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Ah... It's a profit deal. Takes the pressure off...
WASHINGTON | Tue Jul 26, 2011 6:46pm EDT
(Reuters) - Drug companies that had medicines tested by contractor Cetero Research might have to reevaluate results, U.S. regulators warned after the firm was found faking documents and manipulating samples.
The Food and Drug Administration said on Tuesday two 2010 inspections, an internal company investigation and a third-party audit uncovered "significant instances of misconduct and violations" at a Cetero facility in Houston.
The Cary, North Carolina-based firm does early-phase clinical research and bioanalytics for a number of drugmakers. The pharmaceutical companies can then use those studies as supporting evidence in drug approval applications to the FDA.
"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, warning drugmakers they might have to repeat or confirm any studies Cetero did in support of their applications between April 2005 and June 2010.
It remains unclear which drugmakers have used Cetero's services to apply for regulatory approvals and the FDA is asking companies to identify such instances. The regulators said the measure is precautionary and the safety and efficacy of drugs already on the market are unlikely to be affected.
The FDA inspected Cetero in May and December last year and found falsified records about studies.
Specifically, in at least 1,900 instances between April 2005 and June 2009, laboratory technicians identified as conducting certain studies were not actually present at Cetero facilities at that time, the FDA said in its May report.
The FDA also said at the time that Cetero might have "fixed" studies to get the desired result, or did not include failed results in their report.
Any drug developers which relied on Cetero Research for early-stage research or bioanalytics may have a real problem on their hands. The FDA says that two inspections of its Houston lab in 2010 revealed a "pattern of misconduct" that raised serious questions about the research work the CRO carried out between April 2005 and June 2010. And some developers may be required to pay for a do-over in order to keep the FDA's seal of approval.
Regulators going over the books found 1,900 instances over a 5-year period in which the lab technicians cited for doing research work weren't even in the facility. That led the FDA to conclude that Cetero may have fixed its work, punting any data it didn't like and ensuring it delivered desired results. And even though the agency says it's unlikely there are any safety issues, sponsors with approved products or pending applications are being asked for confirmation of their results or a repeat of the work.
That could affect a long lineup of companies. On its website, Cetero boasts that it completes 750 studies a year, with on-time startups 99% of the time.
The FDA concurred with Cetero's independent auditor, who stated: "This misconduct appears to be significant enough to cast doubt on the data generated...If the foundation of the laboratory is corrupt, then the data generated will be also."
"FDA has reached this conclusion for three reasons: (1) the widespread falsification of dates and times in laboratory records for subject sample extractions, (2) the apparent manipulation of equilibration or 'prep' run samples to meet pre-determined acceptance criteria, and (3) lack of documentation regarding ‘prep' runs that prevented you from conducting an adequate internal investigation to determine the extent and impact of these violations."