Bankrupt Cetero Redoing Studies For Some Drugmakers?

Bankrupt Cetero Redoing Studies For Some Drugmakers?

April 20th, 2012 // 12:54 pm @

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Last summer, the FDA alerted the pharmaceutical industry that any clinical tests conducted between April 2005 and June 2010 by a contract research organization called Cetero Research may have to be reevaluated because two agency inspections and an outside audit found falsified data and manipulated samples (back story). So which companies need to have studies reworked?

The list is out, thanks to a bankruptcy court filing. The FDA notice, you may recall, put a strain on Cetero finances because lenders viewed its problems as a breach of “applicable health laws and regulations” that amounted to a default on its loans (see here). And so, if you turn to page 51 of this document, nearly two dozen drugmakers are listed.

The drugmaker with the largest exposure is Teva Pharmaceuticals, which has eight separate contracts noted. Others include Ranbaxy Laboratories, Actavis and CorePharma. The work is mostly Phase I testing designed to show eqiuvalency with brand-name meds. Specific drugs, however, are not mentioned, suggesting the possibility that questions may linger about the veracity of various pharmaceuticals. We have asked Teva for a comment and will update you accordingly.

[UPDATE: A Teva spokeswoman wrote us to say the “vast majority” of the reworked studies will be completed by August. And she then referred us to this FDA statement: “Concerns related to data integrity will not likely 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. As a precautionary measure, however, the FDA is asking drug sponsors to review the testing in question conducted by Cetero to make sure that data are completely reliable.”]


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