Off-Label Marketing

Off-label marketing has landed Pfizer with a $2.3bn (£1.4bn) criminal fine for the illegal and fraudulent promotion of four of its drugs for uses that had not been approved by the medical regulators. The biggest in the history of the US Department of Justice. This was an out-of-court settlement.

PHARMACEUTICALS

Pfizer to pay $2.3 billion fine for fraudulent marketing

Sebelius Announces Pfizer's record fine in Washington, DC © ASSOCIATED PRESS

   While the practice of off-label marketing is not unusual, the enormity of the fine is. The authorities branded Pfizer as a repeat offender, noting that this was the fourth settlement the drug maker had made in the last decade for off-label marketing.

The settlement comprises a $1.3 billion fine to settle criminal charges for misbranding the anti-inflammatory drug Bextra with intent to defraud and mislead; and a $1 billion civil fine to settle allegations that Pfizer illegally promoted Bextra, as well as the antipsychotic Geodon, the antibiotic Zyvox and the anti-epileptic Lyrica.

   Kathleen Sebelius, the secretary of Department of Health and Human Services, said the agency...

'will continue to seek opportunities to work with its government partners to prosecute fraud wherever we can find it.'

Off-label Prescription Drugs

Off-label does not demonstrate that a drug is dangerous, but just that it has not been approved for additional therapeutic applications. The original approval would have been granted for the whole gamut of clinical trials and full safety testing. The enormous cost of bringing a drug to the marketplace makes financial recovery of (some of) these costs very important.

   Pre-empting further potential approvals without such approval runs a huge financial on-cost risk. The damage to reputation is much greater. The harm done to the name of an otherwise reputable and ethical company must compromise this public appreciation of what defines being 'ethical'. Trust must outshine corporate goals as in the longer term finances must suffer.

1.	pertaining to or dealing with morals or the principles of morality; pertaining to right and wrong in conduct.

2.	being in accordance with the rules or standards for right conduct or practice, esp. the standards of a profession: It was not considered ethical for physicians to advertise.

3.	(of drugs) sold only upon medical prescription.

Notably, a subsidiary of the firm pleaded guilty to misbranding drugs...

"with the intent to defraud or mislead"

(Pharmacia and Upjohn Company)

• Valdecoxib (Bextra)
• Ziprasidone (Geodon)
• Linezolid (Zyvox)
• Pregabalin (Lyrica)