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 | 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.
