Cetero Research, the early-phase contract research organisation (CRO) that recently filed for bankruptcy as a means of selling off most of its assets through a ‘stalking horse’ procedure, has reached a final resolution with the US Food and Drug Administration over the disputed bioanalytical studies behind the company’s financial decline.
Last year Cetero was hit by FDA claims of “significant instances of misconduct and violations” at the company’s facility in Houston, Texas.
In a July 2011 letter sent to the CRO, the agency said the problems at Houston raised concerns about the integrity of bioequivalence and bioavailability data generated by the facility between April 2005 and June 2010.
At the same time, and despite Cetero’s insistence that the alleged misconduct was an isolated incident, the FDA informed pharmaceutical companies for which the CRO had conducted bioanalytical studies at Houston between the aforementioned dates that the studies might now have to be repeated or confirmed.
Following “months of open collaboration between Cetero and the FDA”, the company noted in its latest announcement, the agency has now stipulated that:
• It will accept for submission and review studies conducted at Cetero’s Houston laboratory between 1 September 2009 and 15 June 2010, without re-analysis, repetition or further audit by the company or any third party.
• The FDA will accept for submission and review studies performed at the Houston facility between 1 March 2008 and 31 August 2009 if they are accompanied by an independent third-party data-integrity audit. Any studies previously filed as part of an approved or pending regulatory application will also require verification of data integrity through an independent third-party audit.
• Any studies conducted between 1 April 2005 and 28 February 2008, whether they were previously submitted as part of an approved or pending application, or will be submitted as part of a new application, will require complete re-analysis (if stable samples exist) or a repeat of the study.
“From the time Cetero discovered the incident through our own investigation and self-reported the issues directly to the FDA, to the lengthy internal investigation that followed in which updates were regularly provided to the FDA, to the FDA review and recent final resolution, we have taken this matter very seriously,” commented Dr Troy McCall, the company’s chief executive officer.