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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