Drug Testing Lab May Have Falsified Results: FDA

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.

Did You Know?

AT&T Data Breach Impacts Millions of Customers

More than 73 million customers of AT&T may have had their names, addresses, phone numbers, Social Security numbers and other information released on the dark web due to a massive AT&T data breach. Lawsuits are being pursued to obtain financial compensation.

Learn More

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.

Tags: Cetero


Share Your Comments

I authorize the above comments be posted on this page*

Want your comments reviewed by a lawyer?

To have an attorney review your comments and contact you about a potential case, provide your contact information below. This will not be published.

NOTE: Providing information for review by an attorney does not form an attorney-client relationship.

This field is for validation purposes and should be left unchanged.

More Top Stories

Johnson & Johnson Faces Medical Monitoring Lawsuit Over Future Baby Powder Cancer Risks
Johnson & Johnson Faces Medical Monitoring Lawsuit Over Future Baby Powder Cancer Risks (Posted yesterday)

Women who used Johnson's Baby Powder around their genitals for feminine hygiene purposes now live in fear of developing ovarian cancer, according to the class action lawsuit seeking medical monitoring for future diagnoses

More Than 9,600 Join Suboxone Lawsuit Over Tooth Decay in MDL Filing
More Than 9,600 Join Suboxone Lawsuit Over Tooth Decay in MDL Filing (Posted 2 days ago)

A bundled complaint of about 9,600 Suboxone lawsuits were filed in federal court on Friday, ahead of the two-year anniversary of the FDA requiring tooth decay label warnings on the opioid treatment film strips, which is also a deadline for filing a civil complaint in many states.