FDA Finds U.S. Drug Research Firm Faked Documents
July 27th, 2011Via: 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.
Research Credit: HPLovecraft666
