HHS Rescission of the Richardson Waiver and Unintended Legal Consequences for Drug and Device Manufacturers

On March 3, 2025, the U.S. Department of Health and Human Services (HHS) published a policy statement rescinding a decades-old administrative exemption for notice-and-comment rulemaking known as the Richardson Waiver. Written in 1971, the Richardson Waiver forgoes the Administrative Procedure Act’s (APA) statutory exemption from procedural rulemaking requirements for any rules and regulations relating to “agency management and personnel” or to “public property, loans, grants, benefits, or…
By: Faegre Drinker Biddle & Reath LLP