HHS Postpones SUNSET Rule Due to Significant Burden on FDA and CMS

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On March 19, the Department of Health and Human Services (HHS) announced that it will postpone the effective date of a recently finalized rule, “Securing Updated and Necessary Statutory Evaluations Timely,” (SUNSET Rule) until March 22, 2022. The SUNSET Rule would have required HHS to assess and review most of its regulations every 10 years to prevent the regulations from automatically expiring. Complying with the rule would have been particularly burdensome for the U.S. Food and Drug Administration, as the agency would have needed to review approximately 95% of its current regulations, thereby diverting resources from COVID-19 pandemic relief efforts, medical product applications, fulfillment of user fee commitments, and other public health issues, such as ongoing inspections and recalls.

Additionally, a coalition of health and consumer advocacy organizations filed suit against HHS, calling the rule a “ticking time bomb” that would eliminate thousands of existing public health and safety regulations across the department’s sub-agencies. As such, HHS is choosing to postpone the rule to evaluate legal concerns raised in pending litigation and the significant burden on the department in reviewing and assessing regulations. Read the update here.

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