Health Law Advisor

The first half of 2026 has seen active U.S. Food and Drug Administration (FDA) enforcement across multiple regulatory domains. For regulated companies, monitoring the FDA’s enforcement priorities is critical to compliance and audit readiness.

Megan Robertson, Member of the Firm, examines the FDA’s recent enforcement actions, identifies six trends in the agency’s regulatory approach, and offers practical guidance for in-house counsel.

Key Takeaways

• The FDA is monitoring websites, social media, podcasts, and online storefronts for marketing claims that may be inappropriate based on a company’s regulatory status.
• The most prominent trend is continued enforcement against online telehealth platforms offering compounded GLP-1s. Companies must clearly distinguish health care services from drugs being compounded and sold by pharmacies.
• The Center for Drug Evaluation and Research is actively enforcing current Good Manufacturing Practice compliance. Recalls alone do not satisfy the FDA’s remediation expectations; companies must demonstrate comprehensive, root-cause corrections.
• Food facilities face enforcement action for inadequate Foreign Supplier Verification Programs on imported products, including produce, rice, matcha powder, and green tea.
• Form 483 responses are receiving heightened FDA scrutiny. Medical device manufacturers should prepare for potential increased Quality Management System Regulation enforcement as the year progresses.
• These warning letters were issued under the former FDA commissioner. In-house counsel should monitor for potential shifts in enforcement priorities under new leadership as the year progresses.

In recent weeks, two competing visions have emerged to legislatively modernize the federal 340B drug discount program (“340B Program”). On July 6, 2026, Representatives Scott Peters (D-CA) and Dr. John Joyce (R-PA) introduced the bipartisan House bill H.R. 9599, called the SECURE 340B Act (or “the 340B House Bill”), hailed as “the first-ever comprehensive, bipartisan proposal to modernize the 340B Drug Pricing Program since its creation in 1992.” This follows on the heels of the Senate bill “340B Drug Pricing Integrity and Affordability for Patients Act” that was issued as a discussion draft (“340B Senate Discussion Draft”), released by Sen. Bill Cassidy, chairman of the Senate Health, Education, Labor and Pensions Committee, on June 25, 2026. Cassidy’s 340B Senate Discussion Draft was touted as the first statutory update to the 340B Program in fifteen years.

One week after the U.S. Department of Justice on June 23, 2026, announced the results of its annual National Health Care Fraud Takedown—taking aim at Medicaid fraud and partnering with all 50 state Medicaid Fraud Control Units (MFCUs)—the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) denied recertification for New York’s MFCU and froze $60 million in annual federal funds for New York’s MFCU, effective July 1.

On the final day of the American Health Law Association’s Annual Meeting in New York, officials from the U.S. Department of Justice (DOJ), the Centers for Medicare & Medicaid Services (CMS), and the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) gave their own take on their agencies’ ramped-up enforcement efforts regarding health care fraud in mid-2026.

As the World Cup has captured the attention of viewers around the globe, so has the Food and Drug Administration (FDA) when it comes to taking enforcement action against regulated companies around the globe. We are at the midpoint of 2026, and several patterns are emerging based on FDA’s activity so far. Based on our own weekly tracking and analysis, we are sharing some of the key themes that have bubbled up as priorities for regulated industries and their stakeholders to watch as 2026 progresses.

On June 16, 2025, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule, “Medicare Drug Price Negotiation Program and Medicare Prescription Drug Benefit Program” (“Proposed Rule”), to codify the Medicare Drug Price Negotiation Program (“Negotiation Program” or “MDPNP”) and to establish new policies with respect to the MDPNP, for initial price applicability year 2029 and subsequent years.

In June 2026, the Trump administration announced nearly $2 million in federal grant funding for an Embryo Adoption Awareness and Services (EAA) program administered through the Department of Health and Human Services (HHS). While embryo adoption programs have existed at the federal level since 2002, the new grant notice contains language that may have far-reaching implications for reproductive health law, in vitro fertilization (IVF) regulation, and the ongoing legal debate over fetal personhood.

On June 15, 2026, Vermont Governor Phil Scott signed H. 583—imposing significant restrictions on private equity groups, hedge funds, and entities they control, including management services organizations (MSOs). The legislation prohibits interference with the clinical judgment of health care providers and establishes reporting requirements to an independent state agency regarding ownership and control.

On June 23, 2026, the U.S. Department of Justice (“DOJ”) announced the results of the annual National Health Care Fraud Takedown (“2026 Takedown”)—the first under DOJ’s new National Fraud Enforcement Division (“NFED”) announced on April 7. This year, the 2026 Takedown charged 455 defendants in connection with more than $6.5 billion in alleged fraud.

Although much of the content of the prosecutions is the same as in past years (e.g. wound care, opioids), Medicaid fraud—long the province of state Medicaid Fraud Control Units (“MFCUs”)—featured prominently in the 2026 Takedown. DOJ claims to have charged the largest number of Medicaid fraud defendants and Medicaid fraud loss in DOJ history: 295 defendants and over $518 million in alleged false claims submitted to Medicaid. Per the DOJ press release, the MFCUs of all 50 states participated, the highest number ever.

On June 18, 2026, the Food and Drug Administration (“FDA”) announced the submission of a proposed collection of information to the Office of Management and Budget (“OMB”) pertaining to the manufacturing, packaging, labeling, or holding of dietary supplements to ensure their quality (“FDA Notice”). Written comments (including recommendations) are due to OMB by July 20, 2026.