July 30, 2013
Drug Manufacturers Fined after Neglecting Manufacturing Quality Control
On a global scale, the market for prescription drugs is expected to grow to $1.2 trillion by 2016. Drug manufacturers understandably want to do all they can to take the biggest bite they can chew out of that proverbial pie. But when it comes to the health of human beings, companies are better suited to err on the side of caution when it comes to drug production as evidenced by two recent fines filed by the Department of Justice.
Under the False Claims Act, GlaxoSmithKline (GSK) was recently ordered to forfeit $750 million, while Ranbaxy Laboratories was forced to cough up $500 million in settlements after whistleblowers exposed wrongdoing by the two drug manufacturers. According to reports, drugs produced at a GSK plant in Puerto Rico were contaminated with microorganisms, while even other drugs were produced with defects that eliminate their medicinal powers. Over at Ranbaxy, drugs used to treat epilepsy were sold despite having “unknown impurities” and unreliable shelf lives, while production of the cholesterol-lowering drug Lipitor was halted because glass got into the medicine.
By implementing thorough manufacturing quality control and monitoring the entire production process, the two drug manufacturers could have likely prevented the massive fines levied against them while at the same time keeping their brand names away from the negative publicity and fallout. No company, not even a highly profitable big pharma company, wants to lose hundreds of millions of dollars.
Even if a company is happy with the production methods it utilizes, it’s important to systematically review those methods to make sure that quality has not been compromised. In the case of these drug manufacturers, abiding by stricter manufacturing quality control standards could have prevented their tragic missteps from happening.
To learn more about manufacturing quality control and how it’s important across all industries, visit the InfinityQS blog by clicking here.