Who Paid The Largest Criminal Fine And Why

In 2002, the pharmaceutical giant, Pfizer, paid a record-breaking $430 million to settle federal criminal and civil charges related to the company’s marketing and promotion of the antipsychotic drug, gabapentin. This settlement was the largest criminal fine imposed on a drug company at the time, and it marked a groundbreaking shift in the DOJ’s approach to corporate wrongdoing.

At the heart of the matter was the fact that Pfizer marketed gabapentin for off-label uses that were not approved by the Food and Drug Administration (FDA). Off-label means prescribing, using, or marketing a drug for something other than what the FDA has approved it for. This is legally prohibited in the U.S., and it can be dangerous when drugs are used for something other than what they were intended for.

Pfizer actively promoted gabapentin for conditions it was not approved to treat, like bipolar disorder, obsessive-compulsive disorder, and dementia. Additionally, they used a variety of unorthodox tactics to push the drug to doctors, including providing incentives and bonuses to physicians who prescribed high numbers of gabapentin prescriptions.

Under the settlement agreement, Pfizer admitted it had violated federal criminal laws, but did not give up its legal right to press a defense if it were to be found guilty of a crime. Furthermore, the company agreed to keep closer watch on the marketing and promotion of its drugs and ensure adequate oversight over those activities going forward.

Though the company set a precedent with its record-breaking fine, the Pfizer case was by no means an isolated incident. Since 2002, there have been numerous similar cases of pharmaceutical companies being charged for violating laws regarding marketing of their drugs and promoting off-label uses.