Alleged misconduct at Cetero’s laboratory in Houston, Texas has been the focus of internal and external investigations for more than two years. After receiving unsatisfactory responses to two 2010 inspections, the US Food and Drug Administration (FDA) has gone public with the investigation.
“The pervasiveness and egregious nature of the violative practices by your firm has led FDA to have significant concerns that the bioequivalence and bioavailability data generated at the Cetero Houston facility from April 1, 2005, to June 15, 2010”, said the regulatory agency in a letter to the CRO.
A Cetero employee told the FDA “equilibration or “prep” runs were allegedly used to manipulate data by “fixing” runs to meet acceptance criteria prior to inclusion of data in the official study folder”.
Also, an internal investigation by Cetero found 1,900 cases in which samples were allegedly taken on weekends or holidays but chemist arrival times were more than one hour after the extraction. Cetero said this was so employees received weekend work “financial incentives” but the FDA disagrees.
“You have not provided an explanation regarding why employees would have falsified the dates and times on weekday records, as there was no financial incentive for them to do so”, said the FDA.
At this stage it is unclear which sponsors and products could be affected but Cetero and the FDA agree “falsifications involve data from multiple studies for multiple sponsors”. Certero runs clinical trials for leading innovator and generic companies and is listed in 122 studies on ClinicalTrials.gov.
The bioanalytical laboratory in Houston will support some of these studies, with Cetero’s site in Ontario, Canada and third-party facilities handling the rest. Companies potentially impacted by activities at the Houston laboratory are being contacted by the FDA.
Cetero has traditionally been focused on the generics industry, performing trials for Sandoz, Teva, Mylan and Actavis, but wants innovator clients to make up the bulk of its business. This strategic shift has seen it perform clinical trials for Pfizer, Bristol-Myers Squibb, Novartis and AstraZeneca.
An investigation into Cetero began after an employee raised formal allegations of regulatory violations and other misconduct. The employee claims to have first voiced concerns to management, including former CEO Jerry Merritt, in a June 2007 supervisor meeting.
Cetero began an internal investigation after the employee’s formal complaint in April 2009. In June 2009 the employee notified the FDA of alleged misconduct and shortly after Cetero also told the agency about its internal investigation.
In January the FDA said its fraud unit was investigating a contract laboratory. At the time the FDA said it was also investigating: trial document falsification by a study coordinator; fraud associated with current good manufacturing practices (cGMP); and three cases related to drug promotion.