Pfizer agrees to plead guilty in painkiller case

Pfizer, the world’s largest pharmaceutical group, on Wednesday agreed to plead guilty to illegally promoting its painkiller Bextra, as part of a record-breaking $2.3bn final settlement reached with federal and state authorities across the US.

The company signed a “corporate integrity agreement” with the Department of Health and Human Services requiring regular and independently audited re­ports over five years de­signed to ensure im­proved marketing practices.

It also acknowledged “certain improper actions” in promoting its antibiotic Zy­vox and agreed to pay $33m to end compensation claims on its schizophrenia treatment Geodon, in addition to $2.3bn in fines on 13 drugs agreed in principle at the start of this year.

The action follows long-running investigations into aggressive marketing by Pfizer on medicines, which included efforts to encourage doctors to prescribe Bextra – a drug withdrawn in 2005 – for uses that the US Food & Drug Administration had specifically refused to authorise.

It comes at a time when the practices adopted by pharmaceutical companies to sell their drugs have been increasingly criticised by regulators, doctors and healthcare providers for potentially jeopardising patient safety and imposing excessive costs.

“This historic settlement will return nearly $1bn to Medicare, Medicaid and other government insurance programmes . . . [My] department will continue to seek opportunities to work with its government partners to prosecute fraud wherever we can find it  . . . Healthcare is too important to let a single dollar go to waste,” said Kathleen Sebelius, secretary of the Department of Health and Human Services.

Amy Schulman, general counsel of Pfizer, said: “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 said it was already committed to capping and disclosing financial payments to doctors, medical organisations and patient advocacy groups, and has appointed a chief compliance officer as well as introducing training, compliance committees and a hotline to improve standards.

Its $2.3bn settlement with the Department of Justice includes a $1.3bn criminal penalty on Bextra and $1bn in civil payments, some to be distributed to 49 states and the District of Columbia, which brought actions related to its practices with other drugs including Zyvox, Geodon and the epilepsy treatment Lyrica.

The group said it denied civil allegations brought by states in relation to marketing these medicines except for Zyvox, while pleading guilty to one criminal count of violating the Food, Drug and Cosmetic Act in relation to promotion of Bextra.