Drug companies that had medicines tested by a company known as Cetero Research could face product reevaluation - that news according to the FDA after it found that Cetero was faking documents and manipulating samples.
The news is concerning. The FDA report states, "The pattern of misconduct was serious enough to raise concerns about the integrity of the data Cetero generated during a 5 year time frame (April 1, 2005 to June 15, 2010)." Source: http://www.fda.gov/Drugs/DrugSafety/ucm265561.htmFrom the FDA:
The FDA has notified Cetero Research, Houston, Texas (Cetero) of significant violations of federal regulations relating to their conduct of analytical testing of drugs before they are marketed. Cetero is a contract research organization (CRO) that performs bioequivalence and pharmacokinetic testing for pharmaceutical companies; these data are included in New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs).
In addition, FDA is notifying pharmaceutical companies with applications pending before the Agency that testing conducted by Cetero’s Houston facility between April 2005 and June 2010 will need to be evaluated and possibly redone. Given the nature of Cetero’s violative practices, FDA has concerns that the bioequivalence and bioavailability data generated at the Cetero Houston facility from April 1, 2005 to June 15, 2010 may be unreliable. These data are included in New Drug Applications (NDA) and Abbreviated New Drug Applications (ANDA) submitted to FDA.
It is unlikely that these concerns relating to data integrity will affect the overall safety and efficacy of drugs already on the market. FDA is taking this precautionary measure to make sure 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 and marketed.
Stay tuned to this story.
