On July 28, Cetero Research ("Cetero"), a contract research organization ("CRO"), responded to FDA's allegations of "a pattern of misconduct" at Cetero's bioanalytics laboratory in Houston, Texas. FDA says it uncovered the wrongdoing during two inspections of the Houston facility. Cetero performs early-phase bioequivalence and pharmacokinetic testing for a number of pharmaceutical companies, which then may use those studies as supporting evidence in drug approval applications to FDA. FDA notified affected pharmaceutical companies via a posting on the FDA website on Wednesday that bioanalytical studies performed at Cetero's Houston laboratory between April 2005 and June 2010 in support of marketing applications may need to be confirmed or repeated.
Specifically, FDA found 1,900 instances over a five-year period from 2005 to 2010 in which laboratory technicians cited for doing research work were not even present at the facility. FDA concluded that Cetero may have fixed its work, omitting any data that it did not like and always delivering desired results to its customers. FDA did say, however, 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, claims Cetero, FDA has not questioned the safety or efficacy of drugs approved based on data generated from its Houston laboratory.
According to Cetero, the company did not engage in any routine falsification of trial data, but rather the discrepancies resulted from six chemists misreporting the date samples were extracted prior to analysis to seek additional compensation through weekend pay and for hours when they did not actually work. Additionally, Cetero initiated an internal investigation over two years ago, and contacted FDA to self-report its preliminary findings regarding these six chemists. At the time it reported its findings to FDA in 2009, Cetero requested feedback from FDA on the nature and scope of Cetero's own investigation plan. FDA did not respond to the request, however, until it sent a letter to Cetero on July 26, 2011 and posted its notification on its website the next day. Due to this lack of communication, Cetero has said it is pleased that it will finally have the opportunity to meet with FDA decision-makers to seek to resolve this issue appropriately.
Cetero maintains that all processes in use at its facilities are state-of-the-art and in full compliance with FDA regulations and bioanalytical industry standards and that all research conducted on behalf of its pharmaceutical sponsors can be, and has been, properly validated. Cetero has also indicated it will continue to cooperate fully with the FDA and with its clients to support them through the process of resolving this issue.