Assistant Attorney General Colin M. McDonald of the National Fraud Enforcement Division issued a directive on October 1 providing guidance on the Division’s approach to corporate enforcement. It establishes four corporate enforcement priorities—focused primarily on fraud against the United States—and identifies ten factors governing charging and resolution decisions. It also centralizes review of corporate matters in the Division’s Corporate Enforcement Section and calls for the implementation of a Division whistleblower program. Finally, it signals that responsibility for corporate enforcement within DOJ remains in motion, with the Fraud Division claiming a central role.
This update summarizes the Global Benchmark for Efficient Drug Pricing Model, addresses key considerations for industry, and assesses what may come next.
This article describes the current state-of-play with MFN and key deal drafting considerations. Life sciences dealmaking is running at a record pace — straight into a pricing regime that is still being written. According to Gibson Dunn’s July biopharma M&A survey, the first half of 2026 saw 13 announced acquisitions of public biopharma targets ranging…
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…
