Eli Lilly Slapped for Off-Label Drug Use
January 07, 2006
Drug maker Eli Lilly and Co. has agreed to pay a $36-million settlement after pleading guilty to a federal misdemeanor charge that it promoted off-label use of its osteoporosis drug Evista.
A Department of Justice investigation found that, in 1998, Lilly sales representatives promoted Evista as a useful drug for preventing and reducing the risk of breast cancer and reducing the risk of heart disease. However, neither use has been approved by the Food and Drug Administration.
Though doctors may prescribe drugs for off-label uses, drug makers may not market them for unapproved uses.
A $6-Million Criminal Fine
A federal judge must approve the plea agreement, which includes a:
- $6-million criminal fine
- $6-million forfeiture to the government
- Payment of $24 million to settle civil action
In addition, the settlement includes a permanent injunction and a consent decree in which Lilly promises not to use marketing and promotion practices that violate the Food, Drug, and Cosmetic Act.
Off-Label Use Promoted to "Expand Sales"
The Department of Justice reported that Lilly promoted Evista for the two off-label uses "to expand sales of the drug."
Lilly had forecasted sales of $401 million for Evista, however, first-year Evista sales amounted to only $120 million.