RENEE MONTAGNE, host:
And the Obama administration has announced a settlement with the nation's largest drug maker. A $2.3 billion settlement with Pfizer comes after a four-year investigation.
Pfizer was accused of illegally marketing one of its drugs, which has since been taken off the market. The settlement includes a record $1.2 billion criminal penalty.
NPR's Brian Naylor reports.
BRIAN NAYLOR: The settlement centers around the anti-inflammatory drug Bextra. It was approved by the Food and Drug Administration to treat arthritis, but Pfizer wanted to expand its market for the drug and sought the FDA's approval to make it available for other ailments.
The FDA, citing concerns over Bextra's safety, said no - but that didn't stop Pfizer, according to Assistant Attorney General Tony West.
Mr. TONY WEST (Assistant Attorney General): 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.
NAYLOR: Off-label marketing is not an uncommon practice among drug companies eager to maximize their profits. Earlier this year, Eli Lilly paid a $1.4 billion fine for illegally marketing an anti-psychotic drug. Dr. Jerry Avorn, a professor of medicine at Harvard, says in the case of Pfizer and Bextra, the practice could've been deadly.
Dr. JERRY AVORN (Professor of Medicine, Harvard University): So, besides the fact that a lot of people or governments or insurers ended up paying billions of dollars for purposes that the drug was not useful to treat, we also can expect that that additional use resulted in thousands and thousands of people have drug-induced heart attacks that they didn't need to have and may not have had if it were not for this excessive marketing of their drugs.
NAYLOR: Law enforcement officials say Pfizer wined and dined doctors in an effort to get them to prescribe the drug for unapproved uses. Michael Loucks is the acting U.S. attorney for Massachusetts.
Mr. MICHAEL LOUCKS (Acting U.S. Attorney, Massachusetts): Pfizer invited doctors to consult at meetings, many in resort locations. Attendees' expenses were paid, they received a fee just for being there, and they were entertained with golf, massages and other activities. Their job was to help Pfizer figure out how best to promote Bextra for the off-label indications.
NAYLOR: In fact, federal authorities said Pfizer is a repeat offender, having already reached settlements with the Department of Justice on three previous occasions, including twice for off-label marketing.
This time the price is steep. The company is being fined nearly $1.2 billion -the largest criminal fine ever, according to the Justice Department. Pfizer will also forfeit over $100 million in profits. And it will pay $1 billion to reimburse Medicare, Medicaid and other health care programs for falsely promoting Bextra and three other drugs.
Showing the Obama administration's intention to get tough with drug makers, Health and Human Services Secretary Kathleen Sebelius appeared at yesterday's news conference.
Secretary KATHLEEN SEBELIUS (Department of Health and Human Services): These steps reflect the Obama administration's dual focus on prosecuting and preventing health care fraud. We don't want to just catch crooks; we want to stop them before they strike.
NAYLOR: Pfizer's attorney issued a statement saying the company regrets, quote, "certain actions taken in the past but that we are proud of the action we've taken to strengthen our internal controls." The statement says corporate integrity is, quote, "an absolute priority for Pfizer."
Brian Naylor, NPR News, Washington.
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