American Journal of Law & Medicine

Recent developments in the law of off-label promotion of prescription drugs: litigation and federal guidelines.

Recent developments in the law of Off-Label Promotion of Prescription Drugs: Litigation and Federal Guidelines. The health care industry has recently reported a number of record breaking settlements resulting from criminal prosecutions for off-label marketing. (1) These settlements came at the same time the U.S. Food and Drug Administration (FDA) revised its guidelines regarding off-label marketing, expanding an exemption for certain types of informational material. (2) While the settlements are undeniably substantial, it is still unclear how the industry will respond to them, and whether the FDA's newly adopted rules will affect that response.

In January of 2009, Eli Lilly and Pfizer, two of the largest pharmaceutical companies in the country, settled criminal complaints against them for $1.4 billion and $2.4 billion respectively. (3) Eli Lilly was accused of marketing its Schizophrenia drug Zyprexia for uses that had not been approved by the FDA, including the treatment of eating disorders and dementia in the elderly. (4) The company admitted to actively training its marketing representatives to discuss off-label uses with primary care physicians, going as far as to support a "5 at 5" slogan to help doctors remember the recommended dosage in milligrams and the recommended time for treatment. (5) While it was not immediately clear which off-label uses or what specific activities were implicated in Pfizer's federal settlement involving the arthritis drug Bextra, Pfizer recently settled a similar complaint with Kentucky alleging that Bextra was marketed for acute and surgical pain. (6)

At the time of entry, each settlement represented the largest off-label marketing payout in history. (7) These claims have followed a number of other big ticket settlements in recent years, including settlements from Cephalon, Inc. in September 2008 for $425 Million, (8) Purdue Pharma in May 2007 for $19.5 million, (9) and Swiss drug maker Serono in 2005 for $704 million. …

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