Lilly’s Zyprexa Off-Label Settlement: Record Fine, Routine Compliance Deal
Lilly agreed to pay $1.4 billion in criminal and civil fines and pled guilty to misbranding its antipsychotic drug Zyprexa in a settlement with the U.S. Department of Justice. Despite the record-breaking sum, however, the terms in the accompanying corporate integrity agreement are similar to previous CIAs
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During the first step of the confirmation process, HHS Secretary nominee Alex Azar did a good job of framing his industry background as useful experience for tackling drug prices. But wouldn’t it be nice if everyone agreed that 10 years as Lilly was something to be proud of?
Plans are acquiring the tools to monitor and assess the risk/benefit of drug use outside of the approved indication. Smart companies are working with payers to understand their concerns around off-label use and the data requirements in support of it.
Health Care Fraud Investigations Bedevil Pharma Industry: If You're Not Under Investigation, It's Only Because You've Recently Settled
Two months ago, the Department of Justice held a splashy news conference to announce its record-breaking $2.3 billion settlement with Pfizer. The event, which included HHS Secretary Kathleen Sebelius, cast a spotlight on Pfizer's alleged off-label marketing and kickbacks to health care providers (1"The Pink Sheet," Sept. 7, 2009)