Cetero Research, the clinical research organization that fell under a U.S. Food and Drug Administration probe for allegedly falsifying clinical trial records, has reached a “final resolution” with regulators about which studies can stand and which ones must be redone.
The FDA had raised questions about data from Cetero’s Houston bioanalytical laboratory over a five-year period that ended June, 15 2010. Since that inquiry became public last summer, the Cary, North Carolina-based CRO has been working with the agency to sort out the studies while trying to also coordinate a sale of the company. Financial constraints on the company in the wake of the FDA investigation ultimately led to a Cetero bankruptcy protection filing.
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Cetero focuses on early phase clinical research. The FDA’s Cetero inquiry became public last July after the agency issued a notice to pharmaceutical companies warning that companies who had clinical trial work done by Cetero may need to do those tests again.
A list of the nearly two dozen pharma companies that need to do retesting was filed with Cetero’s bankruptcy documents. No specific drugs are identified in the filing or by the FDA. The FDA’s review has concluded the earliest studies in the questioned five-year period are the ones that must be reanalyzed or in some cases, completely redone. The more recent studies can stand. According to the notification sent to pharmaceutical companies, here’s how it breaks down:
Between Sept. 1, 2009 and June 15, 2010: The FDA will accept studies without reanalysis, repeating or further audit by Cetero or another party.
Between March 1, 2008 and Aug. 31, 2009: The FDA will accept studies only if they are accompanied by an independent third-party data integrity audit. Also, previously submitted studies as part of an approved or pending drug application will also need an independent third-party audit.
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Between April 1, 2005 and Feb. 28, 2008: These studies, whether they were previously submitted or will be submitted as part of an application, will need complete reanalysis if stable samples exist. If not, the study must be repeated.
Pharmalot reported earlier that court documents show that the pharma company with the largest exposure is Teva Pharmaceuticals, which has eight contracts. Other companies affected include Ranbaxy Laboratories, Actavis and CorePharma. Most of the listed companies focus on generic drugs. A Teva spokeswoman told Pharmalot that the “vast majority” of the reworked studies will be completed by August. But by then, Cetero could be in the hands of new owners. Cetero’s bankruptcy reorganization plans call for a sale of the company under a stalking horse bidding process in which the company’s secured lenders set a floor price for other bidders to top. A sale could be completed sometime in May.
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