United States: Healthcare

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Welcome to FDA in Flux — A Mintz newsletter tracking rapid changes in policy and agency actions that impact medical, life sciences, and consumer product investment decisions and development strategies.

The Department of Justice's National Fraud Enforcement Division and HHS Office of Inspector General have announced a coordinated policy that streamlines voluntary self-disclosures of healthcare fraud. Companies can now disclose potential criminal conduct to a single point of contact and receive benefits under both DOJ's Corporate Enforcement Policy and HHS-OIG's Self-Disclosure Protocol, eliminating the need for multiple simultaneous disclosures.

The Centers for Medicare & Medicaid Services has finalized the GLOBE Model, a mandatory rebate program for certain Medicare Part B drugs based on international price benchmarking. While the framework remains largely intact from the proposed rule, CMS dramatically narrowed the scope by adding three new drug exclusion categories and offering waivers for manufacturers participating in the GENEROUS Model, reducing projected savings by 97% and potentially affecting only four manufacturers.

The US FDA's Center for Devices and Radiological Health has published a discussion paper exploring how generative AI-enabled medical devices might be regulated, proposing a competency-based evaluation...

Hospital mergers require careful attention to pharmacy operations, which involve separate licenses, registrations, payor contracts and accreditation requirements that don't automatically transfer with the hospital. Overlooking pharmacy integration as a distinct transaction workstream can interrupt network participation, delay reimbursement and disrupt patients' access to medications, making early planning essential for regulatory compliance and operational continuity.

This digest examines the dual regulatory trajectory shaping virtual and digital health in mid-2026, as U.S. authorities intensify enforcement against telehealth fraud while simultaneously building institutional frameworks for artificial intelligence in healthcare delivery. The analysis tracks parallel developments in the EU and UK, where data protection authorities are scrutinizing automated decision-making systems and reassessing transatlantic data transfer mechanisms following recent U.S.

In April 2024, EPA designated perfluorooctanoic acid (“PFOA”) and perfluorooctanesulfonic acid (“PFOS”) as hazardous substances under the Comprehensive Environmental Response, Compensation, and Liability Act (“CERCLA”). As previously discussed in Re:Torts, industry groups challenged the designation, arguing that EPA misread the phrase “may present substantial danger” as requiring only a “possibility” of harm. The groups also argued EPA gave inadequate notice of its cost-benefit methodology and acted arbitrarily and capriciously.

California continues to lead the way in regulating foods and dietary supplements sold within its borders. Two recent developments are worth highlighting: the nation’s first statewide “Non-Ultraprocessed” food certification program, and a second-of-its-kind law restricting sales of certain dietary supplements and over-the-counter products to individuals under 18. Below, we break down both measures and what they may mean for food and supplement companies doing business in the state.