Cetero Research, the clinical research organization that fell under regulatory scrutiny for allegedly falsifying clinical trial data, has filed for bankruptcy protection.
The U.S. Food and Drug Administration last July disclosed its inquiry into Cary, North Carolina CRO Cetero, which raised concerns over data and test results over a five-year period. The agency said that pharmaceutical companies who had trials conducted by the CRO needed to review their records to determine whether new tests on their drugs would be required. But the FDA did say that there was no evidence of any safety concerns for products that are already on the market.
Reuters reported that Cetero said in its bankruptcy filing that the FDA’s July 2011 letter caused the company’s “liquidity position to become severely constrained.” Cetero also said that after the regulatory warning, some lenders declared an event of default due to the “apparent violation of applicable health laws and regulations.” Cetero said in the filing that there have been no FDA allegations of fraud against the company.
According to court filings, Cetero’s liabilities totaled about $248 million. Cetero has estimated assets are in the range of $1 million to $10 million. Cetero is now seeking bidders to buy the company or its assets, Reuters reported.
Cetero focuses on early stage clinical research for pharmaceutical companies. The FDA’s initial inquiry focused on data from Cetero’s Houston site collected between April 1, 2005 to June 15, 2010. The FDA later shortened the inquiry time frame by nearly a year, and said that new information collected by the FDA and reported by Cetero means that data after Sept. 1, 2009 was no longer called into question.
Cetero had enlisted a third-party firm to conduct an independent investigation. The FDA subsequently conducted two of its own inspections in 2010. Cetero attributed data discrepancies to six chemists who were seeking overtime pay. But the FDA’s inquiry found time and date discrepancies in at least 875 instances. The agency also said that Cetero falsified data from multiple studies for multiple clinical trial sponsors, which cast doubt on the reliability of other lab records.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
[Photo Credit: Salvatore Vuono]
