Pfizer got itself in trouble for the way it was marketing some of its drugs. Enough trouble that they need to cough up a $2.3 billion fine to the Department of Justice. (Yes, that is billion.) Under its settlement with the DOJ, Pfizer will pay a $1.3 billion criminal fine related to the company’s illegal promotion of its now-withdrawn painkiller, Bextra, and $1 billion civil fine related to other medicines. It’s the largest health-care fraud settlement in the DOJ’s history.
But that’s not all.
As part of the settlement, Pfizer entered into a Corporate Integrity Agreement with the Office of Inspector General of the U.S. Department of Health and Human Services. The Corporate Integrity Agreement establishes some new internal structures and requires Pfizer to continue maintenance of a corporate compliance program for a period of five years.
Pfizer already had a compliance program, headed by a chief compliance officer, which trains employees on how to properly promote Pfizer’s products. The big change is that the chief compliance officer will no longer report to the general counsel, but will report directly to the CEO. The change is intended to eliminate conflicts of interest and prevent Pfizer’s in-house lawyers from reviewing or editing reports required by the Corporate Integrity Agreement.
If you wonder whether the compliance program should report to the general counsel, the Department of Justice says they should not.
References:
- Corporate Integrity Agreement hosted on JD Supra
- $2.3bn Pfizer settlement strips legal team of compliance brief from Legal Week
- Going With Plan B: Pfizer GC No Longer Oversees Compliance by Amy Miller for Corporate Counsel
- In Recovery: Pfizer Does Damage Control After $2.3B Settlement by Amy Miller for Corporate Counsel
- Pfizer Concludes Previously Disclosed Settlement Agreement With U.S. Department Of Justice Regarding Past Promotional Practices – Pfizer press release