---
title: "Justice Department directive expands fraud enforcement to include pharmaceutical firms"
id: "stat-news-4-stat-justice-department-targets-drugmakers-in-new-directive-on-combating-white"
canonical_url: "https://medichelpline.com/clinical-feed/stat-news-4-stat-justice-department-targets-drugmakers-in-new-directive-on-combating-white"
content_type: "clinical_feed_article"
specialty: "Pharmacology"
source_name: "STAT News"
source_url: "https://www.statnews.com/pharmalot/2026/10/07/trump-administration-adds-pharma-to-list-priorities-combating-white-collar-fraud/?utm_campaign=rss"
published_at: "2026-10-07T12:10:42.000Z"
evidence_level: "Verified Feed"
license: "CC-BY-NC-4.0 / Informational Use"
---
# Justice Department directive expands fraud enforcement to include pharmaceutical firms
## Provenance & Clinical Metadata
- **Canonical URL:** https://medichelpline.com/clinical-feed/stat-news-4-stat-justice-department-targets-drugmakers-in-new-directive-on-combating-white
- **Specialty:** [Pharmacology](https://medichelpline.com/clinical-feed/pharmacology.md)
- **Primary Source:** STAT News
- **Source URL:** [Original Journal Publication](https://www.statnews.com/pharmalot/2026/10/07/trump-administration-adds-pharma-to-list-priorities-combating-white-collar-fraud/?utm_campaign=rss)
- **Published At:** 2026-10-07T12:10:42.000Z
- **Evidence Rating:** Verified Feed
## Executive GIST (TL;DR)
- The U.S. Department of Justice (DOJ) issued a new directive aimed at combating white-collar fraud that explicitly references enforcement under the **Federal Food, Drug, and Cosmetic Act**. - The directive was issued by the DOJ’s National Fraud Enforcement Division and signals that drug and device manufacturers may now be more directly targeted alongside traditional health fraud defendants such as providers, clinics, home health agencies, and hospices. - A former DOJ official, Kevin Lowell, described the move as a “subtle but significant expansion” of the fraud division’s jurisdiction; he previously served as a deputy chief in the division’s health care fraud section. - The article reporting the directive comes from STAT News Pharmalot (Ed Silverman) and notes the DOJ document but the story is behind STAT+ paywall; full details of the directive, including specific enforcement priorities, examples, or operational changes, were not reported in the available source excerpt. - The source material confirms the directive’s inclusion of the Federal Food, Drug, and Cosmetic Act but does not provide the directive’s date, the full text, case examples, implementation timeline, or responses from industry or DOJ representatives. - Because the published article is partly behind a subscription wall, additional facts about how the directive will be operationalized, which DOJ units will lead investigations of drugmakers, or whether new resources or priorities were allocated are not available from the source. - The public notice of the directive and commentary in the article indicate a potential shift in enforcement focus that companies in the life sciences and medical device sectors should monitor; specific compliance guidance or recommended steps were not provided in the source.
## Clinical Analysis & Structured Key Points
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[](https://www.linkedin.com/in/edsilverman/ "Linkedin") 2. [](https://x.com/Pharmalot "X") ed.silverman@statnews.com Ed’s stories explore prescription drug pricing, affordability and access, as well issues surrounding patents, litigation, and legislation. He is also the author of the morning [Pharmalittle newsletter](https://www.statnews.com/signup/pharmalittle/) and the afternoon [Pharmalot newsletter](https://www.statnews.com/signup/pharmalot/). In a warning to life sciences companies, the U.S. Department of Justice last week issued a new directive for combating fraud that made a point of noting the agency will pursue violations of a federal law that tightly regulates the pharmaceutical industry. Typically, the agency has pursued health fraud cases centered on providers, clinics, home health agencies, and hospices. By expressly including the Federal Food, Drug, and Cosmetic Act in [the directive](https://www.justice.gov/opa/media/1463571/dl?inline), the National Fraud Enforcement Division appears to be placing drug and device makers, among others, more clearly in its crosshairs. Advertisement “This is a subtle but significant expansion of their jurisdiction,” said Kevin Lowell, a member of the Miller & Chevalier law firm, who spent a decade at the DOJ, where he most recently had been a deputy chief in the National Fraud Enforcement Division’s health care fraud section. STAT+ Exclusive Story Already have an account? 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