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This update summarizes noteworthy enforcement activity from the first six months of 2026. We discuss significant federal policy and state legislative developments, including the current status of state false claims statutes. We also analyze the most consequential court decisions of the first half of the year.
What began as a series of demand letters in July 2025 has evolved into something significantly more consequential. By February 2026, sixteen of the seventeen largest pharmaceutical manufacturers have signed Most-Favored-Nation (MFN) pricing agreements with the Trump administration, which commit them to Medicaid price parity, MFN pricing on new product launches, and participation in TrumpRx.gov…
Welcome to Part 5 of our 2026 Life Sciences Industry Outlook series. Today, we are wrapping up the week with a review of the regulatory environment for life sciences companies in 2025 and our expectations for what 2026 could bring. In 2025, life sciences companies faced a fast-moving regulatory environment shaped by the Trump administration’s…
On May 12, 2025, President Trump signed an Executive Order (“EO” or “Order”) “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients” aimed at significantly reducing U.S. prescription drug prices by aligning them with the lowest prices paid by other developed nations. According to the EO, drug manufacturers “deeply discount their products to access foreign markets…
Dear friends and colleagues, We are excited to introduce Biotech Briefings, providing Gibson Dunn’s commentary and perspectives on the legal, business, and regulatory issues shaping the life sciences industry. From groundbreaking developments in biopharma, medical devices, and diagnostics to the evolving landscape of IP, FDA and SEC regulation, Biotech Briefings delivers timely insights for companies,…
The False Claims Act (FCA) is one of the government’s chief tools to address false claims involving government funds, imposing liability on “any person who… knowingly presents, or causes to be presented, a false or fraudulent claim for payment” to the federal government or who “knowingly makes, uses, or causes to be made or used,…