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Pfizer Settles Unlawful Marketing Case for $2.3 Billion

Pfizer Inc., the world's largest drugmaker, agreed to plead guilty under a $2.3 billion federal settlement over unlawful marketing of the anti-inflammatory drug Bextra. Ray Suarez reports on the record fine.

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  • JIM LEHRER:

    The world's largest drugmaker agreed to pay a record $2.3 billion in civil and criminal penalties. After a four-year investigation, the government said Pfizer illegally promoted four prescription drugs, including the painkiller Bextra.

    Assistant Attorney Gen. Tony West spoke at a news conference this morning.

  • TONY WEST:

    Once a drug is approved for an intended use, it may not be marketed or promoted for so-called off-label uses, that is, a use that is not specified in the application and approved by the FDA.

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

    When off-label marketing like this occurs, patients' health and lives are put at risk, and those who cause that risk must be held accountable.

  • JIM LEHRER:

    Ray Suarez takes the story from there.

  • RAY SUAREZ:

    Here to tell us more about the case and the record fine Pfizer agreed to is Scott Hensley, the health correspondent for National Public Radio's Health Blog.

    And, Scott, let's start with some more details on what the government said Pfizer did and what the company ultimately pled guilty to.

  • SCOTT HENSLEY:

    Sure.

    Pfizer, as the intro said, was taking drugs that had approved by the FDA for one thing and trying to induce doctors, according to the government, to use them for other things. A physician is free to prescribe a medicine for any use that he or she sees fit. And the problem was that Pfizer was trying to get doctors to do this in a systematic way.

  • RAY SUAREZ:

    Now, for instance, let's take Bextra, the now-withdrawn pain drug.

  • SCOTT HENSLEY:

    Right.

  • RAY SUAREZ:

    If you saw commercials on television — and many drugs are widely advertised on TV now — companies wouldn't suggest off-label uses on TV or radio or in print ads.

  • SCOTT HENSLEY:

    Right.

  • RAY SUAREZ:

    How did they go about marketing it…

  • SCOTT HENSLEY:

    Right.

  • RAY SUAREZ:

    … toward off-label use?

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