U.S. DOJ Civil Division to Investigate Possible Violations of the Food, Drug, and Cosmetic Act by Pharmaceutical Firms Manufacturing Drugs Used in Gender Transition Care

On June 11, 2025, the U.S. Department of Justice (DOJ) Civil Division issued a memorandum outlining five Trump administration policy objectives and “direct[ing] Civil Division attorneys to prioritize investigations and enforcement actions advancing these priorities.”1 The memorandum is signed by Assistant Attorney General Brett A. Shumate, who was confirmed by the Senate two days earlier, on June 9, 2025.2 One of the five policy objectives, entitled “Protecting Women and Children,” has potentially significant enforcement implications for pharmaceutical companies whose drugs may be used in gender transition care — even if they are used off-label.

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The Freeze Has Thawed: DOJ Issues New Directive to Pursue FCPA Cases that Vindicate U.S. National Interests

On June 10, 2025, the U.S. Department of Justice (DOJ)’s Deputy Attorney General, Todd Blanche, unveiled DOJ’s new “Guidelines for Investigations and Enforcement of the Foreign Corrupt Practices Act (FCPA)” (FCPA Guidelines). The FCPA Guidelines, directed to the head of the DOJ’s Criminal Division, Matthew R. Galeotti, follows President Donald Trump’s February 10, 2025 executive order (EO) generally pausing FCPA enforcement for 180 days and directing the Attorney General to develop new criteria for new FCPA investigations in that same time period. (The prior EO was analyzed in a Sidley alert available here.)

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U.S. DOJ Launches Initiative Leveraging False Claims Act to Target Diversity, Equity, and Inclusion Programs

In a May 19, 2025 memorandum, U.S. Department of Justice (DOJ) Deputy Attorney General Todd Blanche announced the Civil Rights Fraud Initiative, which aims to use the False Claims Act (FCA) to investigate and “pursue claims against any recipient of federal funds that knowingly violates federal civil rights laws” via “racist preferences, mandates, … and activities” — including diversity, equity, and inclusion (DEI) programs. (more…)

U.S. DOJ Unveils White-Collar Enforcement Priorities and Corporate Enforcement Policy Revisions

On May 12, 2025, the Head of the U.S. Department of Justice Criminal Division, Matthew Galeotti, provided the Trump administration’s first comprehensive articulation of white-collar priorities and revised corporate enforcement policies in remarks delivered at the Securities Industry and Financial Markets Association Anti-Money Laundering and Financial Crimes Conference. (more…)

U.S. DOJ Shifts Focus in Digital Asset Enforcement

The U.S. Department of Justice (DOJ or Department) has announced a significant shift in enforcement priorities concerning digital assets. On April 7, 2025, Deputy Attorney General Todd Blanche issued a memorandum (Memorandum) announcing that the Department is not a “digital assets regulator” and will no longer pursue litigation or enforcement actions that “have the effect of superimposing regulatory frameworks on digital assets.” Instead, the Memorandum directs DOJ to focus on the prosecution of conduct that victimizes investors or uses digital assets in furtherance of crimes such as terrorism, narcotics trafficking, hacking, and human trafficking.

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Ian McGinley, Former Director of Enforcement for the CFTC, Joins Sidley’s Regulatory and Enforcement Practice

Sidley is pleased to announce that Ian McGinley has joined the firm as a Securities Enforcement and Regulatory partner in the Regulatory and Enforcement practice group in New York. Mr. McGinley was most recently the Director of Enforcement for the U.S. Commodity Futures Trading Commission (CFTC). At Sidley, he will focus on regulatory enforcement and white-collar criminal defense, with a particular emphasis on commodities and securities laws. He will also advise clients in civil and criminal matters involving digital assets.

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DOJ Enforcement Outlook in Health Care Compliance for 2025

Some predicted a drop in False Claims Act (”FCA”) enforcement during the first Trump administration, but setting aside a likely pandemic-related slowdown during 2020–2022, FCA cases — both DOJ-initiated and qui tam — during the early part of the first Trump administration were consistent with the volume in the later part of the Biden administration.

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Federal Judge Pauses Enforcement of DEI Executive Order; FCA Risks Remain

On Friday, February 21, a federal district judge in Maryland issued a nationwide preliminary injunction prohibiting the U.S. Department of Justice (DOJ) and defendant federal agencies from enforcing portions of two presidential executive orders (EOs) targeting diversity, equity, and inclusion (DEI) programs at companies that do business with the federal government, including provisions tethering allegedly unlawful DEI programs to potential False Claims Act (FCA) liability.

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