DOJ’s New Fraud Enforcement Priorities: What Life Sciences Companies Need to Know

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Did You Know?

On October 1, 2026, DOJ’s National Fraud Enforcement Division issued Directive 26-12, promising an “aggressive, all-tools approach” to health care, government, tax, and trade fraud. The directive instructs Fraud Division prosecutors to work directly with the Division’s new Corporate Enforcement Section at all phases of corporate investigations, from intake through resolution.

What Are DOJ’s Priorities?

Fraud Division prosecutors are directed to prioritize fraud schemes involving:

  1. Health care, including controlled substances, and FDCA violations
  2. Procurement, government contracts, and other government functions
  3. Significant evasion of internal or external revenue
  4. Tariff evasion, importation of goods or services, or forced labor

Why It Matters

Prosecutors must place “great weight” on factors such as:

  • Management knowledge of or involvement in the fraud
  • Concealment from agencies or auditors
  • Conduct lasting three years or more
  • Harm to 25 or more victims or $25 million or more in loss

DOJ is also building new programs to reward whistleblowers, including people who took part in the misconduct.

Preparing for Heightened Enforcement

PorzioCS can help companies assess fraud risk, strengthen compliance programs and internal reporting channels, and evaluate options for next steps under DOJ’s Corporate Enforcement and Voluntary Self-Disclosure Policy.

Is Your Compliance Program Ready?

With a dedicated Corporate Enforcement Section and whistleblower incentives on the way, now is the time for companies to evaluate risk and update their compliance infrastructure accordingly.

Contact PorzioCS to learn how we can help your company review its compliance program and prepare for heightened DOJ fraud enforcement.

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