"This misconduct appears to be significant enough to cast doubt on the data generated…If the foundation of the laboratory is corrupt, then the data generated will be also,” according to the auditor. The FDA adds that 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 those five years (you can read the May 2010 and December 2010 inspection reports here and here).
The agency is asking drugmakers to check their databases for trials that were used to support New Drug Applications and Abbreviated New Drug Applications during those years - and to be prepared to repeat or confirm the results. Drugmakers will need to determine whether retesting is required. And those with pending applications will have to repeat bioequivalence testing or retest samples using a different lab (read samples letters here and here). Cetero performed bioequivalence and pharmacokinetic testing.
The FDA has asked Cetero for each study, drug name, study number, and the name of drug sponsors. For the moment, the FDA says it is "unlikely" these "data integrity" failures willl affect the safety and efficacy of drugs on the market and there is no evidence of any problems. But the agency adds that its request that drugmakers review testing is a precautionary measure. This is due to a "pattern of misconduct" over that five-year period.
According to a July 26 letter to Cetero, the FDA is taking this action for three reasons - widespread falsification of dates and times in lab records for subject sample extractions, apparent manipulation of equilibration or ‘prep’ run samples to meet pre-determined acceptance criteria, and a lack of documentation regarding ‘prep’ runs that prevented (Cetero) from conducting an adequate internal investigation to determine the extent and impact of these violations.”
We have asked Cetero to make one of its executives available and will let you know if they agree.