FDA: DRUG COMPANIES FAKED THOUSANDS OF DRUG DOCUMENTS.

10.5.13 / FAB \FDA – FAKED THOUSANDS OF DOCUMENTS

FDA: DRUG COMPANIES FAKED THOUSANDS OF DRUG DOCUMENTS. 

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According to the Food and Drug Administration, a major drug research contractor has been found faking documents and manipulating samples. The firm, Cetero Research, has tested medicines for major drug companies that are now being forced to reevaluate their products in response to warnings issued by US regulators. The news may be from 2010, but is an example of pharma corruption nonetheless.

Absentee Lab Technicians, Fixed Studies

North Carolina-based Cetero performs early-phase clinical research and bioanalytics for many pharmaceutical companies, which use the results to receive FDA approval for drugs. Exactly which companies used Cetero’s services for FDA drug approval remains unclear, though such companies are being asked by the FDA to come forward.

A series of investigations—two 2010 inspections, an internal company investigation, and a third-party audit—uncovered “significant instances of misconduct and violations” at Houston’s Cetero facility. The FDA adds that “the pattern of misconduct was serious enough to raise concerns about the integrity of the data Cetero generated” between April 2005 and June 2010.

In those five years, laboratory personnel supposedly busy conducting studies were revealed in the investigations as not even being present in the Cetero facilities—in 1,900 instances. The FDA also suspects that Cetero “fixed” studies to skew outcomes or failed to mention others in their reports.

The regulators say that the investigation’s scope is “too narrow to identify and adequately address the root cause of these systemic failures.”

FDA: Drug Companies Faked Thousands of Drug Documents

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