Cetero Research, the leading provider of early phase research services, remains fully committed to maintaining the quality and integrity of the data collected in each of its facilities, including the Houston, TX, bioanalytical laboratory. It is this commitment that makes the broad action announced publicly by FDA on July 26, 2011, even more difficult to understand.
Cetero initiated its own internal investigation of its Houston bioanalytical laboratory over two years ago when it discovered the recording of inaccurate day/time data by a small number of research chemists in its Houston facility. Cetero proactively contacted the FDA to self-report its preliminary findings, as well as seek agency feedback on its comprehensive investigation plan.
At that time, Cetero clients were also contacted to make them aware of the situation. The Untitled Letter does not accept the results of our rigorous scientific analysis and discredits the Company’s 1,200 dedicated and experienced employees. The research conducted on behalf of our pharmaceutical sponsors can be, and has been, properly validated.
The FDA said in its public announcement: “It is unlikely that these concerns relating to data integrity affect the overall safety and efficacy of drugs already on the market and, at this time, there is no evidence of problems with the safety, quality, purity or potency of drugs already approved.” Thus, the FDA has not questioned the safety or efficacy of drugs already approved, marketed, and based on data generated from Cetero’s Houston bioanalytical laboratory.
We are pleased that we will now have the opportunity for the first time since our voluntary disclosure was filed in June 2009 to meet with FDA decision-makers to seek to resolve this matter in an appropriate manner. Cetero will continue to cooperate fully with FDA and with our clients and support them through this confusing process.
The little guys are going under the bus! If the FDA had any scientific proclivity they would immediately and randomly audit another group working in the sample group of "the Company’s 1,200 dedicated and experienced employees". As for the narrow window Cetero speaks of in this response, the FDA is looking into a five year period between April 2005 and June 2010.
As noted in a letter FDA sent to the company, Cetero also failed to conduct an adequate internal investigation to determine the extent and impact of the violations and failed to take sufficient measures to assure data integrity within the 5 year time frame.