What if a drug research firm that is supposed to aid the government in regulating drug companies makes its own decisions and begin falsifying actual results?
Medical research contractor Cetero Research, after two inspections in 2010 and a third-party audit, is now accused of having “significant instances of misconduct and violations,” at least as far as their Houston, Texas branch is concerned.
The U.S. Food and Drug Administration warns that drug companies who have acquired the services of Cetero Research for their clinical studies and drug evaluations may have to do re-evaluations as the FDA has already gathered strong evidences which shows Cetero Research has been “faking documents and manipulating samples.” The firm is responsible for the requirements that drug companies need in their drug approval applications with the FDA like the above mentioned clinical studies and bioanalytics.
The FDA is concerned and alarmed by what they have found out about the drug firm. The government arm has asked drug companies to identify applications they have submitted and approvals that they have received which were made possible with Cetero Research’s aid as the documents they have submitted may have been part of the fraud that the company has committed. This is very important to ensure the drug safety and efficacy of medications that are already in the market, or about to be approved for distribution.
“The pattern of misconduct was serious enough to raise concerns about the integrity of the data Cetero generated during the five-year time frame,” says the FDA in a Reuters report. They are requiring drug applications and approvals made within the period of April 2005 to June 2010 to be re-evaluated.
Cetero has not made any comment on the reports and have yet to issue statements with regards to the FDA’s press releases.