The world’s biggest drug maker has been fined a record amount by US regulators for fraudulent marketing. Pfizer was fined a total of $US2.3bn (£1.4bn), the largest healthcare fraud settlement in US history, for trying to sell drugs for uses not approved by the regulators. The US Government says the practices put public health at risk. Pfizer paid the fines to settle criminal and civil allegations that it illegally sold four drugs for uses not approved by the Food and Drug Administration (FDA).
One of those products was Bextra, an arthritis drug which Pfizer told doctors could ease severe pain. The company marketed the product as a painkiller even though the FDA refused approval for wider use because of safety concerns.
Pfizer was fined $US1.3 bn for falsely marketing Bextra, the largest criminal fine ever imposed in the US. Pfizer’s subsidiary, Pharmacia & Upjohn Company, pleaded guilty to a felony violation for mis-branding Bextra with the intent to defraud or mislead. Bextra was withdrawn in 2005 after concerns it could cause heart attacks and strokes.
Pfizer was also accused by authorities of paying kickbacks to doctors to prescribe its drugs.
The US Health Secretary, Kathleen Sebelius, said: “This is the first time ever that a drug company has agreed to look at the risks associated with marketing on its own and develop a plan to deal with those risks.”
Regulators are getting tougher both in the US and on this side of the channel. Pharma is the most strictly regulated of all industries so it’s no surprise to see the government showing its teeth; the surprise is that the internal processes of the world’s largest drugs manufacturer failed to prevent it from happening. With pharma marketing moving to the web, and brands having increasingly integrated marketing strategies (whether selling to consumers or to medical practitioners), regulators are going to become increasingly demanding that standards and codes are being followed.
Pfizer has been found guilt of a structured marketing campaign to mislead prescribers and boost sales on a grand scale. More is yet to come, because on a small scale, the individual emails from thousands of pharma sales reps may tell much bigger stories. Conversations that were once private behind closed surgery doors are now recorded in the proxy servers and email folders of both parties. At some point the regulators will dig deep into those archives and not like what they find.