The Food and Drug Administration has notified pharmaceutical companies that hired contract research organization Cetero Research of Houston, Texas that the work done by Cetero may need to be redone or confirmed. The alert to pharmaceutical companies follows an FDA letter sent yesterday to Cetero identifying problems in the company’s research, including falsification of entries on lab records and manipulation of samples to meet predetermined acceptance criteria.
In the letter, FDA spelled out what it calls “objectional conditions” at Cetero during inspections held 3-7 May 2010, which the agency says violate the bioavailability and bioequivalence requirements in the Code of Federal Regulations. The problems cover studies done between 1 April and 15 June 2010 and include:
(1) The widespread falsification of dates and times in laboratory records for subject sample extractions; (2) the apparent manipulation of equilibration or “prep” run samples to meet predetermined acceptance criteria; and (3) the lack of documentation regarding equilibration or “prep” runs that prevented you from conducting an adequate internal investigation to determine the extent and impact of these violations.
The agency is asking drug company sponsors to identify those tests conducted by Cetero during the designated time frame that were used to support FDA drug applications, and determine if any of the tests need to be redone. FDA also plans to ask drug sponsors with pending applications to either repeat the bioequivalence testing done by Cetero or retest drug samples with a different test laboratory or contractor.
Cetero has 15 working days to respond to the letter, providing FDA with a list of all studies related to FDA-regulated research conducted between 1 April and 15 June 2010, identifying each drug sponsor. Cetero is also required to explain the steps being taken to correct the violations prevent their recurrence.
UPDATED: 27 July 2011, 6:04 pm. A spokesperson for Cetero Research sent Science Business the following statement a few minutes ago …
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.
Hat tip: Fierce Biotech
Photo: Håkan Dahlström/Flickr
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