Off-label marketing costs Pfizer

Sign for the world headquarters of Pfizer Inc. in New York City.


Kai Ryssdal: So you go to your doctor, she gives you medicine. So far so good. Within the limits of ethics and good medical practice, she can prescribe almost anything she wants to treat whatever ailment you have. Where it gets tricky is when you bring pharmaceutical manufacturers into the equation.

They can only market the drugs they make to treat the specific illnesses the FDA has approved it to treat. To do otherwise is what you call off-label marketing. And that is why Pfizer's going have to come up with $2.3 billion in civil and criminal fines. From Washington, Marketplace's Tamara Keith reports.

TAMARA KEITH: Doctors prescribe drugs off-label all the time, often with good results. But there are down sides too.

Dr. Caleb Alexander at the University of Chicago cites a study that found nearly 75-percent of off-label drug uses lack scientific support.

CALEB ALEXANDER: We're talking about tens of millions of prescriptions a year. This is not a small volume of therapies.

There's big money in selling a drug for more than one use. And in this case Pfizer marketed uses that weren't approved, says Tony West, an assistant attorney general at the Justice Department.

TONY WEST: Pfizer asked the FDA if it could promote the sale of Bextra, which is an anti-inflammatory drug, for certain other uses and in doses which were higher than the approved maximum. The FDA, citing safety concerns, said no. But Pfizer marketed Bextra for those unapproved uses anyway.

Pfizer says it regrets actions taken in the past. Doctors learn about off-label uses from colleagues, journal articles, and continuing education courses often sponsored by drug companies.

Pfizer also supplied a curriculum that illegally pushed off-label uses of its drugs.

Dr. Alexander recently conducted a survey of physicians about several common drugs.

DR. ALEXANDER: We examined physicians use of Quetiapine to treat dementia with agitation.

That's an off-label use of the anti-psychotic drug. At the time of the survey, the FDA was advising doctors to be careful about using it in dementia patients.

DR. ALEXANDER: And yet, nearly one in five of the physicians we surveyed erroneously thought that it was FDA approved.

Could that be the power of marketing?

In Washington, I'm Tamara Keith for Marketplace.

Log in to post4 Comments

The promotion of off label use of medication is and should be illegal, but off label use of medication is done all the time. For example asprin has been recommended by the American Heart Association and US Preventative Task force for the primary prevention of heart attacks in moderate risk individuals. This is not an approved indication by the FDA but this has saved 100s of thousands of lives at a very low cost
Raj Bhattacharya MD
Professor of Endocrine
U of Kansas

A little ethics training for the sales force and management will tidy this up. The fine is not a huge deal, more of an embarassment. Management is really foolish for allowing off-label marketing. HEads should roll!. The rank and file of Pfizer have suffered already, roll some of the brass!

Exactly why Pfizer, along with all the rest of big pharma, need to have their wings clipped. My wife was on Bextra for nerve pain and developed side effects. I'm certainly glad the Vioxx issue came to the surface.

Will $2.3 billion penalty change Pfizer practices? I do not think so. Probably the management at Pfizer is brain storming how to pass this penalty to consumers as increased drug prices!!

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