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On August 3, 2026, the California Supreme Court held in Gilead Tenofovir Cases (Aug. 3, 2026, S283862) ___ Cal.5th ___ (slip opn.), that a drug manufacturer owes no duty of care to users of a non-defective drug when deciding whether and when to commercialize an allegedly safer alternative drug. The Court reached that conclusion on…
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.
Life sciences companies should be aware of a new contract clause and accompanying guidance from the Federal Acquisition Regulatory Council (“FAR Council”) implementing President Trump’s Executive Order 14398, Addressing DEI Discrimination by Federal Contractors. Effective April 24, 2026, all new Federal solicitations and contracts subject to the Federal Acquisition Regulation (“FAR”) must contain a new…
Despite recent high-level U.S.-China talks, several recent developments in China have elevated international trade-related compliance risks and challenges for companies with commercial ties to mainland China or dealings with Chinese counterparties. While it is unclear the extent to which these developments move the needle in terms of practical legal and enforcement implications in China, there…
On February 18, 2026, FDA Commissioner Martin Makary and Vinay Prasad, then-Chief Medical and Scientific Officer and Director of the Center for Biologics Evaluation and Research, published a landmark policy announcement in the New England Journal of Medicine that a single adequate and well-controlled pivotal trial — supplemented by confirmatory evidence — is now the…
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…