Economic Analysis In Off-Label Promotion Cases

Law360, New York (January 26, 2009, 12:00 AM EST) -- In an increasing number of government investigations, the central allegation is that a pharmaceutical manufacturer promoted one of its products off-label. Many of these investigations have resulted in hundreds of millions of dollars in payouts by drug companies.

The sheer number of these investigations and magnitude of settlements, as well as the complex regulatory, scientific and business environment in which prescription drug sales occur, suggest a key role for economic analysis.

Newly announced U.S. Food and Drug Administration regulations that permit pharmaceutical companies to distribute copies...
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