Described as a potential nightmare for pharmaceutical companies, a Texas-based laboratory has been found by the Food and Drug Administration to have falsified data for clinical trials over a period of five years.

 

The findings by the FDA could mean drug manufacturers will have to re-test some of their products, including those already available to consumers.

 

At issue is the work of Cetero Research in Houston, where from April 2005 to June 2010 lab workers manipulated testing samples and falsified documents, according to two FDA inspections, as well as reviews by Cetero and a third party audit. 

 

Among the examples of misconduct by Cetero, which is based in Cary, North Carolina, was the reporting of nearly 2,000 instances of laboratory technicians conducting certain studies, when in actuality they were not present at the facilities at the time. The FDA also accused Cetero of “the apparent manipulation of equilibration or ‘prep' run samples to meet pre-determined acceptance criteria.”

 

The story broke when an employee complained about falsification of data. Cetero is generally hired by pharmaceutical companies to test their products.

 

The FDA plans to notify drug companies with pending applications to either repeat the bioequivalence testing done by Cetero or retest drug samples using a different test laboratory or contractor. Regulators also want manufacturers with products on the market that used Cetero during the period in question to review the testing that was done by the discredited lab.

-David Wallechinsky

 

FDA Notifies Pharmaceutical Companies that Studies Conducted by Cetero Research May Require Reevaluation (Fierce Biotech)

FDA Finds U.S. Drug Research Firm Faked Documents (Reuters)

FDA Says CRO Studies Should Be Reevaluated (by Ed Silverman, Pharmalot)

Cetero Claims Data Falsification was a One-Off (by Peter Mansell, PharmaTimes)