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 FAR clause requiring certification that the contractor does not engage in “racially discriminatory DEI activities,” as defined by the clause, in connection with the performance of work under the contract. Under the guidance, agencies must also modify all existing FAR-covered contracts to include the requisite certification language by July 24, 2026, and contractors will be required to flow down the clause in their subcontracts.
False Claims Act
2026 Life Sciences Industry Outlook: Regulatory Environment
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 priorities, including deregulation, the use of policy levers to encourage domestic manufacturing and development, and efforts to reduce healthcare costs for American consumers. We expect this unpredictable atmosphere to continue into 2026. In particular, we anticipate regulatory and enforcement developments in FDA regulation, drug pricing and reimbursement, government contracts, tariffs, and antitrust oversight, although specific outcomes and impacts remain difficult to predict.
False Claims Act Risks for Cyber Device Manufacturers Arising under New Requirements Subject to FDA Enforcement Beginning October 1, 2023
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, a false record or statement material to a false or fraudulent claim.”[1] Through its qui tam provisions, the FCA also allows private citizens to file suit on behalf of the government for statutory violations.[2]