Federal drug regulators are warning pharmaceutical companies that a major drug testing lab may have faked the results of some of its tests.
Last week, the FDA indicated that pharmaceutical companies may have to have some pending drugs retested, because it appears that Cetero Research, a major drug testing lab, could have falsified results. The FDA said the tests were used to support applications for new drugs, but the results that were falsified do not appear to bring into question the safety or efficacy of those drugs.
The FDA is sending letters (pdf) to pharmaceutical companies that may have been affected by the allegedly falsified tests, but has not identified any specific companies or drugs that may have used Cetero. The federal regulatory agency is telling drug makers that they should review any testing done by Cetero, and consider getting those drugs reevaluated as a precautionary measure.
Cetero Research, based in Houston, Texas, is accused of faking studies in order to get the desired results for their clients. Between April 2005 and June 2010, there were at least 1,900 instances where Cetero claimed that laboratory studies were conducted by certain laboratory technicians that FDA inspectors later discovered were not actually present.
The discrepancies were discovered in 2010 by two FDA inspections, as well as a third-party audit and Cetero’s own internal investigation. The company now faces FDA claims of misconduct and violation of federal regulations, including falsification of documents and manipulating drug samples. The FDA sent a letter to the company(pdf) on July 26, outlining the accusations.
Cetero released a statement (pdf) emphasizing the FDA’s statement that the safety and effectiveness of the drugs it tested did not appear to be in question. The company claims that it started its own internal investigation more than two years ago and found that six chemists misreported dates in order to put extra time on the clock so that they could earn overtime pay.
The company says that the laboratory is currently in full compliance with FDA regulations and industry standards.