Cetero Research facility in Houston was faking documents and manipulating samples, said the U.S. Food & Drug Administration (FDA), reported Reuters.

Cetero performs early-phase clinical research and bioanalytics for several pharmaceutical companies, and those study results are often used as supporting evidence in drug approval applications to the FDA.

Following their investigation in May and December of last year, the FDA found “significant instances of misconduct and violations” at the Houston facility.

The agency uncovered that Cetero falsified their records, specifically, at least 1,900 instances between April 2005 and June 2009, laboratory technicians conducting studies were actually not present at the medical research facility, reported Reuters.

The FDA also believes that Cetero “fixed” studies to guarantee a certain result or did not include failed results in their report.

“Cetero’s May 2010 and December 2010 responses are inadequate because the scope of their internal investigation was far too narrow to identify and adequately address the root cause of these systemic failures,” the agency said.

Now study results tested by Cetero and submitted in approval applications between April 2005 and June 2010 may need to be re-tested or confirmed.

“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 FDA said.

The FDA is not sure what companies contracted with Cetero to apply for approvals, but as a precautionary measure the agency is urging drug makers to step forward.

According to the FDA, the safety and efficacy of drugs already on the market are unlikely to be affected.

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