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Observations The Washington Brief

Escalating criminal and civil violations: pharma has corporate integrity? Not really

BMJ 2013; 347 doi: (Published 18 December 2013) Cite this as: BMJ 2013;347:f7507
  1. Sidney M Wolfe, founder and senior adviser
  1. 1Health Research Group at Public Citizen, Washington, DC
  1. Swolfe{at}

Sidney M Wolfe looks at the system that should, but does not, deter drug companies from breaking the law

Are criminal and civil penalties of hundreds of millions of dollars an important deterrent to law breaking by international drug companies?

Further, would external monitoring in the form of US government mandated corporate integrity agreements (CIA)1 to prevent recurrences of such illegal activities, lasting five years after being signed, be an additional deterrent? Yes in both cases, but only if the size of the penalties outweighed the companies’ gains while violating the laws and only if enforcement of the CIAs were effective. Unfortunately, neither is the case. This evaluation is based on the recent, sharp escalation in the frequency with which many giant multinational drug companies repeatedly engage in illegal criminal and civil activity after previously paying enormous fines and despite monitoring under CIAs. It seems that for some companies, commission of such criminal and civil violations has become part of their business models.

In 2012, we updated previous data to include all civil and criminal penalties paid to the US federal and state governments by pharmaceutical companies from January 1991 through 18 July 2012. The overall findings included: $30.2bn (£18.5bn; €22bn) in criminal and civil penalties was paid by drug companies to federal and state governments during this time period.

More than half of the total amounts of penalties were either for illegal promotion or illegally overcharging government programs for drugs. In the past three and a half years alone …

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