We will now look at some of the consequences of unreliable laboratory data for the laboratory or organisation.

Able Laboratories

Able Laboratories was forced to suspend production of, and recall all of its products from the market. With no production and no products it was able to sell, the company’s value fell by over 85 %, by the end of 2005 Able Laboratories had sold its assets to Sun Pharmaceuticals.

Leiner Health Products

Leiner Health Products was convicted of one count of fraud and was fined $10 million, the company filed for chapter 11 bankruptcy protection in March 2008 and was taken over by NBTY Inc. in June of 2008.

Ranbaxy

More recently in January of 2012 Indian generic drug manufacturer Ranbaxy paid a record breaking $500 million fine after delivering false, unreliable and untrustworthy drug quality data from its qualify control laboratory. In addition, Ranbaxy has entered into a Consent Decree with the United States Food and Drug Administration. Under the terms of this Consent Ranbaxy must (at Ranbaxy’s expense):

• Establish, and appoint a third party expert(s) to, the position(s) of Data Integrity Expert(s) to identify:
  • Unreliable and untrustworthy data submitted to FDA
  • Systems, procedures and management behaviours that may have contributed to the delivery of unreliable and untrustworthy data
  • Specific management staff who were in position when the unreliable and untrustworthy data was created and delivered, and if any of those managers are still in position
• Establish an Office of Data Reliability within the United States
• Establish adequate controls and procedures to ensure the reliability and trustworthiness of all data in the company’s drug applications
• Withdraw any drug applications found or suspected to contain untrue statements

Massachusetts Forensic Drug Laboratory

The lax quality assurance at The Massachusetts Forensic Drug Laboratory led to its closure in August of 2012.