CHAPTER §7.01 Increased Government-Enforcement Activity

• Jurisdiction: United States

§7.01 Increased Government-Enforcement Activity

[1] Introduction

Government-enforcement investigators and attorneys at the federal and state levels continue to heavily scrutinize the pharmaceutical industry across a variety of areas. With increasing regularity, government enforcement has focused on sales and marketing practices, business ties with medical professionals, and controlled-substances regulation. Intensified governmental attention to health-care fraud and rising drug costs have led to an increase in the regulation of the pharmaceutical industry. In addition, the "Yates Memo" and subsequent revisions to DOJ policy have increased the government's focus on holding individuals accountable for corporate misconduct, and the public and political focus on opioid dependence and overdoses has led to heightened government scrutiny of practitioners and companies operating in the opioid space.

As the number of investigations has increased, so has the number of agencies that conduct the investigations. At the federal level, the Department of Justice ("DOJ"), the FDA, the Department of Health and Human Services, the Department of Veterans Affairs, the Federal Bureau of Investigations, Drug Enforcement Administration ("DEA"), U.S. Postal Service, U.S. Customs Service, Department of Labor, and the Federal Trade Commission ("FTC") have all engaged in investigations of the pharmaceutical industry. State attorneys general nationwide have also initiated investigations on an array of issues and, in some instances, local district attorneys have targeted the pharmaceutical industry as well.

[2] Increased Focus on Individual Accountability for Corporate Misconduct

In 2015, then-Deputy Attorney General Sally Yates released a policy memorandum entitled "Individual Accountability for Corporate Misconduct." The "Yates Memo" identified the following six principles that would govern the Department when investigating corporate misconduct:¹

• "To be eligible for any cooperation credit, corporations must provide to the Department all relevant facts about the individuals involved in corporate misconduct."
• "Both criminal and civil corporate investigations should focus on individuals from the inception of the investigation."
• "Criminal and civil attorneys handling corporate investigations should be in routine communication with one another."
• "Absent extraordinary circumstances, no corporate resolution will provide protection from criminal or civil liability for any

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