Are fines enough to deter off-label marketing?

In the wake of last week's $2.3 billion settlement between Pfizer and the U.S. government, experts are looking at that enormous price tag--and finding not much of a deterrent, the Associated Press reports. Even though the deal included a felony plea by the Pfizer subsidiary Pharmacia & Upjohn, and even though the fines reached record levels, that's not enough to stop off-label marketing.

The FDA allows drugmakers to promote their products only for uses that the agency has expressly approved. But doctors are free to prescribe drugs for other uses as they see fit. In recent years, several drugmakers have paid hundreds of millions--even more than a billion--to settle claims that they flouted those rules and pushed drugs for off-label uses. But those big settlements still didn't equal the multibillion-dollar sales figures for those drugs.

Take Eli Lilly's agreement to pay $1.42 billion over alleged mismarketing of its antipsychotic drug Zyprexa. The popular medication brought in $4.69 billion in 2008 and $4.76 billion in 2007. Or Cephalon's $425 million settlement on its Actiq, Provigil and Gabatril promotions. Provigil alone brought in $801 million in 2007 and $925 million in 2008, the year the settlement was signed.

In Pfizer's case, Bextra--which accounted for the lion's share of the $2.3 billion settlement--brought in $687 million in 2003 and $1.286 billion in 2004, the last two full years of sales before it was pulled from the U.S. market. Lyrica, which also was covered in the marketing settlement, accounted for $2.6 billion in 2008 sales, the AP reports. And even though Pfizer took the entire $2.3 billion settlement as an earnings charge for the fourth quarter of 2008, Pfizer still managed to post a profit for the quarter of $268 million.

- read the AP story

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