FDA Enforcement Year in Review

The year 2025 marked a period of significant transformation in FDA and Department of Justice (DoJ) enforcement activities. While traditional priorities around product quality, safety, and clinical research integrity remained central, the enforcement landscape increasingly reflected the current administration’s policy objectives, workforce restructuring, and evolving legal frameworks. A Ropes & Gray review by three of its attorneys examines the key developments that are likely to shape compliance strategies heading into 2026.

The Make America Healthy Again (MAHA) movement has substantially influenced enforcement priorities, the attorneys write. HHS Secretary Robert F. Kennedy Jr. characterized recent actions as promoting “radical transparency” regarding drug safety risks and breaking “the cycle of overmedicalization that drives America's chronic disease epidemic.”

The review says the shift was most visible in 9/2025, when HHS and FDA announced aggressive enforcement plans targeting direct-to-consumer drug advertising. The agencies subsequently issued over 125 Warning and Untitled Letters to manufacturers, compounding pharmacies, and telehealth companies for allegedly false or misleading promotional claims.

A noteworthy development emerged with Executive Order 14187 and Attorney General Pam Bondi’s 4/2025 memorandum outlining plans to use the Federal Food, Drug, and Cosmetics Act (FFDCA) and the False Claims Act to investigate providers and pharmaceutical companies involved in gender-affirming care for minors. The memorandum asserted that promoting off-label hormone use may violate FDA prohibitions on misbranding, despite court precedents recognizing First Amendment protections for truthful commercial speech.

By 7/2025, the department had issued over 20 subpoenas to healthcare facilities and disclosed additional subpoenas to major drug manufacturers. Several subpoenas have been challenged and partially quashed by federal courts, with ongoing litigation continuing to shape the boundaries of permissible scientific exchange and intended use determinations.

Perhaps the most consequential development for long-term enforcement patterns, the attorneys write, was the dissolution of the DoJ’s Consumer Protection Branch in 2025. This specialized unit had historically supervised civil and criminal FFDCA matters to ensure uniform application and maintained exclusive authority to defend FDA actions under the Administrative Procedure Act.

The defunct branch’s functions have been redistributed to the Civil Division’s new Enforcement & Affirmative Litigation Branch and a Health & Safety Unit within the Criminal Division’s Fraud Section. The attorneys say the loss of this centralized hub raises concerns about:consistency in enforcement theory selection and application;

• coordination between the DoJ and FDA’s Office of Chief Counsel;
• institutional knowledge preservation following significant personnel departures; and
• individual U.S. Attorneys’ Offices potentially pursuing FFDCA matters with less specialized expertise.

Executive Order 14294, issued in 5/2025, directed federal agencies to curb criminal prosecutions of strict liability regulatory offenses. The order characterized such enforcement as “generally disfavored” and emphasized:criminal prosecution as a last resort;

• greater reliance on civil and administrative enforcement;
• clear mens rea (the criminal intent or mental state a person must have while committing a crime for them to be held legally responsible) standards for criminal prosecution; and
• agency inventory of criminal regulatory offenses within one year.

If implemented as written, the attorneys say, EO 14294 could significantly reduce FFDCA misdemeanor prosecutions, which have historically formed the basis for major criminal resolutions. Companies may see increased reliance on FDA civil enforcement tools (injunctions, seizures) and False Claims Act theories as alternatives to criminal prosecution.

The review includes a description of key enforcement activities in FDA by regulated industry sector.

The attorneys conclude with these key takeaways:

• continued policy-driven enforcement – direct-to-consumer advertising scrutiny and gender-affirming care investigations will likely remain priorities, with potential expansion based on judicial outcomes;
• quality and safety remain non-negotiable – despite organizational changes, product quality violations continue attracting significant enforcement, meaning companies should maintain robust quality systems and compliance programs;
• monitor evolving enforcement theories –loss of the Consumer Protection Bureau centralization may lead to less consistent FFDCA theory application;
• prepare for non-FFDCA alternatives –increased False Claims Act, wire fraud, and other statute usage may bring higher sentences and different procedural challenges;
• executive accountability persists –individual prosecutions demonstrate continued personal liability risks for quality and regulatory decisions; and
• anticipate resource constraints –workforce reductions at FDA and DoJ may affect inspection frequency, investigation timelines, and matter selection.

The 2025 enforcement landscape reflected both continuity and change, the attorneys say. Traditional priorities around product quality, clinical research integrity, and patient safety remained central to FDA and DoJ actions. However, policy-driven initiatives, structural reorganization, and evolving legal frameworks introduced significant uncertainty.

As the pharmaceutical industry navigates 2026, companies must balance adaptation to new enforcement priorities with unwavering commitment to core compliance principles. Serious threats to public health invariably attract serious enforcement, regardless of administrative priorities. Organizations that maintain robust quality systems, invest in compliance infrastructure, and monitor emerging enforcement trends will be best positioned to manage regulatory risk in this dynamic environment, concludes the review.