The U.S. Department of Justice (DOJ) and other government enforcers announced a number of key settlements in the life sciences industry in July – September 2019. These settlements include:
LIFE SCIENCES INDIVIDUALS/ ENTITIES |
SETTLEMENT DATE |
RESOLUTION |
KEY AREAS OF ENFORCEMENT |
Pharmaceutical company |
Sept. 26, 2019 |
$108M
Deferred prosecution agreement
Forfeiture
|
· Criminal liability
· False Claims Act
· Kickbacks
· Misbranding
· Speaker programs
|
Former CEO of compounding pharmacy |
Sept. 19, 2019 |
$25,000
33 months in prison
|
· Consumer protection
· Conspiracy to defraud FDA
· Distributing adulterated drugs
|
Compounding pharmacy
CEO
Former VP of Operations
Private Equity Firm
|
Sept. 18, 2019 |
$21.36M |
· False Claims Act
· Kickbacks
· Telemedicine
· Copayment assistance
|
Pharmaceutical company |
Sept. 4, 2019 |
$15.4M |
· False Claims Act
· Kickbacks
· HCP dinners and entertainment
|
Pharmaceutical company |
July 11, 2019 |
$1.4B
Non-prosecution agreement
Forfeiture
|
· Criminal liability
· False Claims Act
· Federal Trade Commission Act
· Medical necessity
· Diversion
· False FDA submission
|
These settlements demonstrate the continued importance for life sciences companies to monitor industry developments and determine ways in which to improve their corporate compliance programs.
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