Pfizer hit with $2.3 billion in fines for criminal behavior
| This FDA smackdown is a long time in coming.
The US government has imposed a $2.3 billion fine on Pfizer for a string of offenses including illegal off-label prescribing and bribery of officials.
The fine represents the country's biggest ever fraud settlement against a pharmaceutical company, and covers criminal and civil charges.
The US Department of Justice announced the deal which would resolve criminal and civil liability linked to Pfizer's illegal off-label marketing of its painkiller Bextra for several uses and doses that the FDA had specifically declined to approve due to safety concerns.
Launched in 2002, Bextra was withdrawn just three years later in April 2005, after the FDA concluded its risks outweighed its benefits.
Pfizer pleaded guilty to the charges, and will pay a fine of $1.195 billion, the largest criminal fine ever imposed in the US for any matter. The company's subsidiary Pharmacia & Upjohn will also forfeit $105 million, for a total criminal resolution of $1.3 billion.
Pfizer has also agreed to pay $1 billion to resolve allegations under the civil False Claims Act that the company illegally promoted four drugs - Bextra; Geodon, an anti-psychotic drug; antibiotic Zyvox, an antibiotic and epilepsy treatment Lyrica.
The deal also settles allegations that Pfizer caused false claims to be submitted to government health care programmes for unlicensed indications, and which were therefore not covered by those insurance schemes.
The civil settlement also resolves allegations that Pfizer paid bribes to health care professionals to induce them to prescribe these and other drugs. The civil settlement will be divided between the federal government, to receive over $668.5 million, and the state Medicaid system, which receives $331.4 million.
Pfizer also has agreed to take part in a large scale 'corporate integrity agreement' with the Office of Inspector General of the Department of Health and Human Services. This means procedures and reviews will be put in place to avoid and promptly detect similar transgressions taking place.
The US authorities were alerted to the wrongdoing by whistleblowers. As part of the deal, six whistleblowers will receive payments worth more than $102 million, taken from the government's share of the settlement.
Word.
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