Health Law Advisor

On September 25, 2025, the Department of Justice announced a new office within the Civil Division—the Enforcement & Affirmative Litigation Branch—“dedicated to safeguarding public health and safety through proactive enforcement and high-impact affirmative litigation.” The creation of this new office restructures and consolidates affirmative litigation into a specialized branch to “hold powerful actors accountable, protect public health and safety, and enforce critical national policies.”

On October 15, 2018, the Centers for Medicare and Medicaid Services (CMS) unveiled its proposed rule requiring direct-to-consumer television advertisements for prescription drug and biological products to contain the list price (defined as the Wholesale Acquisition Cost) if the product is reimbursable by Medicare or Medicaid. Medical devices are not included in the proposed rule, although CMS seeks comment on how advertised drugs should be treated if used in combination with a non-advertised device. If finalized, the requirement will be sweeping and only purports to exclude ...