US FDA warns of data integrity lapses at Cetero
Bioanalytical studies may need to be re-done
Bioanalytical studies conducted by Cetero Research between April 2005 and June 2010 in support of marketing applications may need to be repeated or confirmed, the US Food and Drug Administration has warned.
The warning comes after two FDA inspections at the contract research organisation’s facility in Houston, Texas, carried out in 2010, as well as the company’s own investigation and third party audit, found ‘significant instances of misconduct and violations of federal regulations, including falsification of documents and manipulation of samples’.
The pattern of misconduct was serious enough to raise concerns about the integrity of the data Cetero generated during the five years, the FDA said.
In a letter sent to Roger Hayes, Cetero’s president of bioanalytical, the FDA said ‘objectionable conditions’ were observed at the bioanalytical facility in Houston.
The US regulator is now asking pharmaceutical companies to identify tests conducted by Cetero to support New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs) over the time period in question. They will need to determine whether any of the testing performed by Cetero should be re-done, the FDA said.
The FDA is taking this precautionary measure to make sure that the data underlying the approval decision is completely reliable.
‘At this time, there is no evidence of problems with the safety, quality, purity or potency of drugs already approved,’ the FDA said.
In its response, Cetero claimed this was an isolated incidence of data falsification by a ‘small number’ of research chemists at the Houston facility. The firm said the FDA’s letter does not accept the results of its ‘rigorous scientific analysis and discredits the company’s 1,200 dedicated and experienced employees’.
Cetero said it remains fully committed to maintaining the integrity of the data collected in each of its facilities, including the bioanalytical laboratory in Houston, and it is this commitment that makes ‘the broad action announced publicly by the FDA even more difficult to understand’.
Cetero said it now intends to work closely with the FDA and its clients to resolve the issues raised.
