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.

Posted by Sarah K. diFrancesca