Food, Drugs, Healthcare, Life Sciences

The Office of Inspector General has issued a Request for Information seeking stakeholder input on payments to clinical trial participants, exploring whether fraud and abuse regulations create barriers to patient participation in government healthcare programs.

Private equity firms face mounting congressional scrutiny as lawmakers prepare to investigate their growing presence in healthcare, housing, defense, emergency services and youth sports. With bipartisan concern over affordability and market consolidation intensifying ahead of the 2026 midterms, firms must assess their exposure and coordinate legal, government affairs and communications strategies to navigate potential investigations.

A pharmaceutical company's $46 million settlement reveals how falsified expense reports and disguised pharmacy payments led to record-breaking penalties under the Sunshine Act and False Claims Act. The case demonstrates the government's intensified scrutiny of manufacturer consulting arrangements and specialty pharmacy agreements that lack legitimate business purposes, while highlighting how meaningful cooperation can influence the structure and severity of enforcement actions.

Marshall Gerstein Partner Heather Kissling has been recognized by Crain's Chicago Business as a 2026 Notable Leader in Accounting, Consulting & Law for her leadership of the firm's Patent Prosecution Practice and her work guiding biotechnology clients through complex intellectual property matters. As Chair overseeing more than 120 legal professionals, Kissling has managed patent portfolios that have facilitated multibillion-dollar acquisitions and advanced RNA delivery technologies for cancer immunotherapy.

Amneal Pharmaceuticals has finalized its acquisition of Kashiv BioSciences for up to $1.1 billion, creating what the company describes as a fully integrated global biosimilars platform. The deal positions Amneal to launch multiple biosimilar products annually and capitalize on an unprecedented wave of biologic patent expirations in the coming years.

As global energy demand rises and pressure to decarbonise intensifies, biotechnology is emerging as a key driver of sustainable fuel innovation. This insight explores how advances in plant, microbial and algal biotechnology can support the transition to cleaner energy systems and contribute towards meeting United Nations Sustainable Development Goal 7.

Two pivotal participants in the legislative process behind the Food Quality Protection Act of 1996 will discuss how this groundbreaking pesticide legislation achieved unanimous bipartisan approval in Congress. The conversation explores the historical context, consensus-building process, and the law's continuing impact on pesticide regulation three decades later.

The Trump administration has revived its claims-based rebate model for select 340B drugs through a revised pilot program, while a new bipartisan Senate bill seeks to block this approach entirely and preserve the traditional discount system. Health systems must now navigate three competing reform proposals operating on different timelines, each with distinct compliance requirements and operational implications.

The U.S. Food and Drug Administration has proposed converting its voluntary GRAS notification program into a mandatory requirement, fundamentally changing how food substances enter the market. Companies would be required to submit GRAS notices for substances marketed under Generally Recognized as Safe provisions, with limited exceptions and a streamlined process for existing ingredients.