FDA finds U.S. drug research firm faked documents

WASHINGTON Tue Jul 26, 2011 6:46pm EDT

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WASHINGTON (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.

"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 regulators said.

Cetero was not immediately available for comment.

(Reporting by Alina Selyukh and Anna Yukhananov; editing by Andre Grenon)

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Comments (3)
robert1234 wrote:
Fake drug testing? To me that’s VERY serious and should result in prison sentences for the guilty parties and withdrawal of the corporate charter.

Jul 27, 2011 1:35pm EDT  --  Report as abuse
robert1234 wrote:
Fake drug testing? To me that’s VERY serious and should result in prison sentences for the guilty parties and withdrawal of the corporate charter.

Jul 27, 2011 1:39pm EDT  --  Report as abuse
hsvkitty wrote:
Immediately stop grants and investigate.

“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.”

This is not all that will be found if they were that complicit in the 4 years prior… this is pure evil.

Investigate and shut them down if you have to… and yes collecting your salary falsly and colluding with rdug companies is fraudulent and stealing Gov money if there were grants (and in 1900 studies you bet there were) then they should be charged with defrauding the Gov as well.

Quick, get in there and seize the evidence before it’s shredded.

Jul 27, 2011 7:12pm EDT  --  Report as abuse
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