Outsourced Drug Safety Monitoring Feeds a Growing $2 Billion Industry

A Wall Street Journal investigation has uncovered an industry-wide practice of pharmaceutical companies outsourcing drug safety monitoring, which may potentially affect the level of safety oversight in the market. Drug giants like AstraZeneca, Bristol-Myers Squibb, and Novartis have started farming out these functions, such as analysis of side effect reports, to companies located in India.  According to the article, “Adverse reactions to medication are the fourth leading cause of death in the U.S., killing more than 100,000 people a year. Even drugs that have been on the market for decades can have unknown and deadly side effects.”  The article goes on to say that, “Critics of the practice say drug monitoring is difficult, requiring deep experience and a knack for detective work in addition to knowledge of biochemistry and pharmacology, and that the shift toward outsourcing carries risks that deadly side effects will go unnoticed.”  Still, the outsourcing of this critical function is expected to grow by 100% in the next 5 years—potentially putting future drug safety at a much greater risk.


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