Pfizer will pay a record $2.3bn in final settlement of a US Justice Department probe into accusations of off-label marketing of 13 drugs, including painkiller Bextra. The COX-2 inhibitor was taken off the market in 2005, when it was linked to side effects including cardiovascular events and Stevens Johnson syndrome – a serious allergic skin reaction.
The company also agreed to plead guilty to the charge of "misbranding Bextra with the intent to defraud or mislead".
Pfizer will pay a criminal fine of just over $1bn, which the Department of Justice (DOJ) says is the largest ever imposed in the US. The company will pay a further $1bn to resolve civil allegations that the company illegally marketed Bextra, the schizophrenia treatment Geodon, antibiotic Zyvox, over which it has acknowledged "certain improper actions", and anti-epileptic drug Lyrica.
In addition, the company has agreed to an "expansive corporate integrity agreement" with the Department of Health and Human Services to establish procedures and reviews to prevent similar events occurring in the future, said the DOJ.
The action is the culmination of long-running investigations into Pfizer's aggressive marketing practices. One example of this was the company's push to persuade doctors to prescribe Bextra for uses that it had not been authorised for by the US Food and Drug Administration.
"We regret certain actions taken in the past, but are proud of the action we've taken to strengthen our internal controls and pioneer new procedures so that we not only comply with state and federal laws, but also meet the high standards that patients, physicians and the public expect," Pfizer's general counsel, Amy W Schulman said in a statement.
The company said it was already committed to capping and disclosing financial payments to doctors, medical organisations and patient advocacy groups. It had also appointed a chief compliance officer and brought in training, compliance committees and a hotline to improve standards.