ARTICLE SUMMARY:
The fate of the highly controversial Trump administration regulation became more clear on March 18.
As we predicted in March 17th’s Pathways’ Picks, US HHS has delayed the start of the Trump administration’s SUNSET rule, which would require a large majority of rules from FDA, CMS, and other department agencies to be substantively reviewed every 10 years or they would expire. A March 18 notice delayed implementation of the rule for one year, until March 22, 2022, specifically citing a multi-plaintiff lawsuit against the rule filed earlier this month. The HHS notice says the lawsuit’s allegations—that the rule would severely hinder HHS operations and risk expiration of needed regulations—are credible. “The interests of justice require that the SUNSET final rule’s effective date be postponed pending judicial,” the department states.
“Given the scope of work and timeframes set forth in the SUNSET final rule, the review required under the rule would divert the Department’s resources from mission-critical endeavors for HHS agencies. For example, based on a count cited in the SUNSET final rule,” HHS explains “Under the timeline and definitions provided in the final rule, over 7,000 sections of the Code of Federal Regulations promulgated by the Food and Drug Administration (FDA) are more than ten years old or would become more than ten years old during the first five years the rule would be in effect, representing over 95 percent of its current regulations.”
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