Eli Lilly agreed to pay $1.4 Billion to the U.S. government to settle criminal and civil cases surrounding the promotion of Zyprexa for the off-label promotion of its use on elderly patients with dementia.
They also entered into a five-year corporate integrity agreement (the Agreement). The Agreement applies to Eli Lilly and its employees, but also all contractors, subcontractors, agents, and other persons who perform promotional and product services related functions on behalf of Lilly.
The Agreement codifies Lilly’s current code of conduct, and the Agreement includes the review of call plans, sample distribution, and other promotional activity.
For education, the Policies and Procedures require that:
· Lilly discloses its financial support of the Third-Party Educational Activity and, to the extent feasible, be consistent with Subsection 5 below, any financial relationships with faculty, speakers, or organizers at such Activity;
· As a condition of funding, the third-party shall agree to disclose Lilly's financial support of the Third-Party Educational Activity and any financial relationships that Lilly might have with faculty, speakers, or organizers at such Activity;
· Any faculty, speakers, or organizers at the Third-Party Educational Activity disclose any financial relationship with Lilly;
· The Activity has an educational focus;
· The content, organization, and operation be independent of Lilly’s control;
· Lilly supports only Third-Party Educational Activity that is nonpromotional in tone/nature; and
· Lilly supports a Third-Party Educational Activity shall be contingent on the provider's commitment to provide information at the Educational Activity that is fair, balanced, accurate, and not misleading.
The Agreement also covers quarterly reporting of payments to healthcare providers in $10,000 increments from January 1, 2009 going forward in a searchable web database
It is disappointing that Lilly was guilty of off-label promotion and the settlement. The charges settled in this agreement are an example of the excesses of the late 1990’s and early 2000’s that happened in our industry.
There have been significant changes at companies in the last five years, and hopefully once these cases (1995- 2004) are settled, we can get back to developing therapies to help patients and spend less time fighting legal battles.
Resources:
Eli Lilly Press Release: Lilly resolves investigations of past Zyprexa marketing and promotional practices
US Attorney Eastern District of Pennsylvania
Pharmaceutical Company Eli Lilly to Pay Record $1.415 Billion for Off-label Drug Marketing
Government's Memorandum For Entry Of Plea and Sentencing
Press
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Bloomberg: Lilly to pay $1.42 billion to resolve Zyprexa probes |
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LA Times: Lilly to pay total of $1.42 billion to settle Zyprexa suits, pleads guilty to marketing charge – |
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Indianapolis Star Ledger: Lilly settles over Zyprexa for $1.4B |
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Wall Street Journal Lilly reaches Zyprexa settlement |